The Clinical Trials Working Group (CTWG), a panel of 40 clinical trialists, advocates, and government representatives established in 2004 by NCI Director Dr. Andrew C. von Eschenbach to evaluate the national cancer clinical research enterprise, will report draft recommendations to the National Cancer Advisory Board (NCAB) this week.

As part of its transparent, inclusive approach to increasing cancer clinical trials efficiency, decreasing redundancy and administrative burdens, and better coordinating activities to enhance the development and delivery of the best therapies to people with cancer, CTWG welcomes public comment on the draft recommendations. Final CTWG recommendations, to be presented to NCAB in June, will incorporate public input.

Last year, CTWG formed subcommittees to address six key issues: coordination across different funding mechanisms, regulatory issues, core research services, patient accrual, standardization and infrastructure, and prioritization. So that the community at large could convey suggestions about the future of cancer clinical trials, CTWG posted 27 questions pertaining to these areas on its Web site. Thousands of clinical trial stakeholders, including academic clinical investigators; community medical oncologists; patient advocates; and representatives from government agencies, industry, and professional groups, were invited to provide input and submitted over 2,200 replies.

These replies informed the activities of the CTWG subcommittees who were simultaneously formulating draft recommendations. Among the recommendations refined by public input is a proposal for NCI to establish a correlative science budget to be accessed on a protocol-by-protocol basis. Web responses noted the lack of funding for correlative studies as a barrier to robust clinical trials. Web responses also overwhelmingly agreed that standardizing many elements of clinical trials would improve the quality of studies. Similarly, a draft CTWG recommendation is that NCI establish standards, in concurrence with the Food and Drug Administration (FDA), for appropriate data collection. Another important initiative identified by both public responders and CTWG is a Web-based informational tool on all federally funded cancer clinical trials.

Although I chair CTWG, the group's recommendations represent the consensus of the extramural research community - a diverse group of researchers making up the majority of CTWG members - along with NCI staff. Thus, the subcommittee chairs, representing various clinical trial stakeholder groups, will present the draft recommendations on February 17, at 8:30 a.m. Eastern Time (available at http://videocast.nih.gov).

The subcommittee chairs and co-chairs are Drs. David Johnson, president, American Society of Clinical Oncology; David Alberts, director, University of Arizona Cancer Center; Richard Schilsky, chair, Cancer and Leukemia Group B national cooperative group; Fred Appelbaum, director, Clinical Research Division, Fred Hutchinson Cancer Research Center; David Parkinson, vice president, Amgen; Peter Adamson, chief, Clinical Pharmacology, Children's Hospital of Philadelphia; James Abbruzzese, director of the NCI-sponsored pancreatic SPORE at the University of Texas M.D. Anderson Cancer Center; Mark Ratain, Cancer Research Center, University of Chicago; Richard Pazdur, director, FDA Division of Oncology Drug Products; and Steven Averbuch, executive director, Merck Research Laboratories.

In addition to comments from NCAB, CTWG will continue to seek community input on the recommendations. Instructions on how to comment on the draft proposal will be posted on the CTWG Web site (http://integratedtrials.nci.nih.gov) following the NCAB presentation. I know CTWG members look forward to continued interactions in defining a new cancer clinical trials infrastructure that will lead us to accelerating the translation of novel cancer therapies into the clinical oncology community.

Dr. James H. Doroshow
Director, NCI Division of Cancer Treatment and Diagnosis