The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials. 2015 Sep 15; Authors: Anderson ML, Griffin J, Goldkind SF, Zeitler EP, Wing L, Al-Khatib SM, Sherman RE Abstract Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable Food and Drug Administration regulations. While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board. We are concerned that current Food and Drug Administration requirements for o...
Source: Clinical Trials - Category: Research Authors: Tags: Clin Trials Source Type: research