Washington, D.C. – The Executive Committee of the Pharmaceutical Research and Manufacturers (PhRMA) unanimously adopted a set of principles for the conduct of clinical trials and the communication of results of clinical trials. 

The voluntary principles describe the relationship of PhRMA member companies with others involved in clinical research and set forth the rules companies follow to protect the safety of research participants wherever the companies conduct clinical trials.  In the Principles, the PhRMA companies commit to the timely communication of all meaningful results of clinical trials, whether those results are positive or negative.  Further, the results are always to be communicated in an objective, accurate, balanced and complete manner.

“These principles reaffirm our members’ strong commitment to the safety of research participants to ensure the integrity of research and the timely communication of research results” said Alan F. Holmer, President of PhRMA.  “PhRMA members have always been committed, and remain committed, to sponsoring clinical research that fully complies with all legal and regulatory requirements.”

The principles, many of which reflect existing practices by the industry, become effective for trials begun after October 1, 2002.

Among other provisions, the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results provide that:

• Clinical trials are conducted in accordance with all applicable laws and regulations, as well as recognized principles of Good Clinical Practice (GCP), wherever in the world trials are conducted. 
• The independence of clinical investigators and others involved in clinical research is respected so they can exercise their own decision-making authority to protect research participants.  Compensation to clinical investigators will be reasonable and based on their work.  Compensation will not paid in the stock of the sponsor.
• Before trials begin, they are reviewed by Institutional Review Boards (IRBs) or Ethics Committees (ECs) that have the right to disapprove, require changes, or approve the study.  All participation in a clinical trial is based on informed consent, freely given without coercion.
• There will be timely communication of meaningful study results, regardless of the outcome of the study.  The results must be reported in an objective, accurate, balanced, and complete manner, with a discussion of the limitations of the study.  Study sponsors will not suppress or veto publications. 
• Any investigator who participated in the conduct of a multi-site clinical trial will be able to review relevant statistical tables, figures, and reports for the entire study at the sponsor's facilities, or other mutually agreeable location. 
• Consistent with the International Committee of Medical Journal Editors and major journal guidelines for authorship, the principles clarify that only those who make substantial contributions to a publication should receive acknowledgement as an author of or contributor to  the publication.

PhRMA represents the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives.  The industry, which invested more than $30 billion in 2001 in discovering and developing new medicines, is leading the way in the search for new cures.