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. 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 reporting requirement mandated by Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA Section 801).
In general, FDAAA Section 801 expands the scope of trials and information required to be submitted to ClinicalTrials.gov (a service of the U.S. National Institutes of Health, NIH). In accordance with FDAAA Section 801, Amylin will post basic results data from applicable clinical trials subject to Food and Drug Administration (FDA) oversight, on ClinicalTrials.gov.
Additional 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.
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.