IOM on cancer trials
This article was originally published in The Gray Sheet
Executive Summary
The National Cancer Institute should coordinate with FDA on the review and oversight of new device and drug trials "to eliminate iterative review steps" and FDA should follow through on plans to establish a coordinated cancer program to avoid conflicting review requirements for cancer combination products, the Institute of Medicine recommends in its April 15 1report on the U.S. cancer clinical trial system. IOM also urges enhanced use of biomarkers in clinical trial protocols. The report was developed at the request of NCI to outline an approach to reforming the cancer clinical trials infrastructure. It includes four broad-based recommendations: to improve the speed and efficiency of the design, launch and conduct of trials; to better incorporate innovative science into trials; to improve the process for prioritizing and funding trials; and to increase patient and physician participation