Organizing multicenter trials: lessons from the cooperative oncology groups

Area of Science:

• Oncology
• Clinical Trials
• Cancer Prevention

Background:

• Cancer clinical therapy trials have a well-established infrastructure within Clinical Oncology Groups (COGs).
• Cancer prevention trials differ significantly, being larger, longer, and facing challenges with participant compliance, toxicity, and cost.
• Current medical practice is geared towards treating sick patients, not recruiting healthy volunteers for prevention studies.

Purpose of the Study:

• To explore potential roles for Clinical Oncology Groups in cancer prevention research.
• To leverage the existing infrastructure and expertise of COGs to overcome challenges in prevention trials.
• To identify specific populations and trial designs where COGs can contribute effectively to chemoprevention.

Main Methods:

• The study reviews the established operational model of COGs, exemplified by the Eastern Cooperative Oncology Group.
• It proposes analogous roles for COGs in prevention research, drawing parallels with Phase 1 trials for safety and toxicity testing.
• It identifies key populations for recruitment: individuals at high risk for second cancers and relatives of cancer patients.

Main Results:

• COGs can conduct preliminary safety and toxicity testing of cancer prevention agents.
• COGs can recruit high-risk individuals, including those at risk for second cancers, into prevention trials.
• COGs can leverage their resources to recruit motivated participants, such as cancer patient relatives, for prevention studies.

Conclusions:

• Clinical Oncology Groups possess the trial discipline and infrastructure to significantly facilitate cancer prevention research, particularly chemoprevention.
• While not primary drivers, COGs can play crucial supporting roles in agent testing and participant recruitment.
• Adapting COG mechanisms could enhance the efficiency and success rate of cancer prevention trials.