Pharmaceutical industry issues its plan for voluntary clinical trials registry.(Practice Trends)

In the face of bad publicity and impending restrictions, trade groups representing pharmaceutical companies have proposed a voluntary plan for using a clinical trials registry as well as results databases by midyear.

The "Joint Position on the Disclosure of Clinical Trial Information via Clinical Trials Registries and Databases," issued by the Pharmaceutical Research and Manufacturers of America (PhRMA), sister organizations in Europe and Japan, and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) covers all nonexploratory (non-phase I) clinical drug trials and has two major requirements:

1. Clinical trials registry listing. All trials initiated on or after July 1, 2005, must be included in a clinical trials registry. Trials that are now underway must be included by Sept. 13, 2005.

Each trial "should be given a unique identifier to ensure transparency of clinical trial results" that would permit tracking the trial results through multiple databases. The U.S. government's trial registry site (www.clinicaltrials.gov) was specifically promoted as an acceptable registry model.

2. Timely posting of results. Results for all trials completed after Jan. 6, 2005, must be posted in a timely manner, generally within 1 year after the drug is first approved and commercially available in any country, or, for trials completed after approval, within 1 year of trial completion. An exception is made if posting would compromise publication in a peer-reviewed journal.

The database should include results of all non-phase I trials "conducted on a drug that is approved for marketing and is commercially available in at least one country," according to the proposal. Furthermore, the data must be disclosed "on a free, publicly accessible, clinical trials database, regardless of outcome."

The deadlines for registration outlined in the proposal match the mandatory deadlines issued by the International Committee of Medical Journal Editors last September. The ICMJE will require clinical trials registration prior to publication of drug trial results in member journals (including the Journal of the American Medical Association and the New England Journal of Medicine).