New PhRMA database provides doctors and patients unprecedented access to clinical study information for marketed medicines
WASHINGTON, D.C., September 7, 2004 -- The pharmaceutical industry announced that it would inaugurate a central, easily accessible database to better communicate the results of clinical studies of marketed drugs.
The database, available at www.clinicalstudyresults.org, will contain the results of all controlled clinical trials (mainly Phase III and IV studies), both positive and negative, completed since October 2002 for PhRMA-member company drug products approved in the United States. This will include both published articles and unpublished study summaries. The free, comprehensive Internet database will be publicly available beginning October 1, 2004.
"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. This new database reflects the pharmaceutical industry's ongoing commitment to help educate practicing physicians and patients about marketed prescription medicines," said Alan F. Holmer, PhRMA president and CEO. "Doctors will now have centralized access to the important and meaningful information they need."
The online database is being established by the Pharmaceutical Research and Manufactures of America (PhRMA). PhRMA-member companies will be able to post information about their completed clinical trials to the database so that physicians, patients and others will have a central location to search for and review this important information.
"With the inauguration of this database, America's pharmaceutical companies continue their leadership role in making meaningful clinical trial results available to doctors and patients," said Caroline Loew, Ph.D. PhRMA Vice President for Scientific and Regulatory Affairs. "The database contains an unprecedented amount of easily accessible clinical trial information and will be a valuable resource to doctors seeking the latest information about a marketed medicine," added Dr. Loew.
The information in the database will be presented in a standard 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 center, 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 home page contains the search engine and links to general information on clinical trials. Search capabilities are broad. Key words include the drug name, company name, disease state, indication, study name, and study name.
The Pharmaceutical Research and Manufacturers of America represents the country's leading pharmaceutical research and biotechnology companies.Source: PhRMA www.phrma.org
Posted: September 2004