The Years of Creativity: 1953-1965. Cooperative Oncology Groups and Clinical Trials

Abstract

Cooperative oncology groups were formed by the Cancer Chemotherapy National Service Center to test on humans promising chemotherapeutic drugs that were coming through the screening program. Patients from several institutions were pooled to shorten the time required to test new compounds against various malignancies, establish standards and objective criteria for diagnosis, patient selection, treatment and measurement of effect, and ensure statistically valid study designs and data analyses. The different phases of clinical investigation of malignant tumors were created: Phase I to establish the maximal tolerated dose of the new agent, its toxicity and pattern of reversibility; Phase II to look for activity in a broad spectrum of malignancies, which required the elaboration of objective criteria for therapeutic response; and Phase III to determine the efficacy and safety of the new drug in the specific cancer sites where activity had been observed in a Phase II study.

Keywords: Cooperative oncology groups, Phase I, Phase II, Phase III.

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