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cancer research

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Compliance in Early-Phase Cancer Clinical Trials Research

Compliance in Early-Phase Cancer Clinical Trials Research

March 1, 2013Written by David J Stewart, Razelle Kurzrockin Articles

ABSTRACT Regulations and ethical principles require that investigators seek consent and that patients participate in experimental studies only under circumstances that minimize the possibility of undue pressure and/or enticements. In recent years, there has been a rapid rise in the monitoring requirements of early-phase trials accompanied by an increasing emphasis on assuring “investigator” compliance with the protocol. It is actually, however, the patient who must comply with the requirements of the study. If there is divergence from the protocol, investigators may be reported to regulatory bodies or agencies. Whereas the…

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Equipoise Lost: Ethics, Costs, and the Regulation of Cancer Clinical Research

Equipoise Lost: Ethics, Costs, and the Regulation of Cancer Clinical Research

June 10, 2010Written by David J Stewart, Razelle Kurzrock, Simon N. Whitneyin Articles

ABSTRACT Cancer is the leading cause of death in Americans younger than 85 years of age and kills one American every 56 seconds. Advances in understanding of cancer biology have given us the potential to develop new, effective targeted therapies. However, progress is slowed by suboptimal/outdated clinical trial design paradigms and by regulatory complexity and rigidity. For instance, simulations suggest that restricting randomized trials to patients expressing drug target, instead of using unselected patient populations, could substantially reduce patient numbers required to demonstrate efficacy. High response rates that are achievable…

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