Organisations running human clinical trials have an ethical obligation to make their research findings public to advance medical science and to reduce the time it takes for innovative treatments to reach the public.1 In 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) came together to release joint principles for responsible clinical trial data sharing to enhance research and scientific knowledge, advance patient care and improve public health.2 Vivli (a data-sharing and analytics platform) has been set up to facilitate the sharing of individual, participant-level data from completed clinical trials; it has published over 180 clinical trials reports between 2018 and 2023.3 4
Clinical trials are the cornerstone of new and innovative cancer treatments being made available to people living with cancer. However, clinical trials can be inefficient and ineffective. Recruitment of trial participants, flawed study design, inappropriate end-point measures, replication of existing data or small sample sizes are all areas where trials can be inefficient.5 6 Inefficiency in clinical trials can prolong the time it takes for treatments to be integrated into care. This can be due to trials having to be abandoned or re-examined due to their design not meaningfully measuring the clinical benefits. These inefficiencies can also result in huge financial losses.
Due to the importance of human clinical trials in making vital medications available to the public, organisations running these trials have an ethical obligation to make their research findings publicly available. This helps to enhance public trust – an especially important point if trials want to effectively recruit participants – and advance medical science.1 Although this notion is well established, between 2008 and 2012, only 45% of industry-led trials and 9% of government- or academic-funded trials reported their research findings on clinicaltrials.gov (and online database of clinical research studies and their results).1 This gap in reporting can cause delays in treatment development, which can also partially be attributed to a lack of faith in clinical trials outcomes from the public, making trial recruitment harder.5
In 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) came together to release joint principles for responsible clinical trial data sharing to enhance research and scientific knowledge, advance patient care and improve public health.2 The main principles of the responsible sharing of data are:7
- Safeguarding the privacy of patients
- Respecting the integrity of national regulatory systems
- Maintaining incentives for investment in biomedical research.
Biopharmaceutical companies who ascribe to these principles are expected to adopt and implement the following commitments:
- Enhancing data sharing with researchers – all eligible patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials are to be shared when requested. Use of this data is expected to be peer reviewed and published via open access.
- Enhancing public access to clinical trial information – all eligible trials will have a publicly available synopsis to help patients and healthcare professionals understand the results of clinical trials.
- Sharing results with the people who participate in a clinical trial – a factual summary of clinical trial results will be made available to all research participants in order to help inform and educate.
- Reaffirming commitments to publish clinical trial results – all clinical trial results should be considered for peer review and publication, regardless of positive or negative outcomes.
- Certifying procedures for sharing clinical trial information – policies and procedures to implement these commitments will be made publicly available.
What has been achieved?
Since the publication of the PhRMA-EFPIA principles, 22 of the top 23 biopharmaceutical companies have committed to sharing summary results.8
Vivli (an independent, non-profit organisation that has developed a global data-sharing and analytics platform) was founded in 2013 to provide a platform that helps its members to meet PhRMA-EFPIA’s principles.3 is the platform is secure and includes an independent data repository as well as an in-depth search engine. Vivli hopes to advance human health through clinical research data sharing, and to respect and honour the contributions of clinical research participants. The organisation also aims to increase the overall global capacity for effective data sharing and aggregation, and the reuse and analysis of valuable clinical research data. These goals all contribute towards Vivli’s ultimate vision of advancing science and improving human health.
Vivli has 49 members, including 29 biopharmaceutical companies, who are committed to sharing individual, participant-level data from completed clinical trials to serve the international research community.9 As well as a repository for clinical trial data, the Vivli platform acts as somewhere to share a company’s policies and procedures on data sharing.10 Between 2018 and 2023, the platform has facilitated the publication of over 180 research works.4
The EFPIA-PhARMA principles were an important step in making clinical trial data more widely available. However, these principles are now 10 years old and more needs to be done to ensure that data sharing is effective, and meets the ethical and scientific responsibility of researchers.
To mark 10 years since the inception of the EFPIA-PhARMA principles, a group of clinical researchers have recommended some amendments to the principles to ensure they are still fit for purpose.4 These include establishing a cohesive data-sharing ecosystem that provides public access to participant-level data, as well as clinical study reports, protocols, lay summaries, results, annotated case report forms, data dictionaries, data derivation documents and anonymisation guidance.4 Researchers have called for data sharing standardisation across the entire industry, with clear guidelines for sharing eligibility. It is also recommended that ‘The Good Pharma Scorecard’ (a ranking of pharmaceutical companies’ transparency practices) is significantly enhanced to quantify the rates of data sharing and number of citable open-access results made available by each company.4 11
- Anderson ML, Chiswell K, Peterson ED, et al. 2015. Compliance with Results Reporting at ClinicalTrials.gov. New England Journal of Medicine 372(11): 1031-39 [accessed: December 2023]
- EFPIA. 2013. EFPIA and PhRMA release joint principles for responsible clinical trial data sharing to benefit patients. Available here: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/130724-efpia-and-phrma-release-joint-principles-for-responsible-clinical-trial-data-sharing-to-benefit-patients/ [accessed: December 2023]
- Vivli. 2020. About Vivli: Overview. Available here: https://vivli.org/about/overview/ [accessed: December 2023]
- Modi ND, Kichenadasse G, Hoffmann TC, et al. 2023. A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies. BMC Medicine 21(1): 400 [accessed: December 2023]
- Fogel DB. 2018. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun 11: 156-64 [accessed: December 2023]
- EFPIA, PhRMA. 2016. EFPIA-PhRMA principles for responsible clinical trial data sharing: report on the 2016 member company survey. Brussels [accessed: December 2023]
- PhRMA, EFPIA. 2023. Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. Brussels [accessed: December 2023]
- Goldacre B, Lane S, Mahtani KR, et al. 2017. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ 358: j3334
- Vivli. 2023. Our Members. Available here: https://vivli.org/members/ourmembers/ [accessed: December 2023]
- EFPIA. 2023. Sharing clinical trial information. Available here: https://www.efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/sharing-clinical-trial-information/ [accessed: December 2023]
- Bioethics International. 2023. Good Pharma Scorecard. Available here: https://bioethicsinternational.org/good-pharma-scorecard/ [accessed: December 2023]