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Making Cancer Clinical Trials Available to More Patients

(NCI/Cancer Currents Blog) Mar 7, 2019 - Over the past several years, NCI has made efforts to address the issue of trial eligibility by working to broaden the criteria for some NCI-funded trials.

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Debu Tripathy, MD (Posted: March 09, 2019)

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Criteria for clinical trials sometimes occupy several pages of a protocol, underscoring how selective they can be by excluding certain age groups, or those with decreased organ function. While some of these may be important for safety reasons, many times they are overly burdensome, especially for when they are intended for patients with refractory cancers who might be expected to have some limitations or physiologic abnormalities. When a new drug is approved, we are finding that the studies upon which the approval was based are so stringent in their eligibility, that "real-world" cohorts or registries must be studied, adding cost and delays in our understanding to true benefit and risk balance of a drug. Efforts to make trials more streamlined and reflective of the target population are welcome.

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