A fundamental change is under way in how the National Cancer Institute (NCI) develops, reviews, conducts, and supports clinical trials.

The revitalized system is more flexible and more inclusive, inviting input from basic and clinical researchers, community and research oncologists, patients and families, and all groups with a commitment to improving cancer care.

The new system will speed new ideas from lab to clinic, increase physician and patient participation, and streamline administration and data reporting.

Several pilot projects are under way, and several more will soon be launched. Like a puzzle, each piece is equally important, and each piece interconnects with the others.

The NCI's efforts to build the new clinical trials system fall into five categories: generating new ideas, broadening access for physicians and patients, educating and communicating, streamlining procedures, and automating data systems.

Why Revamp?

The overall goal of the new system is to accelerate the pace of clinical research, and therefore rapidly answer important research questions.

Increasing the number of patients on clinical trials is essential. While 20,000 cancer patients take part in NCI-sponsored clinical studies each year, many patients who would be eligible never have the opportunity and most do not know that a clinical trial may be a treatment option for them. In addition, barriers prevent many physicians from participating in clinical research. In the new system any qualified oncologist in the U.S. will be able to offer patients NCI-sponsored clinical trials.

For physicians who already participate in trials, paperwork and procedural workloads are being reduced by standardizing data collection and by online reporting systems. The process of informed consent is being simplified and projects are underway to centralize the Institutional Review Board (IRB) process.

To assure that promising treatment ideas move quickly from the lab into the clinic, the NCI is committed to stimulating and funding innovative approaches. New meeting forums are bringing together basic and clinical scientists from academia and industry, thus expanding the pool of research ideas, and a new scientific review process has been designed to ensure that the best ideas are evaluated in clinical trials.

Through these and other changes, the NCI and its partners will be able to streamline the national clinical trials system, which in turn will improve cancer care for everyone.

Background Information

Report of the National Cancer Institute Clinical Trials Program Review Group--Also known as the Armitage Report, this 1997 report from the NCI's Clinical Trials Program Review Group launched the planning for the new clinical trials system. Dr. James O. Armitage from the University of Nebraska served as the group's chair.

Clinical Trials Implementation Committee--This committee translated the Armitage Report's recommendations into a working plan. It was co-chaired by Dr. John Glick of the University of Pennsylvania and Dr. Michaele C. Christian of the NCI.

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