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ACCP Statement on Organ-Impaired Patients in Oncology Trials


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The American College of Clinical Pharmacology (ACCP) recently published a Policy Statement reviewing ways in which clinical pharmacology can and should make an effort to include organ-impaired patients in oncology trials. The announcement identifies key discussions needed among industry, regulators, and clinicians prior to the widespread adoption of expanded eligibility criteria for such trials.

The ACCP Policy Statement is a response and call for discussion based on recent recommendations put forth from a working group initiative that advises patients with renal and hepatic impairments to be enrolled into oncology clinical trials. These recommendations, which were generated from a collaboration among ASCO, Friends of Cancer Research, and the U.S. Food and Drug Administration, aim to increase patient participation in and real-world extrapolation of results from oncology studies.


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