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FDA Encourages Collaborative and Innovative Approach to Clinical Trial Designs

December 30, 2021

The U.S. Food and Drug Administration's (FDA) Oncology Center of Excellence announced a series of efforts to design more efficient clinical trials. According to the FDA, "designing more efficient trials that produce better results can dramatically accelerate how quickly new therapies are brought to patients, and decrease the cost of doing so."

Some of the proposed efforts include:

  • working with stakeholders across government and the industry to modify the eligibility criteria for clinical trials, which could expand the number of people who qualify, open new opportunities for participation, and enhance the generalizability of the outcomes
  • shifting away from the conventional phase I, II, and III drug development paradigm to a more seamless approach that could expedite the regulatory pathway and provide earlier access to highly effective therapeutic drugs
  • using common control trials to decrease the overall number of patients needed for recruitment and enrollment, optimize clinical trial resources, and potentially decrease the time it takes to launch a new study
  • encouraging the use of large simple trials, which generally use easily measured endpoints that are well understood, thus optimizing the collection of data for safety or secondary efficacy endpoints and reducing the amount of data needed compared to conventional randomized trials

This effort is part of the Cancer Moonshot Initiative, led by Vice President Joseph Biden, which seeks to simplify the process for patients to find and enter clinical trials as part of the overall program goal. "Right now, less than 5 percent of cancer patients enroll in a clinical trial, often because patients and doctors don't know what trials are available," said Vice President Biden.

In addition, the National Institutes of Health (NIH) announced that it is interested in making more user friendly. Investigators will also be required to publish summaries of trial results whether or not they resulted in a drug approval. "This will enhance transparency within the clinical trials enterprise, allowing people to make more informed decisions about participating in research," according to a statement from NIH.

Sources: U.S. Food and Drug Administration news release, September 16, 2016; Reuters, September 16, 2016.


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