Central Review Board Will Speed Implementation of Pediatric Clinical Trials
The PedCIRB is an expansion of the NCI Central IRB (CIRB) Initiative, begun in 2001, for simplifying the review of Institute-sponsored Cooperative Group treatment studies. The CIRB provides an innovative approach to human subject protection for adults through a "facilitated review" process, which aims to streamline local IRB reviews of national multicenter cancer treatment trials.
"The PedCIRB will ease the administrative burden on institutions that participate in clinical studies involving children and adolescents," said Dr. Barry Anderson of NCI's Cancer Therapy Evaluation Program (CTEP). The PedCIRB will act as the clearing IRB for pilot, phase 2, and phase 3 clinical trials conducted by the Children's Oncology Group (COG). COG currently enrolls approximately 4,000 children and adolescents in treatment studies annually and has 70-80 studies open to patient accrual each year. "Local IRBs at the 238 institutions that comprise COG will decide individually about affiliating with the PedCIRB. Those institutions that join can decide on a case-by-case basis whether to approve the study using the PedCIRB review or to conduct their own assessment of the protocol," said Dr. Vita J. Land, executive director of the PedCIRB.
Every cancer study and its patient consent form must be approved by an IRB that includes physicians, ethicists, patient advocates, and others who help to ensure that any trial that cancer patients enter is ethical, informs them of potential risks, and maintains their confidentiality. A local IRB's consideration of a study can take weeks and involves a large investment of professional and volunteer time. Since most studies sponsored by NCI are conducted at multiple institutions, the same protocol is reviewed by each of the multiple local IRBs.
Jacquelyn Goldberg, who directs the overall initiative for NCI, commented, "The PedCIRB, similar to the adult Board, should reduce the necessity for duplicate reviews." Local IRBs must still ensure, through an abbreviated approval procedure, that the investigators and other staff at the local institution are appropriately qualified. Local IRBs will still monitor protocol compliance. The composition of the central IRBs is similar to that required for local IRBs, except that it has the unique advantage of being able to draw on pediatric oncology expertise from across the whole country.
The 17-person PedCIRB includes 10 physicians with pediatric subspecialty expertise, 2 nurses, 1 bioethicist, 4 patient advocates, 1 pharmacist, and 1 statistician. This diverse membership will ensure that the PedCIRB provides broad clinical and ethical expertise for the review of COG treatment protocols. In view of the special considerations required for the evaluation of research involving children, the board members' extensive experience reviewing pediatric clinical trials is a valuable asset to the PedCIRB.
Easing the difficulties local IRBs face in meeting administrative and regulatory demands should facilitate swifter and more efficient trial start-up and completion. Enhancing the development and delivery of improved therapeutics for pediatric cancer patients will prove crucial to meeting the challenge goal of eliminating the suffering and death due to cancer by 2015. The PedCIRB plans to review its first COG protocols in November.