Clinical Trials
Amylin’s Commitment to Disclosure of Clinical Trial Information
Amylin believes that meaningful results of our hypothesis-testing1 clinical trials for marketed products, whether positive or negative, should be made available to the public, and we recognize that the timely availability of these results is critical to communicate important new information to health professionals, patients, family members and the public. As such, Amylin adheres to the intent and spirit of the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results which places great importance on the accessibility of clinical trial information. To facilitate posting of such information, PhRMA provides a web page at www.clinicalstudyresults.org, dedicated solely to clinical trial results. In accordance with PhRMA’s principles, Amylin will post meaningful results of its hypothesis-testing Phase 2, 3, and 4 clinical trials completed after October 1, 2002, for all of our products approved by the Food and Drug Administration (FDA), on the PhRMA web site. Communication of clinical trial results may also include publication of a manuscript in a peer-reviewed2 medical journal, abstract submission with a poster or oral presentation at a scientific meeting, or by other means of disclosure.
Furthermore, Amylin posts information about ongoing clinical trials on a government-mandated web page at www.clinicaltrials.gov, which is a National Institutes of Health registry of ongoing trials that are open and intended for patients with serious or life-threatening diseases. Registration of these trials in this registry is required by law. In addition, we register all of our ongoing phase 2, 3, and 4 hypothesis-testing clinical trials, regardless of whether they are intended to treat serious or life-threatening illnesses or conditions.
Statements about clinical trials that have not yet begun or that are ongoing are intended solely to provide information about eligibility and enrollment to potential volunteers. Generally, the products being studied in these clinical trials are not approved for prescription by healthcare professionals for their patients. A listing in a clinical trial registry does not mean that the drug used in the trial is safe or that the drug will be effective. Listing is purely informational about enrollment and not intended to be promotional in any way. A decision about whether to seek enrollment in a clinical trial should be done only after consideration of all available information, including the potential risks associated with the use of a clinical study drug and, when appropriate, consultation with a health care professional.
Statements about results of completed clinical trials for approved products are scientific summaries about specific study results and do not alone represent the basis for approval by the FDA. FDA drug approval is based on an analysis of all available information and data related to a drug product’s safety and efficacy. A listing of specific study results by Amylin for an FDA approved product is not intended to be a promotional claim and should not be solely relied upon to make healthcare decisions. Decisions by healthcare providers about whether to prescribe any prescription drug product should be done only after consideration of an FDA approved package labeling in conjunction with all available data and other information.
1 “ Hypothesis–testing ” trials (also known as confirmatory clinical trials) are always well-controlled and are intended to provide meaningful results by examining pre-stated questions (i.e., hypotheses) using predefined statistically valid plans for data analysis.
2 “ Peer review ” is a scholarly process used in the publication of manuscripts and in the awarding of funding for research. Publishers and funding agencies use peer review to select and to screen submissions. Peer review subjects an author's work or ideas to the scrutiny of one or more others who are experts in the field. These referees each return an evaluation of the work, including suggestions for improvement. Publications and awards that have not undergone peer review are likely to be regarded with suspicion by scholars and professionals in many fields.