NCI to Restructure Clinical Trials System

June 13, 2005—The National Cancer Institute (NCI) announced a sweeping restructuring of its clinical trials system on June 7, 2005, after a thorough review by the Clinical Trials Working Group (CTWG). The recommendations put forth by CTWG will help NCI to capitalize on advances in molecular medicine that offer enormous potential to improve cancer clinical practice as well as deal with the new challenges facing the design and conduct of cancer clinical trials. Implementing the recommendations will address four themes: coordination, prioritization/scientific quality, standardization, and operational efficiency and cost approximately $113 million over five years. The CTWG’s full report is available online.

“These recommendations propose integrating the best of all components of NCI's clinical trials system into a cross-disciplinary, coordinated research endeavor for moving therapies to patients,” said James H. Doroshow, MD—Director of NCI’s Division of Cancer Treatment and Diagnosis—who spearheaded CTWG. “This new, cooperative enterprise will be supported by a strengthened scientific infrastructure and a broadly engaged coalition of critical stakeholders.”

In 2004, NCI Director Andrew von Eschenbach, MD, convened CTWG to advise the Institute on optimizing the NCI-supported clinical trials system. CTWG presented 22 recommendations for restructuring the NCI’s clinical trials enterprise that were accepted by the National Cancer Advisory Board (NCAB). By accepting the CTWG report, NCAB endorsed CTWG’s recommendations to NCI.

Under the plan’s coordination initiative, NCI will create a comprehensive database containing information on all NCI-funded trials to facilitate better planning and management across all clinical trial venues. Prioritization/scientific quality initiatives include the creation of an investigational drug steering committee to refine the design and prioritization of early-phase drug development trials. Moreover, NCI will improve patient accrual rates and better address quality of life concerns in trials by increasing the involvement of community hematologists/oncologists and patient advocates in their design.

The plan outlines several initiatives under the standardization category, including the creation of national cancer clinical trials information technology infrastructure that works in concert with NCI’s cancer Bioinformatics grid. The report states that this closer association will improve cost effectiveness and allow for the comparability of results across trials and sites. For operational efficiency, NCI plans to restructure phase III funding models to promote rapid patient accrual as well as cost effectiveness, reduce institutional barriers to timely trial initiation, and increase public awareness and understanding of clinical trials.

Dr. von Eschenbach commended the CTWG report asserting, “This report and its implementation plan represent a critical step to reaching the NCI goal of ending the suffering and death due to cancer by 2015. The recommendations lead to creating a clinical research infrastructure that will unravel the molecular mysteries of human cancer and rapidly implement interventions that will preempt the cancer process.”

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