Clinical trials applications FDA

When designing clinical trials,it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies,guidances,and regulations reflect decades of agency efforts to foster the participation of diverse patient populations in clinical trials,more work is required.

FDA is seeking your comments on this important public health issue. On Tuesday,April 1,2014,we’re holding a public hearing on the challenges of collecting and analyzing information on demographic subgroups—including sex,race,ethnicity and age—in clinical trials for FDA-regulated medical products.

We’re looking for ideas and viewpoints from our stakeholders—from clinical researchers,academia,industry,health care professionals and patient advocates. As director of FDA’s Office of Minority Health,I’m inviting you to attend this hearing in person or online,or tobefore or after the hearing on issues that are vital to you.

Your perspectives will be critical as we develop our FDA action plan for improving public health across all demographic groups. The action plan will include recommendations on ways to enhance the collection and analysis of information about the sex,race,ethnicity,and age of clinical trial participants in applications that medical product developers submit for FDA review and approval. We are also seeking ideas and views about how to improve the communication of crucial information on medical products to patients,health care professionals and researchers.

Recently,in Section 907 of the Food and Drug Administration Safety and Innovation Act of 2012,Congress asked FDA to produce a report on this topic and to follow it up with an action plan. In the development of the report,FDA carefully examined 72 product applications approved in 2011.

We determined that the statutes,regulations and policies we have in place generally give drug developers a sound framework for providing information in their applications on the inclusion and analysis of these demographic groups. We also found that medical product developers generally are describing the demographic profiles of their clinical trial participants,and most applications submitted to FDA include analyses of these demographics.

However,we recognize that more can be done. So,as part of the process of developing FDA’s action plan,we’re holding this public hearing to get your views on these and related issues. We can’t do this without your help,so we hope you’ll join us at the hearing in person or online on Tuesday,April 1!

Jonca Bull (2488 x 3738)

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Popular Q&A

How many clinical trials does the FDA require?

The Food and Drug Administration decides on how many and to what extent of clinical trial's are necessary depending on the drug or product being tested. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.

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