Revised Clinical Trial Principles Reinforce PhRMA's Commitment To Transparency and Strengthen Authorship Standards

Revised Clinical Trial Principles Reinforce PhRMA's Commitment To Transparency and Strengthen Authorship Standards

Washington, D.C. (April 20, 2009) - Reflecting the continued commitment of America's pharmaceutical research and biotechnology companies to encourage practices that best serve the needs of patients and the healthcare community, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors have unanimously endorsed measures that strengthen PhRMA's Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.

The newly revised PhRMA Principles, which build on improvements already made in the 2004 revision, are part of an ongoing effort to help ensure objectivity in research and enhance transparency in clinical research.

"Our member companies have a longstanding commitment to ethical conduct of clinical trials and to transparency in reporting," said Billy Tauzin, PhRMA President and CEO.

"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," Tauzin added.

The PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (read the report), which take effect on October 1, 2009, 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.

Among its changes, the revised Principles:

• Increase transparency by committing companies to the timely registration of all interventional clinical trials involving patients - including some early Phase 1 studies - on a public website, to help patients who need medical care enroll in relevant studies. There are important public health benefits associated with making appropriate clinical trial information widely available to healthcare practitioners, patients and others. The most important clinical trials are those that test a medicine in patients -people who actually require medical care. Results of these trials provide medical evidence regarding the safety and effectiveness of medicines in the precise population the medicine is intended to help.
• Greatly expand transparency in medical research by committing to provide results summaries for all interventional clinical trials involving patients - regardless of whether the medicines are approved or the particular research programs have been discontinued. By providing results summaries of safety and effectiveness data for clinical trials shortly after a drug's approval or discontinuation of development, PhRMA members will significantly expand the universe of publicly available data about clinical trials in patients.
• Move in lockstep with medical journal editors by adopting the authorship standards of the International Committee of Medical Journal Editors (ICMJE). Under these revised Principles, only individuals who make substantial contributions to medical manuscripts will be recognized as authors.
• Enhance disclosure standards for published research that companies sponsor by also aligning with ICMJE standards regarding disclosure in medical journal manuscripts of all financial or personal relationships that might present a conflict of interest - whether in an article or a letter. What's more, authors of medical journal manuscripts should describe the role of sponsors in designing the study, collecting and interpreting data, and writing the report.

In addition, the revisions announced today bring the Principles regarding company-sponsored clinical trial investigator meetings in line with the revised PhRMA Code on Interactions With Healthcare Professionals, which went into effect January 2009.