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FDA issues final guidances for clinical cancer trials

The FDA is working to address inequities, target the right treatments to the right patients and speed progress against the most deadly and rare cancers


The US Food and Drug Administration (FDA) has issued three final guidances regarding clinical cancer trials, channelling the goals of US President Biden’s recently revealed efforts to renew and build on his 2016 initiative – Cancer Moonshot – which promises to facilitate further advancement in cancer prevention, detection, research and patient care.

Inspired by medical advancements in the field since 2016, the president’s new goals for this iteration are to reduce the death rate from cancer by at least 50% over the next 25 years, and to improve the experience of people and their families living with and surviving cancer.

The first guidance, Inclusion of Older Adults in Cancer Clinical Trials, gives recommendations to sponsors and institutional review panels for including patients aged 65 and older in clinical trials for cancer treatments.

The recommendation includes – if appropriate – enrolling older adults in early phase studies of cancer clinical trials to gain information for future studies. Additionally, it includes recommendations for recruitment strategies, trial design, information collection and developing more discrete age brackets in order to encourage enrolment of a part of the population that has historically been excluded.

The second guidance for industry is Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics, which provides advice on designing and conducting trials with multiple expansion groups. Researchers and pharmaceutical companies can use trials with expansion cohort design to evaluate various aspects of a drug in a single clinical trial to efficiently action the clinical development of the drug.

Lastly, the third guidance for industry is Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics, which addresses master protocol design, including information on what sponsors should submit to the FDA as part of trial design approaches and directs sponsors on how to interact with the FDA to facilitate an accelerated review, while mitigating risks to patients.

Richard Pazdur, director for the FDA’s Oncology Center for Excellence, highlighted that, in issuing its latest guidance measures, the FDA is “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”.

Article by
Fleur Jeffries

3rd March 2022

From: Regulatory



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