US Pharma create one-stop shop for medicine info
central, accessible database to improve the communication of the
clinical study results of marketed drugs.
The database will contain the results of all controlled clinical trials (mainly phase III and IV studies) and is to include both positive and negative data, completed since October 2002 for Pharmaceutical Research and Manufacturers of America (PhRMA) member company drug products approved in the United States.
The move comes after concerns that doctors and patients did not have access to information about failed drug trials, which prompted leading journal editors to call for a database of company trials in June this year.
The International Committee of Medical Journal Editors, which includes The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and the Annals of Internal Medicine within its ranks, put pressure on the drug companies to be more open about the clinical trials they conducted.
The claims that GlaxoSmithKline (GSK) suppressed negative results of its antidepressant drug Paxil (paroxetine), added to the motivation for drug companies to join a proposed registry.
"Two years ago, the pharmaceutical industry committed to communicating meaningful results of clinical studies, regardless of outcome, by adopting the PhRMA Principles for the Conduct of Clinical Trials and Communication of Clinical Trial Results," said Alan F. Holmer, PhRMA president and CEO.
"Doctors will now have centralised access to the important and meaningful information they need."
The information in the database will be presented in a format that includes the sponsoring company's name, the proprietary and generic names of the drug, a link or reference to the FDA-approved drug label, the studied indication or disease, a bibliography of published studies together with a link (where available) to the printed articles, and a standardized summary of unpublished studies.
The standardized summary includes information about the study centre, the design of the trial, the number of patients studied, the dose and mode of administration, and a summary of conclusions and outcomes, whether positive or inconclusive.
The database is expected to include a search engine and links to general information on clinical trials. Search capabilities include drug name, company name, disease state, indication, and study name.
The free comprehensive database will be publicly available on October 1 at http://www.clinicalstudyresults.org.
