Sharing clinical trial information

EFPIA and its members believe that sharing clinical trial information is in the best interests of patients, clinicians and medical research. We are committed to working with stakeholders to ensure that clinical trial information is shared responsibly taking into account patient anonymity, maintaining the integrity of regulatory systems worldwide and continuing to support innovation with appropriate arrangements for commercial-in-confidence information.

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 PhRMA-EFPIA 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

PhRMA-EFPIA Principles for responsible clinical trial data sharing

This commitment to data sharing enhances research and scientific knowledge, advances patient care and improves public health. Under the Principles, biopharmaceutical companies have dramatically increased the amount of information available to researchers, patients, and society.

You can access member companies’ commitment letters by clicking here.

Since the publication of the PhRMA-EFPIA 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 force on 1st January 2014 ans was updated in June 2023.

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.

Jurisdiction	Website	Scope of documents published
EU	Clinical Trials Register	Summary of results of phase 2-4 trials, conducted in the EU and certain trial outside EU relevant to pediatric drug development.
EU	Clinical Data Publication (CDP)	CTD Modules 2.5, 2.7.1-4, & 5 with select appendices of all trials that are part of a submission for marketing authorization of products in the EU since 2015.
EU	Clinical Trials Regulation \| European Medicines Agency (europa.eu)	Components of the clinical trial application, summary results, and clinical study reports (used in a marketing application) for subject to the EU CT Regulation (effective 31 January 2022).
Canada	Public Release of Clinical Information (PRCI)	CTD Modules 2.5, 2.7.1-4, & 5 with select appendices for trials that are part of medicinal products and medical devices marketing authorization submissions in Canada including retrospective requests for information in effect since March 2019.
Japan	JAPIC	CTD Module 1 and 2 documents used in marketing authorization submissions since 2013.
US	Home - ClinicalTrials.gov	Protocol and SAP (if not included in the protocol) submitted as part of clinical trial results information for those applicable clinical trials with a Primary Completion Date on or after January 18, 2017.