Director's Update: April 13, 2004

CIRB to Be Extended to Support Pediatric Trials

The annual spring meeting of the Children's Oncology Group (COG) was held in Washington, D.C., earlier this month, and I had the privilege of learning about some of the exciting work that COG researchers are currently conducting. Representative Bill Young (R-Fla.) and I had the honor of addressing the membership during its March 31 luncheon, when Rep. Young received the organization's Congressional Champion for Childhood Cancer Award in recognition of his pivotal role as Chair of the House Appropriations Committee and his leadership in supporting COG's research program to identify more effective treatments for children with cancer.

COG is a National Cancer Institute-supported clinical trials cooperative group devoted to translational and clinical research on childhood and adolescent cancers. It develops and coordinates clinical trials conducted through its 238 member institutions, which include cancer centers in the United States, Canada, Europe, and Australia. COG enrolls approximately 4,000 children and adolescents in treatment studies annually and has 70-80 studies open to patient accrual each year.

COG's primary objectives are to define optimal treatments for children and adolescents with cancer through clinical trials; support and perform research into the etiology and biology of childhood cancers that will translate into more effective treatments; improve patients' quality of life and ensure patient access to the most advanced treatments available; and finally, share findings among member institutions and the larger cancer community to accelerate the search for cures for all major types of childhood cancer.

COG and NCI recently announced the establishment of a Pediatric Central Institutional Review Board (PedCIRB). Led by Dr. Gregory H. Reaman, COG conducted a survey of its member institutions and found a high level of support for a pediatric central IRB. NCI responded to this interest by agreeing to include pediatric protocols within NCI's Central IRB (CIRB) Initiative. PedCIRB will provide for quality review of protocols by utilizing the childhood cancer expertise available through a national IRB and will improve access to phase II and III clinical trials for children and adolescents with cancer. These priorities are fully congruent with those of the CIRB Initiative being led by NCI's Cancer Therapy Evaluation Program.

The CIRB concept has encountered some resistance in the adult clinical research community. Primarily, the slower adoption is a consequence of the reluctance of local IRBs to relinquish the responsibility they hold for reviewing patient safety within their own institutions and perceived indemnification issues related to central review. The CIRB Initiative aims to provide consistent standards for safeguarding the welfare of human research subjects, improve patient and physician access to clinical trials, and give participating institutions access to a "facilitated review process," thereby reducing local administrative burdens. The difficulties local IRBs have faced in shouldering the weight of administrative and regulatory demands on their own are known to constitute a barrier to the swift and efficient initiation and completion of large-scale, multicenter trials (See Christian MC, et al. New England Journal of Medicine 2002, 346:1405-1408).

Countering these limiting factors, broadening the purview of the CIRB Initiative to enhance the development and delivery of improved therapeutics for pediatric cancer patients will have a synergistic effect on accelerating development and delivery across the spectrum of all cancer types. Such synergies will prove crucial to meeting the challenge goal of eliminating the suffering and death due to cancer by 2015. Implementation of the PedCIRB will occur rapidly, with the first COG protocols planned for review in November 2004.

Phase II and III trials represent the crucial final steps before innovative cancer treatments can take their place as part of the clinical armamentarium. The expanded CIRB Initiative will provide an unprecedented level of support for accelerating these final steps of the discovery-development-delivery continuum. I would like to reiterate NCI's strong commitment to the entire cancer clinical research community to provide the infrastructure and support to facilitate continued improvement and expansion of all clinical trials.

Andrew C. von Eschenbach, M.D.
Director, National Cancer Institute