Clinical Study Results Database Frequently Asked Questions The pharmaceutical industry has developed an online clearinghouse to provide greater access to the results of its clinical studies. The new database will enable interested physicians to find comprehensive scientific information about the medicines they prescribe. Why is the industry now developing a Clinical Study Results Database? PhRMA member companies have a long-standing commitment to providing patients, physicians and others with meaningful information about the medicines they develop. In addition to PhRMA’s 2002 Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results ( the Principles), the industry is expanding its efforts to increase the transparency of its clinical study (clinical trial) results. By creating a single, comprehensive database of clinical study results, physicians have a one-stop shop to find information about marketed drug products. What information will the Clinical Study Results Database include? The database will include a bibliography of and links (where available) to published articles reporting clinical study results as well as summaries of the results of clinical studies that have not been published. This format will provide the most utility to physicians seeking clinical study result information. What is meant by “meaningful results of controlled clinical trials”? The reference to “meaningful results of controlled clinical trials” in the PhRMA Principles is intended to refer to hypothesis-testing studies and to distinguish such trials from those that are merely exploratory in nature. Hypothesis-testing trials typically are the most rigorously conducted clinical studies and include all phase III studies, some earlier phase trials, and many studies of marketed products. Hypothesis-testing studies, by definition and design, always provide “meaningful results.” Why does the database not include phase I or phase II information? Many phase I and phase II studies will not be included in the database because they are not “hypothesis testing” but rather are exploratory in nature. These early-phase or post-marketing studies provide only preliminary information about a disease, condition or product and thus serve primarily to generate hypotheses for future clinical studies. Due to their limited statistical power, the database typically would not include information about these types of exploratory studies. It is important to note, however, that if significant safety issues are identified in phase I or phase II studies, this information is required to be submitted to the Food and Drug Administration (FDA) and would result in appropriate changes to the drug labeling to ensure safe use. Why won’t companies include all raw data from the clinical studies? PhRMA’s goal is to provide scientific information in a format that is useful to practicing physicians. Raw data from clinical studies is often thousands of pages long. To make the database a clearinghouse of information truly useful to physicians, it is important that physicians have access to result summaries, both positive and negative. Will the Clinical Study Results Database be useful for patients? Patients can and may look up the summaries of clinical studies, but the database is designed specifically for physicians seeking the latest information about a drug product. The information in the database will be scientific in nature and directed toward those with medical and health care backgrounds. Patients should remember to always use a prescribed drug product in accordance with their physicians’ instructions. Since this is a voluntary database, how will PhRMA ensure member company participation? The database is voluntary, but PhRMA’s board of directors — the leaders of America’s pharmaceutical companies — agreed that member companies will participate in and support the database and, as with PhRMA’s 2002 Principles, communicate all meaningful results, both positive and negative.