Enhancing public health through responsible Clinical Trials Data Sharing

Clinical trials play a key role in medical innovation. By providing a robust method for scientists to test the efficacy and safety of new medicines, they have helped to transform modern healthcare – saving and improving countless lives in the process.
Over the past 15 years, the need for greater transparency of ongoing and completed clinical trials has been in the spotlight. EFPIA and its members are committed to enhancing public health through responsible sharing of clinical trial data.
We have come a long way in a short time. And we continue to make progress in balancing the goal of data sharing with the needs to safeguard patient privacy, respect the integrity of clinical research conform to the integrity of national regulatory systems, and maintain incentives for investment in biomedical research. This is vital to ensuring that future clinical trials can continue and deliver the new medicines that patients need.
As we mark International Clinical Trials Day (20 May 2022), this is a good moment to reflect on the progress of recent years, how the pandemic impacted trial data, and the changes brought by the implementation of the Clinical Trial Information System (CTIS) under the EU Clinical Trials Regulation.    
Advancing access to trial data
Since 2014, industry has sought to lead the way. EFPIA, together with the US trade association PhRMA, and our member companies have followed the PhRMA-EFPIA principles for responsible CT data sharing.
These commitments go beyond what is required by law and ensured new levels of access to clinical trial data. The principles enhance data sharing with researchers; improve public access to clinical study information; share results with trial participants; certify procedures for sharing trial information; and reaffirm commitments to publish clinical trial results.
These strong commitments were matched with action. EFPIA has launched the EFPIA Clinical Trial Data Portal Gateway which lists companies’ online portals for voluntary clinical trial data sharing data. Researchers are encouraged to request datasets directly from the sponsor’s data sharing portals or multi-sponsor platforms.
Since the EFPIA/PhRMA principles were published, biopharmaceutical companies have dramatically increased the amount of information available for researchers, patients, and members of the public. We are of the clear view that sharing data in a responsible manner enhances research and scientific knowledge, serving to advance patient care and improving public health.
Adapting to the data-driven age
These principles provide a solid foundation from which to maximise the impact of clinical trials while respecting privacy and commercial sensitivities. However, the world of research is evolving at speed, driven by changes in how trials are conducted. Data is at the heart of this new era of medical science.
Clinical trial data can now be complemented by real-world data from patient registries, hospitals and primary care. Clinical research programmes increasingly include observational studies as well as clinical trials. Unlocking the potential of big data in research, while protecting confidentiality of participants and ensuring clinical research can continue in an integral way, is the shared priority of industry, regulators, and patients.
Demand for transparency of clinical trial results increased during the COVID-19 pandemic. Exceptional measures were taken to make data available earlier and pushing to publicly release even more details. However, clinical trial information is fragmented in different databases, and it seems to be difficult to find and access easily by most stakeholders. In addition, the public attention on trials of COVID-19 vaccines and treatments – and, in some cases – participants’ shared their experiences during the trial on social media, posing increase challenges for protecting privacy and data anonymisation.
Meanwhile, new policies and systems can also play a part in improving access to information on clinical trials. The CTIS is expected to facilitate better access for patients and healthcare professionals to ongoing and new clinical trials and to determine their relevance to an individual patient. In addition, EFPIA member companies are committed to the new legal requirement of EU Clinical Trials Regulation of developing lay summaries of clinical trial results and publication at CTIS to facilitate access for patients and the public in general.
As we move into the dynamic era of data-driven clinical research, EFPIA and its members remain committed to responsible data sharing. We will continue to work with stakeholders to improve access to information and to take the lead on medical innovation. 

>> Learn more on clinical trial information sharing here <<

Wendy Wimmer

Director of Clinical Data Disclosure & Transparency at Merck Sharp and Dohme, co-leader of EFPIA Clinical Trial...
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Julie Holtzople

Senior Director Clinical Transparency & Data Sharing at AstraZeneca, co-leader of EFPIA Clinical Trial Transparency...
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Silvia Garcia

Silvia Garcia is working as Senior Manager Regulatory, Drug development & Manufacturing at European Federation...
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