Transparency, and access to results, of clinical studies are ethical obligations that we as industry take seriously. On 1st January 2014, EFPIA/PhRMA published their Principles for Responsible Clinical Trial Data Sharing subsequently referred to the “Principles” which demonstrate industry’s commitment to support innovation and to comply with and go beyond the legal requirements of clinical trial data sharing in both the European and US based member companies. 

Since then, a lot has happened in the transparency environment for clinical trials. For example, EMA has published in 2016 their Clinical Data Publication policy (formerly called Policy 70) and as of 31st January 2022 the EU Clinical Trials Regulation 536/2014 has come into application. Both significantly increased the transparency requirements for trial sponsors. The COVID-pandemic has also underlined the need for rapid comprehensive publication of clinical trial results to maintain public trust and to enable healthcare professionals to assess the newest scientific evidence in a timely manner. EMA exceptional transparency measures addressed the information needs of the public during a major health crisis. At the same time, the surge of interest has raised ethical questions about the appropriate timing of data sharing,e.g. while studies are still ongoing, as the scientific validity of the final results of the trial might be negatively impacted. 

In order to assess the status of the implementation of the Principles among member companies, EFPIA conducted a survey of compliance during July-September 2020. 

The following 5 aspects were investigated: 

1. Enhancing data sharing with researchers 

2. Enhancing public access to clinical study information - CSR synopsis availability 

3. Sharing results with patients who participate in clinical trials – lay summaries 

4. Certifying procedures for sharing clinical trial information 

5. Reaffirming commitments to publish clinical trial results. 

CONCLUSIONS 

• The compliance rate to the 5 EFPIA-PhRMA Principles was generally very high, however, some aspects did not reach 100%. 

• Challenges with the implementation of the Principles were seen in specific process demands in regard to data sharing. Overall, companies commit to the data sharing but new technologies and platforms for different ways of sharing data have evolved since the origin of the Principles. 

• A large proportion of companies report disclosure and data sharing activities that go beyond the commitments, such as providing Lay Language Summaries (also referred to by some sponsors as Trial Result Summaries or Plain Language Summaries) to trial participants and/or the general public. 

• 100% compliance with the legal requirements of ClinicalTrials.gov, EudraCT and EU Clinical Trials registries was reported by members. 

EFPIA and its member companies are committed to responsible clinical data sharing and are looking forward to continued engagement with the stakeholders to ensure transparency of clinical trial data while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research. We keep evaluating our members' commitment to the Principles and are working with our members to revise some content of the Principles to align with the ever-changing legislative and policy environment of clinical trials transparency and data sharing.