ACC Shares Expertise During FDA Meeting on Data Collection and Analysis
Recently the Food and Drug Administration (FDA) held a public meeting to discuss methods for increasing the collection, analysis and communication of information from clinical trials pertaining to demographic subpopulations. Speaking on behalf of the ACC, E. Magnus Ohman, MD, FACC, discussed the importance of capturing the effects of new therapies on the elderly, women, and racial and ethnic minorities, particularly for the development of clinical guidelines. Ohman explained that when clinical trials fail to collect such information, the guidelines are not able to provide the necessary information to cardiologists and their patients, hindering their ability to appropriately weigh treatment options. He also expressed the College's commitment to the development and maintenance of registries, which capture the real-world experiences of cardiovascular patients, regardless of their age, sex or racial/ethnic background. Ohman also urged the FDA to approve clinical trials "focused on answering the broader question of how a particular therapy would work in the population that frequently has the disease, rather than targeting them to only focus on gaining approval." The FDA will continue collecting written comments from the public through May 16 and the ACC intends to submit more detailed comments at that time.
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