FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16

On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population. Meeting The public meeting will be held at the National Press Club, 529 14th St. NW, Washington, DC 20045. For additional travel and hotel information, please refer to the following website. There will also be a live webcast for those unable to attend the meeting in person. For further information, contact Dianne Paraoan at the FDA’s Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-2500, Dianne.Paraoan@fda.hhs.gov. Topics for discussion during this meeting include: The risks and benefits of participation in clinical trials as well as potential regulatory, geographical, and socioeconomic barriers to participation. The rationale for eligibility criteria in clinical trials, as well as the impact of exclusion criteria on the enrollment of populations, such as infants, childr...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs