NCI Publishes Guidelines for Design of Phase I and Phase II Clinical Trials

2010-06-01

The National Cancer Institute’s (NCI) Investigational Drug Steering Committee (IDSC) provides broad external scientific and clinical input on the design and prioritization of early-phase clinical trials with agents for which the NCI Cancer Therapy Evaluation Program (CTEP) holds an Investigational New Drug (IND) application.

The IDSC has formed a number of task forces and working groups, including the Clinical Trial Design Task Force, the Biomarkers Task Force, and the Angiogenesis Task Force. Task force members include NCI staff, grantees, contractors, and others from academia, the pharmaceutical industry, and regulatory authorities.

The Clinical Trials Design Task Force sponsored a workshop on phase I and phase II clinical trials, with the primary goal of developing consensus recommendations for the optimal design of these studies, including efficient trial designs, phase I drug combinations, and appropriate statistical and correlative endpoints (in conjunction with the Biomarkers Task Force). Articles summarizing key considerations and recommendations were published in the Focus section of the March 10, 2009, and March 15, 2010, issues of Clinical Cancer Research.

A subcommittee of the Angiogenesis Task Force convened an interdisciplinary cardiovascular toxicities expert panel to evaluate the hypertension associated with drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway (VSP). The panel reviewed the published literature on blood pressure, hypertension, and specific VSP inhibitors, abstracts from major meetings, shared experience with development of VSP inhibitors, and established principles of hypertension care. Their recommendations on an approach for safe management by treating physicians to allow the greatest possible number of patients to receive VSP inhibitors safely was published in the May issue of the Journal of the National Cancer Institute.

Published summaries and recommendations from these workshops are listed below.

References

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  5. Ivy SP, et al. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010;16(6):1726-36.
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