On July 18, 2013, the two largest trade groups representing drug companies, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") and the Pharmaceutical Research and Manufacturers of America ("PhRMA"), announced their strengthened commitment to data openness. According to the joint press release issued by EFPIA and PhRMA,
[u]nder the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.This kinder, more open strategy may be designed to soften current antipathy towards drug companies. An anagram of the two organizations' acronyms may be prophetic of the industry's hopes: "Ah, IF PAMPER."
- Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.
- Companies will work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials.
- The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
- Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.