Table 1 Summary of the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing

1. Enhancing data sharing with researchers

On request from qualified medical and scientific researchers, companies will provide protocols, reports and patient-level clinical trial data for medicines that have been approved in both the EU and US.

Each company will establish a scientific review board that will include scientists and/or healthcare professionals who are not employees of the company.

Access will be consistent with patient informed consent and safeguarding privacy.

2. Enhancing public access to clinical study information

Companies will make available synopses of CSRs submitted to US and European regulatory authorities from 1 Jan 2014.

3. Sharing results with patients who participate in clinical trials

Companies will work with regulators to adopt mechanisms for providing a factual summary of clinical trial results and make the summaries available to research participants.

4. Certifying procedures for sharing clinical trial information

Companies will certify on a publicly available web site that they have established policies and procedures to implement these data sharing commitments.

5. Reaffirming commitments to publish clinical trial results

Results from all phase 3 clinical trials and any clinical trial results of significant medical importance should be submitted for publication, whether positive or negative, including results from discontinued development programs.