The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US Pharmaceutical Research and Manufacturers of America (PhRMA) released a joint set of principles detailing plans on 24 July to allow greater access to information from clinical trials. 'Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers' is to be implemented from January 2014.
This makes additional information relating to clinical trials available to the public, patients participating in clinical trials and qualified researchers. Its key principles are to:
- Provide summaries of clinical trial results for patients participating in the trials and improving their understanding of the process.
- Make publically available the synopses of clinical study reports that are submitted to regulators in Europe and the US upon approval of a new medicine or indication.
- Encourage companies to publish results from all phase III trials, even if those results do not back the effectiveness of a drug.
- Most significantly, enable researchers to request patient-level clinical data, study-level clinical trial data, full clinical study reports and protocols from clinical trials in patients for medicines approved in the US and the EU. While this sharing of data aims to benefit patients and foster scientific discovery, these requests will still be subject to certain terms, in order to protect patient privacy and confidential commercial information.
The Association of the British Pharmaceutical Industry (ABPI) has welcomed this agreement and explained that they have already launched measures to monitor disclosure in relation to the clinical trial transparency provisions contained in the ABPI Code of Practice.