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New Clinical Trial Guidance for the Development of Cancer Treatment

The new guidance will help target treatments and address inequities by including all patients

On March 1, 2022, the U.S. Food and Drug Administration issued new guidance regarding cancer clinical trials. Cancer is the second leading cause of death in the United States, with more than 600,000 cancer deaths in 2020. The three new guidances from the FDA support the goals of the Biden Administration’s efforts to build upon the 2016 Cancer Moonshot initiative, which now seeks to reduce the cancer death rate by 50 percent within the next 25 years.

The first guidance provides recommendations for the inclusion of patients who are 65 years and older in cancer drug trials. Specifically, it encourages the enrollment of older adults in early phase studies to better inform later phases. It also provides recommendations for recruitment, trial design, and information collection. Improving recruitment of older adults in clinical trials is vital to highlight potential variations between age groups with regards to drug response.

The second guidance advises clinical researchers on designing and conducting trials with multiple expansion cohorts. This can allow for the assessment of many different aspects of a drug in a single clinical trial, expediting its development.

The final guidance addresses master protocol design and advises sponsors on what should be submitted to the FDA. It also provides guidance on how sponsors can interact with the FDA to minimize patient risk and improve review efficiency. 

“With today’s actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients,” said Richard Pazdur, MD, director of the FDA’s Oncology Center for Excellence. “All of these are tenets of Cancer Moonshot’s mission.”