The timely posting on a public website of all interventional clinical trials involving patients is one of the key changes being advocated by the Pharmaceutical Research and Manufacturers of America industry group in new guidelines. Among websites up to the task: the U.S. National Library of Medicine's www.clinicaltrials.gov.
The PhRMA board of directors unanimously endorsed measures that strengthen its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results as part of an ongoing effort "to help ensure objectivity and enhance transparency in clinical research," according to an announcement. The document was last updated in 2004.
"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, in the announcement. "But we've heard the calls that we could do more. These revised principles further renew our pledge to practice what we preach."
The revised principles take effect October 1, 2009. Among other changes, the principles also call for investigators to provide results summaries for all interventional clinical trials involving patients, whether the medicines are approved or the programs are discontinued.
- see the Principles
- here's the announcement for more