Overall survival: A trusted benchmark, but not always best

The preferred clinical endpoint in oncology clinical trials, OS serves as a trusted benchmark, offering wide ranging advantages over other endpoints^[1][2]. Defined as the time from randomization to death, OS is precise, objective, and relatively easy to measure. Given its clinical robustness and patient relevance, OS is universally accepted by regulators and health technology assessment (HTA) bodies alike^[2][3].

However, in some disease settings, OS is associated with important limitations^[2]. The need for long studies makes OS an unsuitable endpoint in the case of slowly progressing and early-stage cancers, for example. Measurement of OS is also susceptible to confounding, particularly when involving multiple lines of therapies, patient crossover, and the occurrence of non-cancer related deaths. Furthermore, OS does not capture the broader priorities of patients and physicians; for example, when quality of life is a priority over prolonging survival^[2]. For pharmaceutical companies, these limitations can translate into time and financial constraints.

Alternative oncology-relevant endpoints provide opportunities to address these concerns, allowing the collection of data at earlier time points than with OS (Figure 1)^[1]. Such endpoints allow measurement of outcomes before starting subsequent therapies, giving a more direct measure of treatment efficacy. Some endpoints also offer broader value to patients too – besides being surrogate endpoints for OS, non-OS endpoints can provide standalone information, including on symptoms, function, treatment burden, and quality of life^[4].

Figure 1: Alternative oncology-relevant endpoints

Source: Modified from Delgado and Guddati 2021^[1]
Abbreviations: EQ-5D, EuroQol 5-dimensions index; NSCLC-SAQ, Non-Small Cell Lung Cancer Symptom Assessment Questionnaire; PROs, patient reported outcomes.

Why aren’t alternative oncology-relevant endpoints used more widely?

Despite their potential value, alternative oncology-relevant endpoints remain underused in clinical trial design. In 2021, non-OS endpoints accounted for just 16% of primary endpoints in Phase II or Phase III oncology trials, with the most common being pathological complete response, relapse rate and disease-free survival^[5].

Major barriers to the broader adoption of alternative oncology-relevant endpoints in clinical trials include a lack of agreement on their value and the uncertainty among payers that they accurately capture treatment benefits for patients and healthcare systems^[4][6]. While regulators are generally more receptive towards non-OS endpoints, accepting measures that are reasonably likely to predict clinical benefit, HTA bodies typically require validation of surrogacy^[4][6]. In general, guidelines published by HTA bodies indicate a preference for OS data or consider surrogate endpoints only where validation studies demonstrate strong correlation with survival^[6]. From a payer perspective, this caution is arguably expected; several therapies approved on the basis of improvements in outcomes such as progression-free survival (PFS) have not demonstrated OS benefits^[2]. Despite this, few agencies provide detailed methodological guidance for surrogacy validation^[7].

This uncertainty is further confounded by differences in the willingness of national HTA bodies to evaluate even well-established alternative oncology-relevant endpoints such as PFS^[6]. The resulting complexity feeds a vicious cycle: a lack of standardized methodologies for evidence generation leads to insufficient evidence to quantify the long-term benefits of non-OS endpoints, deterring HTA bodies from giving due consideration to these outcomes in decision making^[6].

Moreover, while HTA bodies continue to place particular importance on mortality, patients and clinicians often consider outcomes such as the avoidance of surgery or pain equally or more important than OS in some treatment settings^[6]. HTA bodies and payers can perceive patient reported outcomes (PROs) as more subjective, a point of difference that is reflected in the regional variations in the way PRO evidence is reviewed and considered in global HTA decision-making^[6]. This lack of alignment contributes to a lack of clarity around PRO requirements, reinforcing uncertainty among stakeholders.

Towards stakeholder alignment on alternative oncology-relevant endpoints

Overcoming the uncertainties and inconsistencies limiting broader adoption of alternative oncology-relevant endpoints requires concerted efforts from all stakeholders and a more harmonized approach towards their use^[4][6]. There is growing consensus that, by working together, the oncology community can move closer towards establishing sets of appropriate endpoints for specific cancer types and stages that have wide buy-in from regulatory authorities, reimbursement bodies, pharmaceutical developers, and patients themselves.

A key step towards this goal will be agreeing upon the endpoints that matter most to patients, which will almost certainly differ by cancer type and stage^[4][6]. For example, while extending survival may remain a priority in treatment settings with poor prognoses, for cancers where prognosis is improving, disease progression and quality of life may prove more valuable. Once alignment is reached on which outcomes are most valuable to patients, appropriate endpoints and PROs should then be defined through consultation with clinicians and healthcare professionals^[6].

There also exists an opportunity for greater harmonization in the methodologies used to validate endpoints and generate data^[4][6]. This is particularly important for PROs where there is lack of standardization in data collection methods, analysis and interpretation. Alignment on the levels of uncertainty that are acceptable to regulatory and HTA decision-makers and other stakeholders is also important, requiring greater transparency on the evidence needed to support regulatory approval and reimbursement in specific treatment settings^[4][6]. Much work has already been undertaken to establish the surrogate and standalone value of alternative oncology-relevant endpoints. However, the use of real-world evidence and other health economics and outcomes research (HEOR) studies to evaluate the long-term clinical and economic impact of treatments may help accelerate efforts to bridge these gaps^[6].

Global HTA bodies and professional organizations are already taking steps towards a more harmonized approach to assessing the surrogate and standalone value of non-OS endpoints. For example, an ongoing collaboration between HTA bodies including the National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC) and Canadian Agency for Drugs and Technologies in Health (CADTH) is developing methodological guidance and a new joint scientific advice procedure on the use of surrogate outcomes for cost-effectiveness analysis^[8]. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has also established a taskforce to set good practices for surrogacy evaluation and validation of the relationships between outcomes informing HTA decisions^[9]. These initiatives run alongside broader efforts to harmonize HTA decision-making processes within the European Union under Joint Clinical Assessment, providing an opportunity to promote greater standardization around non-OS endpoints^[10][11].

By supporting more transparent and consistent approaches for the evaluation of alternative oncology-relevant endpoints, these programs have the potential to promote more predictable outcomes in HTA decision-making – a necessary step towards building confidence in the value and suitability of alternative endpoints in clinical trial design.

Looking beyond overall survival

Overall survival remains an important measure of the value of cancer therapies, yet there exists a growing role for oncology-relevant endpoints beyond this ‘gold standard’. By considering patients’ needs, addressing uncertainties, and building consensus around the best outcomes to use in specific treatment settings, oncology-relevant endpoints beyond OS have the potential to facilitate faster and more cost-efficient access to novel cancer treatments.

Clarivate has supported our clients bring the next generation of innovative oncology treatments to market, empowering early-stage R&D and robust clinical trial design, through to navigating regulatory and market access pathways. Within Clarivate’s Evidence, Value and Access consultancy, our reimbursement dossiers, value stories, and objection handlers have supported clients achieve their market access goals in breast cancer, bladder cancer, leukemia and beyond, and our team have expertise with novel technologies such as CAR-T therapies. To learn more about our capabilities and how we can support you, please get in touch here.

This post was written by Richard Massey, Director, Value Communication and Clara Ricci, Senior Medical Writer.

References

^[1]Delgado, A. and A.K. Guddati, Clinical endpoints in oncology – a primer. Am J Cancer Res, 2021. 11(4): p. 1121-1131.

^[2]Cimen, A., et al., Shifting perspectives on the value of non-OS endpoints and PROs: Considerations across stakeholder groups to support oncology HTA decision-making. Journal of Clinical Oncology, 2023. 41(16_suppl): p. e13646-e13646.

^[3]McKee, A.E., et al., The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. Oncologist, 2010. 15 Suppl 1: p. 13-8.

^[4]Fameli, A., et al., Looking Beyond Survival Data: How Should We Assess Innovation in Oncology Reimbursement Decision Making. Values & Outcomes Spotlight, 2023. 9(5): p. S5.

^[5]IQVIA report, Evolving oncology endpoints – a new horizon for health outcomes 2021.

^[6]European Federation of Pharmaceutical Industries and Federations report, Improving the understanding, acceptance and use of oncology–relevant endpoints in HTA body / payer decision-making 2023

^[7]Grigore, B., et al., Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines. PharmacoEconomics, 2020. 38(10): p. 1055-1070.

^[8]NICE, International health technology assessment collaboration expands

^[9]ISPOR, Surrogate Endpoint Statistical Evaluation for HTA Decision Making

^[10]European Commission, Questions and Answers: Adoption of Regulation on Health Technology Assessment

^[11]European Commission, Health Technology Assessment

The post Beyond overall survival: Time to agree on the value of alternative oncology endpoints? appeared first on Clarivate.

London, U.K., May 1, 2024 – (PR Newswire) – Clarivate Plc (NYSE: CLVT), a leading global provider of transformative intelligence, today announced that its board of directors declared a quarterly dividend of $1.3125 per share on its 5.25% Series A Mandatory Convertible Preferred Shares (the “Preferred Shares”), payable in cash on June 3, 2024 to shareholders of record at the close of business on May 15, 2024.

On the mandatory conversion date, which is scheduled to occur on June 3, 2024, each Preferred Share will automatically and mandatorily convert into a number of ordinary shares of Clarivate (and cash in lieu of any fractional ordinary shares) based on the average volume weighted average price (“VWAP”) of Clarivate’s ordinary shares over a 30-trading day period that begins on, and includes, April 18, 2024 and is scheduled to end on, and include, May 30, 2024 (the “valuation period”). If such VWAP is (i) greater than $31.20, then the mandatory conversion rate will be 3.2052 ordinary shares of Clarivate per Preferred Share, (ii) less than or equal to $31.20 but equal to or greater than $26.00, then the mandatory conversion rate will be a number of ordinary shares of Clarivate per Preferred Share equal to $100.00 divided by such VWAP and (iii) less than $26.00, then the mandatory conversion rate will be 3.8462 ordinary shares of Clarivate per Preferred Share. The mandatory conversion rate will be announced following the end of the valuation period. The above description of the terms of the Preferred Shares is not complete and is subject to, and qualified in its entirety by reference to, the “Statement of Rights” for the Preferred Shares, which is filed as Exhibit 3.2 to Clarivate’s annual report on Form 10-K for the fiscal year ended December 31, 2023.

Cautionary Note Regarding Forward-Looking Statements

This communication contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements, which express management’s current views concerning future business, events, trends, contingencies, financial performance, or financial condition, appear at various places in this communication and may use words like “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “see,” “seek,” “should,” “strategy,” “strive,” “target,” “will,” and “would” and similar expressions, and variations or negatives of these words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on management’s current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. These forward-looking statements involve a number of risks and uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include those factors discussed under the caption “Risk Factors” in our annual report on Form 10-K, along with our other filings with the U.S. Securities and Exchange Commission (“SEC”). However, those factors should not be considered to be a complete statement of all potential risks and uncertainties. Additional risks and uncertainties not known to us or that we currently deem immaterial may also adversely affect our business operations. Forward-looking statements are based only on information currently available to our management and speak only as of the date of this communication. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, except as otherwise required by securities and other applicable laws. Please consult our public filings with the SEC or on our website at www.clarivate.com.

#  #  #

About Clarivate

Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit clarivate.com.

Investor Relations Contact

Mark Donohue, Head of Investor Relations

investor.relations@clarivate.com

Media Contact

Amy Bourke-Waite, Senior Director, Corporate Communications

newsroom@clarivate.com

The post Clarivate Declares Dividend on Mandatory Convertible Preferred Shares appeared first on Clarivate.

Liver cancer and focal liver lesions

Liver cancer ranks as the third-leading cause of cancer-related deaths worldwide.^[5] The dominant form of liver cancer is hepatocellular carcinoma (HCC), accounting for 80% of primary liver cancers.^[6] HCC is a type of FLL; however, FLLs also encompass other malignant lesions, such as intrahepatic cholangiocarcinoma and hepatic metastasis, as well as benign lesions such as hepatic haemangioma and focal nodular hyperplasia. Early detection and accurate characterization of FLLs are crucial for optimal treatment decisions and prognostic predictions.^[7]

FLLs are often found incidentally during imaging for other purposes, such as the assessment of abdominal pain or during surveillance for liver metastases in patients with non-liver cancer.^[8] Three main imaging modalities are used for the detection and characterization of FLLs: conventional ultrasound is often the modality to first detect FLLs, after which contrast-enhanced computed tomography (CECT), contrast-enhanced magnetic resonance imaging (CEMRI), or contrast-enhanced ultrasound (CEUS) are used for FLL characterisation.^[8][9][10]

Key modalities used for liver imaging

Ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) are non-invasive imaging modalities, and each relies on different underlying physical principles (Figure 1). Ultrasound uses sound waves that pass into the body and bounce back from the tissues inside, like an echo. Different tissue types reflect the sound waves differently and software is used to process these echoes to create images of the body.^[11][12]

CT uses a series of X-rays to build images by acquiring multiple projections of the same location from different orientations. Tomographic reconstruction then generates 3D cross-sectional images of the body. The individual X-ray images quantify the reduction in X-ray intensity as they pass through tissues. Different tissue types absorb different levels of radiation (e.g. bones absorb the most) and the resulting differential generates contrast.^[11][12]

MRI employs strong magnets to create a magnetic field in which protons (mostly hydrogen atoms in water molecules) in the body will preferentially align with the magnetic field. By pulsing a specific radiofrequency through the patient’s body, the protons can be forced to spin out of alignment with the magnetic field. After the radiofrequency is turned off, the protons relax back to their resting alignment and release energy. Different tissue types have different relaxation properties, and the released energy can be measured to create an image.^[11][12]

Figure 1: Non-invasive modalities for liver imaging

Enhancing contrast to enhance categorisation

For all three imaging modalities, contrast agents can be used to improve their diagnostic capability. Contrast agents for CEUS consist of microbubbles containing an inert gas stabilized by a shell, enhancing the echo (and thus signal intensity) from the blood.^[13][14] Contrast agents for CECT typically contain iodine atoms that increase image contrast by absorbing X-rays.^[15] CEMRI often uses gadolinium-based contrast agents that shorten the relaxation times of proton nuclei in the tissues, improving signal intensity from contrast-enhanced tissues.^[16][17]

For characterization of FLLs, particularly in patients at high risk of HCC, a Liver Imaging Reporting and Data System (LI-RADS) has been developed to categorize FLLs from LR-1 (definitely benign) to LR-5 (definitely HCC). LI-RADS algorithms specific to CECT/CEMRI and CEUS are available.^[18] Categorization considers factors such as the lesion size and flow of contrast agent through the liver. Because the liver has a dual blood supply (from the hepatic artery and the portal vein), three distinct phases can be assessed during imaging, in which the injected contrast agents (for any of the modalities) ‘wash in’ and ‘wash out’ of the liver: the arterial phase, portal venous phase, and late phase. Depending on the pattern of contrast enhancement of FLLs compared with the surrounding liver parenchyma, the FLLs can be categorized by CEUS, CECT and/or CEMRI.^{[19][20][21][22]}

Advantages and limitations of modalities for liver imaging

All three contrast-enhanced modalities play a role in charactering FLLs, and each has advantages and limitations. For example, CEUS offers real-time imaging, has wide accessibility, can be performed with the clinician/radiographer at the patient’s bedside and is relatively inexpensive.^[10][23][24] However, CEUS has limited penetration depth, affecting imaging in overweight/obese patients, and only one lesion can be studied at a time. ^[22][23][24] Conversely, CECT and CEMRI can visualize deep structures and enable evaluation of the whole liver. ^{[10][15][23][24]} A limitation of CECT is that it uses ionising radiation, and contrast agents for both CT and MRI have restricted use in patients with renal impairment due to nephrotoxic effects.^[10][23][25] CECT and CEMRI cannot be performed in real-time and imaging is performed at predetermined times following contrast agent administration.^[22] They are also performed in a dedicated room, where the patient is confined to a large scanner on their own and may experience discomfort.^[24]

Depending on multiple factors, one modality may be preferred over the other, or multiple modalities may be used, complementing each other.^[8][10][22] Understanding the benefits and limitations of these techniques is necessary to guide the selection of the most appropriate imaging modalities for specific individuals, and assist in accurate characterization and diagnosis of FLLs to avoid delays in diagnosis and treatment, thereby improving patient outcomes.^[4] Such insights can also help optimize medical workflows, and ultimately reduce healthcare utilisation.^[9][24][26]

The Clarivate Value Communication team, helps life science companies present the benefits of innovative and highly technical medical technologies to market access stakeholders in clear, impactful ways. We specialize in the development of robust and compelling value communication materials, including value story slide decks, global value and reimbursement dossiers, objection handlers and publications. We also have extensive experience in primary payer and KOL research, and in developing interactive client workshops and training.

To learn more about our capabilities and how we can support you, please get in touch at https://clarivate.com/products/life-sciences-and-healthcare-consulting-services/evidence-value-access-consulting/.

This post was written by Ulrike Jahnke, Medical Writer, and Paul Cowling, Medical Writer.

References

^[1]Devarbhavi H, Asrani SK, Arab JP, Nartey YA, Pose E, Kamath PS. Global burden of liver disease: 2023 update. J Hepatol. 2023 Aug;79(2):516-537

^[2]World Liver Day website.

^[3]European Association for the Study of the Liver (EASL) press release

^[4]Singh S, Hoque S, Zekry A, Sowmya A. Radiological Diagnosis of Chronic Liver Disease and Hepatocellular Carcinoma: A Review. J Med Syst. 2023 Jul 11;47(1):73

^[5]Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249

^[6]Rumgay H, Ferlay J, de Martel C, Georges D, Ibrahim AS, Zheng R, Wei W, Lemmens VEPP, Soerjomataram I. Global, regional and national burden of primary liver cancer by subtype. Eur J Cancer. 2022 Jan;161:108-118

^[7]Marrero JA, Ahn J, Rajender Reddy K; Americal College of Gastroenterology. ACG clinical guideline: the diagnosis and management of focal liver lesions. Am J Gastroenterol. 2014 Sep;109(9):1328-47

^[8]Algarni AA, Alshuhri AH, Alonazi MM, Mourad MM, Bramhall SR. Focal liver lesions found incidentally. World J Hepatol. 2016 Mar 28;8(9):446-51

^[9]O’Brien M, Oliver L, Proctor N, Siakantari M, Cantin P, Griffin CP, Stenberg B. Assessing the impact and resource implications of contrast-enhanced ultrasound on workflow of patients with incidental focal liver lesions on the UK national health service. Acta Radiol Open. 2023 Jun 13;12(6):20584601231183131

^[10]Burrowes DP, Medellin A, Harris AC, Milot L, Lethebe BC, Wilson SR. Characterization of Focal Liver Masses: A Multicenter Comparison of Contrast-Enhanced Ultrasound, Computed Tomography, and Magnetic Resonance Imaging. J Ultrasound Med. 2021 Dec;40(12):2581-2593

^[11]Medical Imaging Signals and Systems. Second Edition. Eds: Prince CL, Links JM. Pearson Education Inc. 2015

^[12]Medical Imaging Systems. An Introductory Guide. Eds: Maier M, Steidl S, Christlein V, Hornegger J, Springer Open 2018

^[13]Frinking P, Segers T, Luan Y, Tranquart F. Three Decades of Ultrasound Contrast Agents: A Review of the Past, Present and Future Improvements. Ultrasound Med Biol. 2020 Apr;46(4):892-908

^[14]Yusefi H, Helfield B. Ultrasound Contrast Imaging: Fundamentals and Emerging Technology. Front Phys. 2022;10:791145

^[15]Owens TC, Anton N, Attia MF. CT and X-ray contrast agents: Current clinical challenges and the future of contrast. Acta Biomater. 2023 Nov;171:19-36

^[16]Lohrke J, Frenzel T, Endrikat J, Alves FC, Grist TM, Law M, et al. 25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives. Adv Ther. 2016 Jan;33(1):1-28

^[17]Chandra T, Mohan S. Role of Contrast in MR Imaging. Top Magn Reson Imaging. 2016 Aug;25(4):151-6

^[18]Marks RM, Masch WR, Chernyak V. LI-RADS: Past, Present, and Future, From the AJR Special Series on Radiology Reporting and Data Systems. AJR Am J Roentgenol. 2021 Feb;216(2):295-304

^[19]Bargellini I, Battaglia V, Bozzi E, Lauretti DL, Lorenzoni G, Bartolozzi C. Radiological diagnosis of hepatocellular carcinoma. J Hepatocell Carcinoma. 2014;1:137-48

^[20]Dietrich CF, Nolsoe CP, Barr RG, Berzigotti A, Burns PN, Cantisani V, et al. Guidelines and Good Clinical Practice Recommendations for Contrast-Enhanced Ultrasound (CEUS) in the Liver-Update 2020 WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS. Ultrasound Med Biol. 2020 Oct;46(10):2579-604

^[21]Kim TK, Noh SY, Wilson SR, Kono Y, Piscaglia F, Jang HJ, et al. Contrast-enhanced ultrasound (CEUS) liver imaging reporting and data system (LI-RADS) 2017 – a review of important differences compared to the CT/MRI system. Clin Mol Hepatol. 2017 Dec;23(4):280-9

^[22]Wilson SR, Lyshchik A, Piscaglia F, Cosgrove D, Jang HJ, Sirlin C, et al. CEUS LI-RADS: algorithm, implementation, and key differences from CT/MRI. Abdom Radiol (NY). 2018 Jan;43(1):127-42

^[23]Yang Q, Zheng R, Zhou J, Tang L, Zhang R, Jiang T, et al. On-Site Diagnostic Ability of CEUS/CT/MRI for Hepatocellular Carcinoma (2019-2022): A Multicenter Study. J Ultrasound Med. 2023 Dec;42(12):2825-38

^[24]Islam, S.K.M.S., Nasim, M.A.A., Hossain, I., Ullah, D.M.A., Gupta, D.K.D., Bhuiyan, M.M.H. (2023). Introduction of Medical Imaging Modalities. In: Zheng, B., Andrei, S., Sarker, M.K., Gupta, K.D. (eds) Data Driven Approaches on Medical Imaging. Springer, Cham

^[25]American College of Radiology (ACR). ACR Manual On Contrast Media – 2023

^[26]Thrall JH. Appropriateness and imaging utilization: “computerized provider order entry and decision support”. Acad Radiol. 2014 Sep;21(9):1083-7

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London, U.K., April 15, 2024 – (PR Newswire) – Clarivate Plc (NYSE: CLVT), a leading global provider of transformative intelligence, announced today it will report its financial results for the first quarter before the market opens on Wednesday, May 8, 2024. The press release and earnings supplement, with accompanying financial information, will be available on the Clarivate investor website at https://ir.clarivate.com.

The Company will host a conference call and webcast at 9:00 AM Eastern Time on Wednesday, May 8, 2024 to review the results. The webcast is open to all interested parties and may include forward-looking information.

The live webcast of the earnings call will be accessible through the investor relations section of the Company’s website. To join the webcast please visit https://events.q4inc.com/attendee/319586540.

Interested parties may access the live audio broadcast by dialing +1 404-975-4839 or toll-free +1 833-470-1428 (in North America) and +44 208 068 2558 or toll free +44 808 189 6484 (internationally). The conference ID number is 143104.

A replay of the webcast will also be available on https://ir.clarivate.com beginning two hours after the conclusion of the live call and will remain available for one year.

#  #  #

About Clarivate

Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit clarivate.com.

Category: Earnings

Source: Clarivate Plc

Investor Relations Contact

Mark Donohue, Head of Investor Relations

investor.relations@clarivate.com

Media Contact

Amy Bourke-Waite, Senior Director, Corporate Communications

newsroom@clarivate.com

The post Clarivate to Report First Quarter 2024 Results on May 8, 2024 appeared first on Clarivate.

London, UK – April 1, 2024 Clarivate Plc (NYSE: CLVT), a leading global provider of transformative intelligence, announced today that in conjunction with the recent launch of Clarivate in the Age of AI video webinar presentations, the Company’s Chief Financial Officer and its three segment Presidents participated in panel discussions at investor conferences in March 2024. The recordings, which cover various topics including how Clarivate is leveraging content and solutions, incorporating Generative AI strategies and investing to realize its long-term growth potential, can be accessed as follows:

• March 7: Oppenheimer Capital Markets Tech and Analytics Virtual Bus Tour. The discussion with Jonathan Collins, Executive Vice President and Chief Financial Officer, and Bar Veinstein, President, Academia& Government, can be accessed at https://clarivate.com/AI/investor-webinar/.
• March 14: BofA Securities Information and Business Services Conference. The discussion with Mr. Collins and Henry Levy, President, Life Sciences & Healthcare, can be accessed at https://bofa.veracast.com/webcasts/bofa/infoservices2024/id8q5vjH.cfm.
• March 21: Jefferies Business Services Summit. The discussion with Mr. Collins and Gordon Samson, President, Intellectual Property, can be accessed at https://clarivate.com/AI/investor-webinar/.

The recently released Clarivate in the Age of AI video webinars for the Academia & Government, Life Sciences & Healthcare and Intellectual Property segments can be accessed at https://clarivate.com/AI/investor-webinar.

About Clarivate

Clarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit www.clarivate.com

Cautionary Note Regarding Forward-Looking Statements

This communication contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements, which express management’s current views concerning future business, events, trends, contingencies, financial performance, or financial condition, appear at various places in this communication and may use words like “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “see,” “seek,” “should,” “strategy,” “strive,” “target,” “will,” and “would” and similar expressions, and variations or negatives of these words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on management’s current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. These forward-looking statements involve a number of risks and uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include those factors discussed under the caption “Risk Factors” in our annual report on Form 10-K, along with our other filings with the U.S. Securities and Exchange Commission (“SEC”). However, those factors should not be considered to be a complete statement of all potential risks and uncertainties. Additional risks and uncertainties not known to us or that we currently deem immaterial may also adversely affect our business operations. Forward-looking statements are based only on information currently available to our management and speak only as of the date of this communication. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, except as otherwise required by securities and other applicable laws. Please consult our public filings with the SEC or on our website at www.clarivate.com.

Category: Webcast

Source: Clarivate Plc

Investor Relations Contact

Mark Donohue, Head of Investor Relations

investor.relations@clarivate.com

+1 (215) 243 2202

Media Contact

Amy Bourke-Waite, Senior Director, Corporate Communications

newsroom@clarivate.com

The post Clarivate Leadership Presents at Recent Investor Conferences appeared first on Clarivate.

Special collections include unique material in a variety of formats, from rare historical documents to contemporary records and photographs and everything in between, such as books, newspapers and articles. For advanced scholars, local historians, journalists or even people tracing their family genealogy, these collections hold valuable insights and information.

Libraries are increasingly making the effort to digitize these collections, in part to preserve fragile, irreplaceable materials but also as part of a process to make them more discoverable and accessible to users who are primarily online. That process, however, can be complex and labor intensive, especially for catalogers tasked with manually identifying and inputting vast amounts of critical metadata, whether for this digitized material or “born-digital” content such as photographs and more.

At Ex Libris, we are committed to helping libraries harness innovative technologies, so they are better able to connect their communities with the vital information they seek. This commitment includes a vision for incorporating artificial intelligence (AI) into the process to enhance metadata generation and elevate usability – and usage – of digital special collections and other digital content.

What could an AI-enhanced digital cataloging tool do?

We’re currently working with beta testers from our passionate user community to better understand the challenges of special collection librarians and catalogers at academic institutions and to help develop a forward-looking solution that can make their work easier and more robust.

For example, AI has strong capabilities when it comes to identifying the faces of people in pictures – this technology is a popular feature on Apple, Google and social media platforms. Now, imagine if a cataloger could leverage this ability for organizing hundreds or thousands of photos in digital collections, quickly and with a high degree of accuracy.

We envision a not-too-distant future where a cataloging tool enhanced with AI could handle such a traditionally time-consuming and nearly unmanageable task so library catalogers can free up time to focus on aspects of their work where AI is weaker, such as studying and understanding handwritten content and providing deeper insights into digital resources. When it comes to digitized materials like handwritten marginalia in books and articles or letters, human intervention is imperative and could now more easily be prioritized.

This article is the fifth in our series on AI developments at Ex Libris. Last month we shared our developments with Our AI Metadata Generator, and the profound impact this scalable technology will have on catalogers, library staff, and library users.

At Ex Libris, the use of AI technology is always done to solve the real challenges of real users, librarians and libraries. We respect the need for privacy and intellectual property considerations, and above all, we understand the importance of using trusted scholarly content to drive learning outcomes and increase library impact.

Academic libraries are vital for accessing trustworthy scholarly material. Download this whitepaper to learn how new methods and technologies, like Generative AI, can enhance the library’s discovery experience and align it with dynamic user expectations.

The post Artificial Intelligence Blog Series: Metadata Generation for Digital Content appeared first on Clarivate.

Around the world, college students are struggling post-pandemic. In the U.S. the national average score on the ACT college placement exam declined to its lowest point in 30 years. In the U.K., researchers are warning that higher ed students are facing increased pressures that significantly reduce their resilience. In the classroom, faculty are reporting high levels of absenteeism and low levels of engagement.

It’s a perfect storm: with the advent of generative artificial intelligence (AI), overwhelmed, under-confident students can be quickly lured to look for help in general-purpose chatbots, exposing them to dangers such as bias and content hallucinations.

Now, ProQuest^®, part of Clarivate, is collaborating with its community of educators to address these issues by harnessing AI’s powerful abilities and applying them in a responsible, reliable research companion for students. Currently in beta with top universities, ProQuest Research Assistant achieves a milestone in next generation content discovery by enabling students to use conversational inquiry to explore vast, vetted and authoritative content.

AI that’s rooted in traditional academic values

ProQuest Research Assistant is being tested in an academic library staple: ProQuest One Literature, a destination resource built on a foundation of high quality, authoritative content – an extraordinary range of full text prose and poetry as well as plays, periodicals, essays, video, imagery and editor-developed topical content. ProQuest is developing its AI initiatives in alignment with traditional academic principles and strong community governance. The rigorous approach to testing and validating results is shaping a powerful new research tool that will be integrated in ProQuest solutions across major disciplines.

Navigating knowledge: The AI-powered journey in ProQuest One

ProQuest Research Assistant supports the exploratory phase of the research process and allows researchers to use natural language inquiries to navigate millions of high-quality, trusted sources of full text academic works. Their journey will enable them to discover documents and get summarized responses to research questions that propel exploration.

Patti Ginnis, Vice President, Product Management, ProQuest Information Solutions said: “Our aim is to augment the researcher’s journey, fostering discovery and introducing diverse concepts and comprehensive explorations at the point of need. Our academic AI responds and nurtures the student’s journey, paving the way for the insights that might have eluded them in traditional searches.”

With the ProQuest Research Assistant, students who default to searching on something they already know will be guided to a diversity of perspectives, broadening their vistas to think critically about what they’re learning so they can draw their own conclusions.

Ginnis continues: “This journey isn’t just about efficiency and recall; it’s about integrity, learning and productivity. ProQuest Research Assistant is rooted in traditional values of academia, ensuring that every step aligns with the core values of scholarly pursuits. We believe the synergy between technology and scholarly values is what creates and nurtures curious minds.”

Get involved

Community collaboration is key to the strategy behind ProQuest Research Assistant and the variety of AI initiatives underway at Clarivate. The company is working with librarians, students and faculty to embed AI within its academic offerings in ways that are both responsible and effective.

To explore how you can participate in the next phase of the beta, please email us at pq1devpartners@clarivate.com.

The post ProQuest®, part of Clarivate™, launches AI-powered research assistant appeared first on Clarivate.

Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward. This is just one example.

Our aim to ensure inclusive and equitable quality education and promote lifelong learning opportunities for all

In today’s rapidly evolving world, ensuring inclusive and equitable quality education for all is paramount.

With over 130 million students benefiting from our solutions, we have a significant impact on education. Our tools empower students to enhance their learning and research experiences and accessing valuable resources. We serve as trusted partners to over 26,000 public and academic libraries, providing essential tools and resources.

We value diversity and have incorporated Diversity, Equity and Inclusion (DEI) resources into our practices, so that all three of our corporate values: Own your actions, aim for greatness and value every voice, align with the development of DEI’s to help build trust, pursue hard-to-get content from underrepresented communities and historically silenced groups, and respond to the needs of research institutions, libraries and their patrons.

ProQuest: Leading the Way in DEI

For decades ProQuest has been creating DEI resources and building diverse collections of educational materials for libraries, enhancing greater representation of collections focusing on underrepresented regions and communities. Primary source research collections deal with topics such as women’s equality, incarceration and discrimination, disabilities, racial injustice and more.

One person in seven experiences disability, yet the story of this community and its contributions is largely absent from the scholarly record.

To identify and fill the gaps in our collections, ProQuest works with the academic community including academic advisory boards, partners with faculty on projects and talks regularly to their librarian partners and archivists. The accumulated well of knowledge is preserved in a multimedia collection – Disability in the Modern World which enables students and researchers to include this important piece of the puzzle in their research.

In September of 2023, Clarivate and ProQuest introduced ‘LibLists‘, an innovative platform empowering librarians to share collection curation expertise. The inaugural LibList, “Inclusivity in Healthcare” by Maria King, addresses diversity in healthcare education, offering a vital resource for neurodivergent students. With over 50 titles, King’s list is indispensable for health sciences libraries.

In 2022, we added archival material from an organization called Humanity and Inclusion that won a Nobel Prize for their international campaign to ban landmines. The new collection brings together pamphlets, reports, case studies, workshop material, manuals, guides and videos created by Humanity and Inclusion from 1985-2021, highlighting this important work to a global audience for the first time.

Language Inclusivity and Bias Mitigation

At Clarivate we review metadata and indexing terms to eliminate potential harm to marginalized communities. Our choice of indexing terms is non-discriminatory and reflects evolving inclusive language. We actively implement processes and technologies to prevent, detect and mitigate any biases.

As champions of inclusive education, we advance diversity, equity, and inclusion through innovative solutions. By providing cutting-edge tools, resources, and comprehensive collections, we empower individuals to explore, learn and grow. Together, we create an inclusive and equitable educational landscape.

Continuing to Learn, Act and Grow Together

Like so many organizations on a similar journey to sustainability, we realize we have a lot more to do. We all have an essential role to play to drive positive, meaningful impact for years to come.

We welcome you to join the conversation at clarivate.com/sustainability-at-clarivate/ as we work hard to build a more sustainable company that is focused on the bigger picture and driving long-term sustainable success for our customers, our community and our world.

The post How Clarivate works towards SDG 4: Ensuring inclusive and equitable quality education appeared first on Clarivate.

Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward. This is just one example.

SDG 9 aims to build resilient infrastructure, promote inclusive and sustainable industrialization, and foster innovation. At Clarivate, we are proud to play a significant role in supporting these goals and driving positive change – it aligns perfectly with our mission to drive innovation, support sustainable industrial practices, and create a robust infrastructure for a better future.

Our aim to build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation

Our commitment to accelerating innovation is evident through our partnerships with 90 percent of the world’s top R&D investors. By harnessing the power of data and insights, we empower our customers along the innovation lifecycle, helping them bring groundbreaking ideas and solutions to market faster. Through our Web of Science and Derwent World Patents Index, we compile a vast library of global research and invention information to create a vast library of humanity’s current level of scientific and technological knowledge.

But we don’t stop at collecting data. At Clarivate, we enhance the data and metadata by classifying it for technical approach and industrial use, providing valuable insights into the impact, expenditure, and rarity of innovations. With over 200 million individual documents detailing research and development outcomes, we equip policy makers with a comprehensive understanding of the global technology landscape, enabling them to inform sustainable policies.

At Clarivate, we will celebrate this year’s World IP Day by delving into the synergy between IP and SDGs, acknowledging their pivotal role in driving innovation and creativity for a unified future. To forge our shared path toward the SDGs, a paradigm shift in our lifestyle and activities is imperative. World IP Day 2024 provides a platform to contemplate the role of intellectual property in fostering and magnifying innovative solutions crucial for our collective future.

Top 100 Global Innovators

How we will live in the 2030s is being defined now. Our health, our prosperity and the sustainability of our very world is built on the ideas created today. Some, more than others, define our future – those who employ thousands of researchers, who invest in science and engineering, who are happy to see results outside the current quarter and who practice leadership. Those that know that innovative new ideas and solutions to current problems influence not just their financials but foster genuine improvement in the human condition and the health of our habitats. Those that choose to lead. For 12 years Clarivate has found these companies.

To recognize the organizations at the forefront of the global innovation ecosystem, we publish the Top 100 Global Innovators report. These companies and organizations consistently demonstrate exceptional innovation performance. In our 2023 report, we also identified the 50 research organizations most frequently cited by the Top 100 Global Innovators 2023, highlighting the intellectual powerhouses behind engineered solutions.

“At Philips, our purpose to improve people’s health and wellbeing through meaningful innovation is the great driving force behind everything we do. It’s why we exist, and it’s never been more relevant than in these challenging times…It’s a great honor to be recognized as a Top 100 Global Innovator for the 10th consecutive year, along with so many esteemed companies. And we are excited about the future and the potential of innovation to help solve the world’s most pressing issues.”

In 2023, we found that Asia continues to lead the global innovation landscape, with Japan topping the list once again with 38 organizations and other countries like Taiwan 11, South Korea five, and Mainland China four, making significant contributions. The United States 19, France and Germany seven, also play crucial roles.

The electronics and computing equipment industry emerges as the largest sector among the Top 100 Global Innovators, followed by chemicals and materials, semiconductors, and automotive.

“At Clarivate, we aim to bring clarity to the complex. Our focus is to pore over what humanity knows today and to put forward the insight that explores all possible horizons; that enables transition and transformation. We acknowledge the Top 100 Global Innovators 2023 – companies and organizations that know that innovative ideas and solutions to current challenges not only bring rewards to their businesses but foster genuine improvements in society.”

Continuing to Learn, Act and Grow Together

Like so many organizations on a similar journey to sustainability, we realize we have a lot more to do. We all have an essential role to play to drive positive, meaningful impact for years to come.

We welcome you to join the conversation at clarivate.com/sustainability-at-clarivate/ as we work hard to build a more sustainable company that is focused on the bigger picture and driving long-term success for our customers, our community and our world.

The post How Clarivate works towards SDG 9: Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation appeared first on Clarivate.

In late 2023, Research Professional News, an editorially independent part of Clarivate, surveyed research office leaders and staff as well as researchers around the world, taking a close look at the challenges facing them today and in the future. The resulting report Research Offices of the Future reveals a clear consensus among respondents about the number one priority of the research office: finding and securing more funding. The survey also revealed that a key barrier to earning grants and awards is researchers’ lack of engagement with their research office colleagues.

“What surprised me the most in this report was the huge discrepancy between researchers and research offices, how they engage and see each other’s value,” said Silke Blohm, Founding Director, 4Sciences Group, in a panel discussion about the report’s findings. She views researchers’ ‘lack of engagement’ as a “big challenge, also a big opportunity, because this is an area where the research office has some control.”

Research offices around the world are struggling to build more effective relationships with researchers with lean staff and increasing workloads. In a prior panel discussion, research office leaders Meg Sparling (University of California, Davis), Daniel Moseke (University of Arizona) and Emily Brashear (Washington State University) stressed the importance of simplifying workflows throughout the research enterprise, shifting time from administrative tasks to activities that are crucial to winning funding.

The time-stretched (and stressed) research environment

Nearly 50% of research office staff rate time-pressures among the top three challenges of their job. “[There is] limited awareness and understanding of the quality threshold needed to win funding and the time it takes to write proposals of this level,” notes a U.K. research development leader.

Research Offices of the Future also notes that 25% of research offices are staffed by fewer than 10 people… sometimes much fewer. Sparling, the research funding coordinator at University of California, Davis, a tier one research institution where grants and awards approach $1 billion annually, supports hundreds of researchers. Despite her own monumental workload, she understands that researchers are just as busy.

Indeed, a 2021 report from the Organization for Economic Cooperation and Development (OECD) in the U.S. points to a researcher environment that’s overworked and underpaid. It says that one in five researchers is working more than 55 hours a week and earning less than $30,000 per year. Respondents to the Research Professional News survey agree: “Researchers are frustrated with the workload model and lack of administrative support for both teaching and research activities,” said a member of a U.K.-based research office team.

The workload of researchers also has a disabling impact on the research office. Research Offices of the Future quotes one senior member of a research office in Australia: “Time-poor academics find it difficult to effectively plan, draft and submit the highest quality and competitive proposals with limited support.”

Lifting burdens on both sides of the relationship

Building engagement between researchers and research office staff to find and convert opportunities into winning proposals requires a macro view of what will make both sides of the relationship more successful. For example, support staff need tools that cut straight to relevant opportunities and make them easy to share with researchers and their teams. Researchers need tools that make it easy to share opportunities with their teams, labs, collaborators and students. Research units benefit from tools that enable them to display opportunities on their websites.

A growing number of research leaders are using three key strategies to engage with researchers and win more funding:

• Streamline the process of finding relevant opportunities
• Improve communication with researchers
• Help researchers be more autonomous

1. Streamline opportunity searches

Wading through hundreds of calls for funding to find relevant opportunities is both time-consuming and prone to error through oversight. New technology solutions that use funding opportunity databases as a foundation can automate searches and relieve a significant time burden. With these solutions, staff can cut through opportunities from thousands of funders with searches that precisely match research interests and eligibility criteria.

The University of Arizona is a tier one research institution with $955 million in research expenditures that are spread across a host of research areas undertaken by the university’s 3,000+ faculty: a challenge for the university’s Research Development Services (RDS) staff. Moseke reports they’ve tamed the workload by using Pivot-RP, a research funding solution from Clarivate, to automate opportunity searches. An additional short-cut in Pivot-RP automatically matches funding opportunities to researcher profiles, enabling the staff to simplify the task of direct outreach.

A note of caution: these technologies are only as good as the underlying database. Databases should be updated continually with content that’s editorially curated by experts.

2. Make communications more effective

Panelists noted the dilemma of reaching researchers: their email inboxes are overflowing, a barrier to delivering relevant opportunities in a timely way.

It’s sage advice for research offices in reviewing their communications to researchers. Newsletters that include too few opportunities are unlikely to be relevant to the majority of the researchers receiving them and waste staff and readers’ time. Conversely, pages and pages of broad opportunities are time-consuming to create and a challenge for researchers to wade through.

Emily Brashear, leader of the one-person research office at Washington State University, has solved that dilemma by sending a university-branded newsletter that “everyone pays attention to.” The newsletter includes links to lists of opportunities in Pivot-RP, organized by research interest. The targeted links enable the newsletter to be both a quick read and relevant to nearly every recipient.

Help researchers help themselves

Ironically, a key strategy for building researcher engagement is to help them be more self-sufficient. Making it easy for researchers to search effectively for funding on their own reduces the workload on research offices. That shifts time into more strategic work like helping researchers craft winning proposals or enrich their profiles.

Sparling creates custom, saved searches using Pivot-RP for each campus research initiative and for trending research topics. Then, she makes the funding opportunity searches public so that all users can access them. In addition to including the links in newsletters, she provides them as search widgets to relevant campus websites. Her goal: “Meet researchers where they are,” she said.

Further, she’s enabling teams and groups within the university to become funding information hubs. She creates custom groups using email addresses and populates them with saved searches. “They can easily share specific funding opportunities with the whole group,” she said.

By embedding a Pivot-RP search box directly within research office webpages, UC Davis and other institutions make it easy for researchers to search directly in the Pivot-RP database. University of Arizona and Washington State University include pre-scoped links to relevant funding searches from Pivot-RP directly on research office webpages, streamlining the process for researchers even more.

Another way researchers can help their chances of finding funding success is by familiarizing themselves with the types of projects funders have funded in the past. In addition to high-level previously awarded grants information searchable in Pivot-RP, researchers will be able to perform deeper analysis on this same data with the new release of the Grants Index on the Web of Science platform. Researchers will have quick access to information on previously awarded grants from around the world at two different points in their workflow, during their Web of Science discovery and during their Pivot-RP funding search. This will build a deeper understanding of what’s already been funded in an area and who is winning the funding – information that can help them align their new projects and proposals with funder goals.

Do more with what you have

Research Offices of the Future reveals that research office leaders’ three biggest challenges are budget, time pressures and attracting staff. Looking ahead five years, these leaders believe cost pressures will be the biggest driver of change in their operations. Streamlining now, building richer connections with researchers without adding to staff, alleviates burdens today and prepares research offices to succeed in the future.

Let us help you build researcher engagement to win more funding

Request a trial or get more information about Pivot-RP at: https://discover.clarivate.com/ExLibris-research-funding-product-request

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