PhRMA Principles on Conduct of Clinical Trials
Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results
Developing new therapies to treat disease and to improve quality of life is a long and complex process. A critical part of that process is clinical research, the study of a pharmaceutical product in humans. Without clinical research studies, no new medicines could be made available to patients.
The PhRMA Board of Directors unanimously endorsed strengthening PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results to help assure that clinical research conducted by America’s pharmaceutical research and biotechnology companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.
Among the key changes in the revised Principles: Increased transparency about clinical trials for patients and healthcare professionals; enhanced standards for medical research authorship; and improved disclosure to better manage potential conflicts of interest in medical research. The revised principles took effect on October 1, 2009.
In sponsoring and conducting clinical research, PhRMA members place great importance on respecting and protecting the safety of research participants. Principles for the conduct of clinical research are set forth in internationally recognized documents, such as the Declaration of Helsinki and the Guideline for Good Clinical Practice of the International Conference on Harmonization. The principles of these and similar reference standards are translated into legal requirements through laws and regulations enforced by national authorities, such as the Food and Drug Administration.
PhRMA members have had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulator agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.
PhRMA adopts these voluntary principles to fortify our members’ commitment to the highest standards for ethics and transparency.
These Principles are supplemented by the Principles for Responsible Clinical Trial Data Sharing which were adopted by PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013. Under those Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to clinical study information, and reaffirm their commitment to publish clinical trial results.