The NCI Pediatric Central Institutional Review Board (PedCIRB) Initiative: Progress and Impact
20/06/2007
Conference Paper
Authors:
Anderson, B.D.;
Goldberg, J.;
Adler, J.;
Covington, L.;
Olson, D.;
Gordon, B.;
Reaman, G.;
Everett, J.;
Smith, M.;
Christian, M.
Secondary:
2007 ASCO Annual Meeting
Volume:
25
Publisher: J Clin Oncol
Abstract:
NCI has developed a central IRB (PedCIRB) to review NCI-sponsored pediatric clinical trials conducted by the Children's Oncology Group (COG). COG comprises 200 U.S. medical institutions and protocol activation traditionally requires separate protocol review by each local IRB (LIRB) and, subsequently, a review of each protocol amendment and significant adverse event. The PedCIRB model seeks to increase patient protection by improving the expertise of protocol reviewers and making their review available to all PedCIRB participating institutions. The PedCIRB consists of experts in pediatric oncology, pediatric medicine, nursing, pharmacy, bioethics, biostatistics, as well as patient advocates and childhood cancer survivors. The PedCIRB model also eliminates redundant reviews, reduces administrative burdens on local COG investigators and LIRBs, and can accelerate the pace of local protocol activation, thus increasing the availability of clinical trials to children with cancer. The PedCIRB conducts a full board protocol review that is available via a confidential website to participating LIRBs. LIRBs can choose to perform a facilitated review, using PedCIRB materials, that focuses on local concerns, rather than a full LIRB protocol review. If the LIRB accepts the PedCIRB review, the PedCIRB becomes the IRB of record for that protocol and takes responsibility for the review of subsequent protocol amendments, adverse events and continuing reviews. Since starting in November 2004, the PedCIRB has reviewed 59 protocols. Initial reviews resulted in 44 approvals pending modification and 15 protocols being tabled for further information. The time from protocol submission to final approval by the PedCIRB has ranged from 3 to 28 weeks with an average time of 16.9 weeks during year one and 12.7 weeks during year two of the project. As of November 2006, 117 of a possible 197 U.S. COG institutions (59%) have signed on to the PedCIRB initiative and 70% of the participating institutions have conducted facilitated reviews (total 750) for the 30 protocols available on the PedCIRB website. The PedCIRB's influence on protocol development and patient accrual timelines will be discussed.
