FDA involvement in clinical trials.

The US Food and Drug Administration (FDA) was established to protect, promote, and advance public health, and to provide the public with accurate scientific information. This broad mission applies to products that impact almost every aspect of our daily lives, including human drugs and their development. While the FDA does not sponsor or conduct clinical trials, its responsibilities to the public require it to play a critical role in the clinical research process.

What follows are some examples of how the FDA’s work impacts clinical trials:

  1. Before any clinical research in humans can begin, the sponsor is required to submit an Investigational New Drug (IND) application to the FDA. The application includes comprehensive records of past study data and results, the sponsor, the manufacturing information, the drug, and the protocol. An FDA review team, comprising a medical officer, statistician, and several scientists, assesses the IND to ensure that the investigators are qualified and that participants aren’t being misled or exposed to significant or unnecessary risks. The FDA must approve the IND or the research will be placed on hold until all issues have been resolved. This review process is repeated each time the investigational product is tested until the sponsor decides to submit a marketing application.
  2. FDA expedited review programs (Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations) were developed to ease the burden of development and to speed up the review process for new treatments for serious or life-threatening conditions. While the individual programs have specific guidelines and requirements, the FDA pushes new drugs and current drugs for new uses from the trial phase to market quicker.
  3. The FDA Amendments Act of 2007 (FDAAA) required the creation of a registry for clinical trials. In collaboration with the National Institutes of Health, gov was developed. This serves as a registry and results database for most publicly and privately funded research in the United States. Consumers, patients, loved ones, healthcare professionals, and researchers can easily access information regarding specific trials, their interventions, the sponsor, the investigators, and the results once the study has concluded.

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