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A 10-year update to the principles for clinical trial data sharing by … – BMC Medicine


  • PhRMA, EFPIA. ‘Principles for responsible clinical trial data sharing’: PhRMA and EFPIA; 2013. Available from: https://www.efpia.eu/media/qndlfduy/phrmaefpiaprinciplesforresponsibledatasharing2023.pdf.

  • Blasimme A, Fadda M, Schneider M, Vayena E. Data sharing for precision medicine: policy lessons and future directions. Health Aff. 2018;37(5):702–9.

    Article 

    Google Scholar
     

  • Doshi P, Godlee F, Abbasi K. COVID-19 vaccines and treatments: we must have raw data, now. BMJ. 2022;376:o102.

    Article 
    PubMed 

    Google Scholar
     

  • El Emam K, Rodgers S, Malin B. Anonymising and sharing individual patient data. BMJ. 2015;350:h1139.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. 2015;313(8):793–4.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Loder E. Data sharing: making good on promises. BMJ. 2018;360:k710.

    Article 

    Google Scholar
     

  • Bonini S, Eichler H-G, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014;371(26):2452–5.

    Article 
    PubMed 

    Google Scholar
     

  • Modi ND, Abuhelwa AY, McKinnon RA, Boddy AV, Haseloff M, Wiese MD, et al. Audit of data sharing by pharmaceutical companies for anticancer medicines approved by the US Food and Drug Administration. JAMA Oncol. 2022;8(9):1310–6.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • TransCelerate. Clinical data transparency – de-identification & anonymization. 2023. Available from: https://www.transceleratebiopharmainc.com/assets/clinical-data-transparency/.

  • Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016;3(1):160018.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Department of Health and Human Services. U.S. Department of Health and Human Services. Clinical trials registration and results information submission – a rule by the Health and Human Services Department; 2016. Available from: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission.

  • National Institute of Health. NIH Office of data science strategy announces new initiative to improve access to NIH-funded Data. 2022. Available from: https://datascience.nih.gov/news/nih-office-of-data-science-strategy-announces-new-initiative-to-improve-data-access.

  • European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. 2014. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536.

  • ClinicalTrials.gov. FDAAA 801 and the final rule (Section 801 of the Food and Drug Administration Amendments Act of 2007). 2022. Available from: https://clinicaltrials.gov/ct2/manage-recs/fdaaa.

  • European Medicines Agency. Clinical Trials Information System (CTIS): online modular training programme. 2023. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-ctis-online-modular-training-programme.

  • European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. 2022. Available from: http://data.europa.eu/eli/reg/2014/536/oj.

  • Food and Drug Administration. FDA continues to support transparency and collaboration in drug approval process as the clinical data summary pilot concludes. United States of America Government; 2020. Available from: https://www.fda.gov/news-events/press-announcements/fda-continues-support-transparency-and-collaboration-drug-approval-process-clinical-data-summary.

  • Health Canada. Public release of clinical information: consultation. Government of Canada; 2019. Available from: https://www.canada.ca/en/health-canada/programs/consultation-public-release-clinical-information-drug-submissions-medical-device-applications.html.

  • Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: The National Academies Press; 2015.


    Google Scholar
     

  • International Committee of Medical Journal Editors. Recommendations. 2022. Available from: https://www.icmje.org/recommendations/.

  • National Academies Press (US). Reflections on sharing clinical trial data: challenges and a way forward: Proceedings of a Workshop. 2020. https://doi.org/10.17226/25838.

  • World Health Organization. Joint statement on public disclosure of results from clinical trials. 2017. Available from: https://www.who.int/news/item/18-05-2017-joint-statement-on-registration.

  • White House Office of Science and Technology Policy. Ensuring free, immediate, and equitable access to federally funded research. 2022. Available from: https://www.whitehouse.gov/ostp/news-updates/2022/08/25/ostp-issues-guidance-to-make-federally-funded-research-freely-available-without-delay/.

  • Goldacre B, Lane S, Mahtani KR, Heneghan C, Onakpoya I, Bushfield I, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ. 2017;358:j3334.

    Article 
    PubMed 

    Google Scholar
     

  • Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. BMJ. 2019;366:l4217.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: a narrative review. Postgrad Med. 2011;123(5):194–204.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • European Medicines Agency. Background to clinical data publication policy Europe. European Medicines Agency; 2023. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication/background-clinical-data-publication-policy.

  • Hopkins AM, Rowland A, Sorich MJ. Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability. BMC Med. 2018;16(1):165.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of clinical trial data from industry-sponsored cardiovascular trials. J Am Heart Assoc. 2016;5(4):e003307.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Hemmings R, Koch A. Commentary on: Subgroup analysis and interpretation for phase 3 confirmatory trials: white paper of the EFSPI/PSI working group on subgroup analysis by Dane, Spencer, Rosenkranz, Lipkovich, and Parke. Pharm Stat. 2019;18(2):140–4.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Statisticians in the pharmaceutical industry. Data Sharing SIG; 2023. Available from: https://psiweb.org/sigs-special-interest-groups/data-sharing-working-group.

  • Bamford S, Lyons S, Arbuckle L, Chetelat P. Sharing Anonymized and Functionally Effective (SAFE) data standard for safely sharing rich clinical trial data. Appl Clin Trials. 2022;31(7/8):30-43.

  • Hoffmann T, Glasziou P, Beller E, Goldacre B, Chalmers I. Focus on sharing individual patient data distracts from other ways of improving trial transparency. BMJ. 2017;357:j2782.

    Article 
    PubMed 

    Google Scholar
     

  • Odame E, Burgess T, Arbuckle L, Belcin A, Jones G, Mesenbrink P, et al. Establishing a basis for secondary use standards for clinical trial. Appl Clin Trials. 2023. https://www.appliedclinicaltrialsonline.com/view/establishing-a-basis-for-secondary-use-standards-for-clinical-trials.

  • Gomes DGE, Pottier P, Crystal-Ornelas R, Hudgins EJ, Foroughirad V, Sánchez-Reyes LL, et al. Why don’t we share data and code? Perceived barriers and benefits to public archiving practices. Proc R Soc B Biol Sci. 1987;2022(289):20221113.


    Google Scholar
     

  • Tedersoo L, Küngas R, Oras E, Köster K, Eenmaa H, Leijen Ä, et al. Data sharing practices and data availability upon request differ across scientific disciplines. Sci Data. 2021;8(1):192.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013;3(2):e002496.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med. 2012;9(4):e1001201.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med. 2013;10(10):e1001526.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Hodkinson A, Dietz KC, Lefebvre C, Golder S, Jones M, Doshi P, et al. The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors. Syst Rev. 2018;7(1):117.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Egilman AC, Ross JS, Herder M. Optimizing the data available via Health Canada’s clinical information portal. CMAJ. 2021;193(33):E1305-e6.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Cochrane Library. A statement in support of EMA’s clinical study report transparency policy. 2020. Available from: https://www.cochrane.org/news/statement-support-emas-clinical-study-report-transparency-policy.

  • European Medicines Agency. Clinical data publication. European Union; 2022. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication.

  • ClinicalTrials.gov. Submit studies to ClinicalTrials.gov PRS. 2023. Available from: https://clinicaltrials.gov/ct2/manage-recs.

  • Minssen T, Rajam N, Bogers M. Clinical trial data transparency and GDPR compliance: implications for data sharing and open innovation. Sci Public Policy. 2020;47(5):616–26.

    Article 

    Google Scholar
     

  • Marquardsen M, Ogden M, Gøtzsche PC. Redactions in protocols for drug trials: what industry sponsors concealed. J R Soc Med. 2018;111(4):136–41.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Hopkins AM, Modi ND, Abuhelwa AY, Kichenadasse G, Kuderer NM, Lyman GH, et al. Heterogeneity and utility of pharmaceutical company sharing of individual-participant data packages. JAMA Oncol. 2023. https://doi.org/10.1001/jamaoncol.2023.3996.

  • Campbell D, McDonald C, Cro S, Jairath V, Kahan BC. Access to unpublished protocols and statistical analysis plans of randomised trials. Trials. 2022;23(1):674.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Grady D, Thomas K. Moderna and Pfizer reveal secret blueprints for coronavirus vaccine trials. The New York Times; 2020. Available from: https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html.

  • Statham EE, White SA, Sonwane B, Bierer BE. Primed to comply: individual participant data sharing statements on ClinicalTrials.gov. PLoS One. 2020;15(2):e0226143.

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Kirkpatrick E, Gaisford W, Williams E, Brindley E, Tembo D, Wright D. Understanding plain English summaries. A comparison of two approaches to improve the quality of plain English summaries in research reports. Res Involv Engagem. 2017;3(1):17.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • European Union. Clinical Trials Expert Group of the European Commission representing Ethics Committees and National Competent Authorities: Good Lay Summary Practice. 2021. Available from: https://health.ec.europa.eu/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en.

  • Barnes A, Patrick S. Lay summaries of clinical study results: an overview. Pharmaceut Med. 2019;33(4):261–8.

    PubMed 

    Google Scholar
     

  • EFPIA. Implementing “Good Lay Summary Practice”. 2022. Available from: https://www.efpia.eu/news-events/the-efpia-view/efpia-news/implementing-good-lay-summary-practice/.

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4.

    Article 

    Google Scholar
     

  • ClinicalTrials.gov. Why should I register and submit results? 2023. Available from: https://clinicaltrials.gov/ct2/manage-recs/background.

  • Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–60.

    Article 
    CAS 
    PubMed 

    Google Scholar
     

  • Axson SA, Mello MM, Lincow D, Yang C, Gross CP, Ross JS, et al. Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ Open. 2021;11(7):e053248.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Sender D, Clark J, Hoffmann TC. Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles. J Clin Epidemiol. 2020;124:69–74.

    Article 
    PubMed 

    Google Scholar
     

  • Christian O, David M, Maximilian S, Edith M, Florian N. Status, use and impact of sharing individual participant data from clinical trials: a scoping review. BMJ Open. 2021;11(8):e049228.

    Article 

    Google Scholar
     

  • Burns NS, Miller PW. Learning what we didn’t know—the SPRINT data analysis challenge. N Engl J Med. 2017;376(23):2205–7.

    Article 
    PubMed 

    Google Scholar
     

  • Eichler H-G, Sweeney F. The evolution of clinical trials: can we address the challenges of the future? Clin Trials. 2018;15(1):27–32.

    Article 
    PubMed 

    Google Scholar
     

  • Rockhold F, Bromley C, Wagner EK, Buyse M. Open science: the open clinical trials data journey. Clin Trials. 2019;16(5):539–46.

    Article 
    PubMed 

    Google Scholar
     

  • Vivli. Public disclosures. 2023. Available from: https://vivli.org/resources/public-disclosures/.

  • Rydzewska LHM, Stewart LA, Tierney JF. Sharing individual participant data: through a systematic reviewer lens. Trials. 2022;23(1):167.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • World Health Organization. International Clinical Trials Registry Platform (ICTRP). 2023. Available from: https://www.who.int/clinical-trials-registry-platform.

  • National Library of Medicine. ClinicalTrials.gov. U.S. Department of Health and Human Services; 2023. Available from: https://clinicaltrials.gov/.

  • European Medicines Agency. EU Clinical Trials Register. European Union; 2023. Available from: https://www.clinicaltrialsregister.eu/ctr-search/search.

  • ClinicalStudyDataRequest. 2023. Available from: https://www.clinicalstudydatarequest.com/.

  • Vivli. Center for Global Clinical Research Data. 2023. Available from: https://vivli.org/.

  • Bioethics International. Good Pharma Scorecard. 2023. Available from: https://bioethicsinternational.org/good-pharma-scorecard/.

  • Kochhar S, Knoppers B, Gamble C, Chant A, Koplan J, Humphreys GS. Clinical trial data sharing: here’s the challenge. BMJ Open. 2019;9(8):e032334.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Keerie C, Tuck C, Milne G, Eldridge S, Wright N, Lewis SC. Data sharing in clinical trials – practical guidance on anonymising trial datasets. Trials. 2018;19(1):25.

    Article 
    PubMed 
    PubMed Central 

    Google Scholar
     

  • Rockhold FW. Statistical controversies in clinical research: data access and sharing – can we be more transparent about clinical research? Let’s do what’s right for patients. Ann Oncol. 2017;28(8):1734–7.

    Article 
    CAS 
    PubMed 

    Google Scholar
     



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    Lucas Leclerc

    Tel un mélodiste des pixels, je suis Lucas Leclerc, un Compositeur de Contenus Digitaux orchestrant des récits qui fusionnent la connaissance et l'imagination. Mon passage à l'Université Catholique de Lyon a accordé une symphonie à ma plume. Telle une partition éclectique, mes écrits se déploient des arcanes de la sécurité internationale aux méandres de la politique, des étoiles de la science aux prédictions des bulletins météo. Je navigue entre les lignes avec la même aisance qu'un athlète soucieux de sa santé. Chaque article est une note de transparence, une mélodie d'authenticité. Rejoignez-moi dans cette composition numérique où les mots s'entremêlent pour former une toile captivante de connaissances et de créativité, où la sécurité mondiale danse avec les étoiles, où les sphères politiques se fondent avec la météorologie, et où chaque paragraphe est une sonate pour la compréhension globale.

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