Journal of Clinical Oncology, Vol 15, 2736-2743, Copyright © 1997 by American Society of Clinical Oncology
Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute
MA Smith, RS Ungerleider, EL Korn, L Rubinstein and R Simon
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD 20892, USA. smithm@ctep.nci.nih.gov
PURPOSE: To describe the rationale for independent data monitoring
committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III
cooperative group clinical trials. DESIGN: We review the necessity for
interim monitoring of outcome data during the course of randomized clinical
trials and summarize the reasons for establishing DMCs with requisite
expertise and with appropriate independence from study investigators.
RESULTS: The important components of the policy for cooperative group DMCs
are described with a focus on the makeup of these bodies and on the
complementary roles of study committee leadership and DMCs in protecting
patient safety during the conduct of randomized clinical trials.
CONCLUSION: The cooperative group DMCs that are independent of the study
committees and that have the requisite expertise to examine accumulating
data and to base decisions on monitoring guidelines that are specified in
advance by the study committee provide a body able to protect patient
safety, to protect the integrity of the clinical experiments on which
patients have consented to participate, and to assure the public that
conflicts of interest do not compromise either patient safety or trial
integrity.
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