Imagine a comprehensive IT system, collecting standardized clinical trial data including volunteer information and outcomes. It's hardly a revolutionary idea, until you try to apply it across the half-century-old infrastructure in use by the 14,000 investigators registered to participate in the National Cancer Institute's cooperative group studies.
Such an IT system is at the core of an ambitious plan to speed up cancer drug development. NCI aims to revamp its 55-year-old Clinical Trials Cooperative Group Program for nationwide trials by creating four integrated groups from the current nine. The four groups will design and perform improved trials of cancer therapies. "The aim is not just fewer groups, but rather groups that function in a more closely integrated manner," says James Doroshow, director at NCI's Division of Cancer Treatment and Diagnosis, in a press briefing.
"We want very much to facilitate the transition of investigations in the early phase to larger trials--multi-site randomized phase II studies, to really test scientific questions, He says. "The future is one in which the bar is set higher to get to a Phase III trial. We're going to demand more scientific information that will necessitate more correlative science being done at the point of, say, the first 200-patient randomized Phase II investigation."
IT specifics are few at this point. NCI has more of a sketch of its needs, based on findings in a report it commissioned from the Institute of Medicine that was published in April. The report, which describes the current situation as "inefficient, cumbersome, underfunded, and overly complex," calls for consolidation of back-office administration and data management operations of the cooperative groups in conjunction with their restructuring.
The back-office operations encompass such activities as data collection and management, data queries and reviews to ensure data accuracy, patient registration, audit functions, processing of case report forms, training, image storage and retrieval, drug distribution, and site credentialing.
- see the NCI release
- here's the hour-long briefing replay