PhRMA Shows Its Committment to Transparency With Revised Principles on Conduct of Clinical Trials

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors announced yesterday their unanimous endorsement of revised principles to increase transparency in medical research through their newly revised PhRMA Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results.  The revised principles are part of an effort to encourage behavior that benefits the healthcare community and the public through objectivity in research and strengthened transparency in medical studies.

PhRMA states that the Principles of Conduct, which are to take effect on October 1, 2009, will:

Fortify our commitment to patients and healthcare professionals by increasing transparency in clinical trials, enhancing standards for medical research authorship and improving disclosure to manage potential conflicts of interest in medical research.

The pharmaceutical and biotech industries have been under recent pressure to become more transparent, specifically concerning the disclosure and publication of clinical trial results, the disclosure of physician payments/reimbursement for conducting clinical trials, and authorship standards.

PhRMA’s President and CEO, Billy Tauzin, said about the revised Principles:

Our member companies have a longstanding commitment to ethical conduct of clinical trials and to transparency in reporting.   But, we’ve heard the calls that we could do more. And these revised Principles, which come on the heels of our updated Code on Interactions With Healthcare Professionals, further renew our pledge to ‘practice what we preach.’  We hope that all companies that sponsor clinical research and publish results on websites and in peer-reviewed journals will adopt these standards.

The amended Principles include the following changes:

• A requirement that companies register all interventional clinical trials involving patients in a timely manner onto a public website. This increase in transparency will allow more patients to enroll in relevant and helpful studies.
• A commitment by companies to provide result summaries of safety and effectiveness of all interventional clinical trials involving patients, whether the drug has been approved or the trial has been discontinued.
• The adoption of the authorship standards of the International Committee of Medical Journal Articles (ICMJE), which will mean that only those who made significant contributions to the article will be credited as an author.
• Strengthening of disclosure standards for published research that companies sponsor by disclosure of financial or personal relationships that create a conflict of interest.

As we recently noted, Seton Hall Law’s Center for Health and Pharmaceutical Law & Policy recommended the type of transparency set forth in PhRMA’s revised Principles in its recently-released whitepaper.

We also recently blogged about the fall out from the nonpublished clinical studies of AstraZeneca’s antipsychotic drug, Seroquel.