Transparency of ongoing and completed clinical trials and their results and access to participant level data have increased tremendously since 2014. For an overview of the data sharing ecosystem including the legal framework, policy and regulatory data sharing standards you can read the recently released Clinical Trial Data Sharing Ecosystem paper.
Delivering responsible transparency and data sharing is a process of continuous development, including alignment of companies’ policies to a rapidly evolving regulatory environment.
To support the sharing of clinical trial data, EFPIA and its member companies published and implemented the EFPIA/PhRMA principles for responsible sharing of clinical trial data. Going beyond the legislative requirements, the principles bring new levels of access to clinical trial data.
Principles for Responsible Clinical Trial Data Sharing
This commitment to data sharing enhances research and scientific knowledge, advance patient care and improve public health. Under the Principles, biopharmaceutical companies have dramatically increased the amount of information available to researchers, patients, and members of the public.
You can access member companies’ commitment letters by clicking here.
Since the publication of the EFPIA/PhRMA principles for responsible sharing of clinical trial data, companies have made great progress in developing processes for clinical trial data access schemes, translating principles into practice. We are now seeing data being shared with researchers through some particularly innovative solutions and processes.
Clinical trials are evolving with new approaches, technologies and designs. They remain an essential part of medical research as they aim at providing the community with the latest innovative treatments and state-of-the-art clinical practice. In the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. Industry is working with stakeholders to develop systems to maximise the potential of big data while protecting confidentiality of patient data, to further biomedical research.
EFPIA Clinical Trial Data Portal GatewayEFPIA's gateway for available clinical trial data offers a published list of member companies’ online portals aimed at advancing responsible clinical trial data sharing. A promise to develop these portals was established as part of joint EFPIA-PhRMA commitments on clinical trials data transparency, which came into full force on 1st January 2014.
- Daiichi Sankyo Company, Ltd
- Johnson & Johnson
- Merck Sharp & Dohme (MSD)
- Novo Nordisk
Regulatory Data SharingPublic disclosure of clinical trial information and documents is required in countries and regions around the world with European Union (EU), Canada, Japan, and the United States (US) requiring the most extensive regulatory document public disclosure.
Each region has specific objectives for public disclosure, including providing access to information for clinical studies performed under their respective jurisdiction, or that form the background for a marketing application of a product within their jurisdiction, i.e. to provide transparency on the regulatory decisions on products made available to their population.