PhRMA makes Phase 1 human studies registration mandatory

All  human studies for drugs should be registered in public websites from 1 Oct, 2009: PhRMA.

Now pharma companies will have to register all the human studies, including the limited first-in-man or Phase 1 studies, on public Web sites.

Drug makers will have to register some Phase 1 clinical trials on public web sites, if the trial involves human subjects with the disease or condition being studied, according to the new Clinical Trial Conduct and Reporting Policy by Pharmaceutical Research and Manufacturers of America (PhRMA).

PhRMA –the umbrella body of the largest drug makers –announced the revision of its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results at the National Institutes of Health’s (NIH’s) April 20 public meeting on the expansion of ClinicalTrials.gov.

“PhRMA members will register all clinical trials in patients including some early Phase 1 clinical trials,” Jeffrey Francer, PhRMA assistant general council, said at the public hearing.

The revised principles on clinical trial conduct will take effect from 1 Oct. 2009. The new conduct guidelines also call for companies to provide result summaries for interventional clinical trials involving patients for approved medicines as well as those medicine’s whose research programs are discontinued.

“Going forward, PhRMA members will provide summaries of safety and effectiveness data for clinical trials in patients whenever drug development is discontinued,” Francer said.

PhRMA, however, hoped that NIH would help its members to post voluntarily on ClinicalTrials.gov information on early stage clinical trials in a way that would not threaten the viability of future research, he said.

Announcing the revisions, PhRMA was“moving in lockstep with medical journal editors by adopting the authorship standards of the International Committee of Medical Journal Editors (ICMJE).”

According to revised principles state that when authors submit a manuscript to a medical journal, whether an article or a letter, they are responsible for disclosing all financial and personal relationships that might bias their work.

To prevent ambiguity, authors should state explicitly whether potential conflicts do or do not exist. Authors also are expected to identify individuals who provide writing or other assistance and disclose the funding source for this assistance.

“Under these revised principles, only individuals who make substantial contributions to medical manuscripts will be recognized as authors,” PhRMA said.

More on the revised policy would appear be in the June issue of the Guide To Good Clinical Practice newsletter, PhRMA stated.