PhRMA Clinical Study Results Database What is the Clinical Study Results Database? It is a central, widely accessible, web-based repository for clinical study results in a reader-friendly, standardized format. This database (www.clinicalstudyresults.org) will serve the valuable function of making clinical study results for U.S.-marketed pharmaceuticals more transparent. It is important to note that these results are being made available to practicing physicians, patients and others for informational purposes only in the interests of full scientific disclosure and are not intended to substitute for the Food and Drug Administration(FDA)-approved labeling. What will the Clinical Study Results Database contain? The database will contain the results from all “hypothesis-testing” clinical studies (mainly phase III and IV studies) completed since October 1, 2002, for drug products that are approved in the United States. This will include both published articles and unpublished study summaries. This information 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(s), a bibliography of published studies together with a link (where available) to the printed articles, and a summary of the results of clinical studies that have not been published. This summary presentation will include information on the drug such as the design of the trial, the number of patients studied, the dose and mode of administration, and a summary of conclusions and outcomes on the safety and efficacy of the drug. What format will be used for the summaries? The study results will be posted in a standard format, accepted by regulators in the U.S., Europe, and Japan. The synopsis provides an easy-to-use template for conveying study information. Will the drug’s full prescribing information be available on the Website? Since the database is designed for informational purposes only and is not a substitute for FDA approval, the Website will provide a link to the most current FDA-approved prescribing information for the drug in question, where available, or will otherwise direct users to consult the FDA-approved prescribing information. How is clinical study information going to be added to the database? Member companies will register and have secure access to post their own data in an easy-to- use format. How can I access the Clinical Study Results Database? This publicly available, free-access database can be found at www.clinicalstudyresults.org. The homepage is an information resource as well as a database, containing a search engine and links to general information on clinical studies. The search capabilities are broad, and key words include the drug name (proprietary and generic), company name, studied indication, study name, and study phase. How will the database operate? PhRMA will initially establish the electronic database to ensure that it is fully operational as of October 1, 2004. PhRMA hopes that database administration will eventually be transferred to an independent third party. How often will it be updated? Updating the database will vary depending on the type of study. References to scientific papers will be posted when they are published. In accordance with FDA’s annual report regulations, PhRMA will urge companies to post unpublished study summaries within one year of completion.