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139th National Cancer Advisory Board

Dr. Doroshow next described efforts to improve the infrastructure for investigators. To help investigators, a RAID principal investigator training program will be developed and implemented, and a policy and procedures manual will be created. Currently, a RAID Investigator 101 course is under development, incorporating FDA and NCI collaboration. Regulatory support services also will be made available to RAID principal investigators to assist in IND submission and avoid delays in trial initiation, facilitate subsequent interactions with the FDA, and improve planning for clinical trials. Because of the expense involved in Phase I trials, NCI Clinical Center resources are being made available to individuals who have RAID projects to open trials. Currently, three trials open at the Clinical Center include materials that were made by the RAID program to assist investigators either in speeding the accrual process or providing a different schedule for the application of a particular agent. This service will be reevaluated as new data become available and guidance will be posted on NCI’s Web Site.

Program metrics will be developed by RAID program staff and widely communicated. Initially, the metrics focused on the number of completed projects and how many INDs were filed. There is now a shift toward clinical endpoints, such as the completion of early phase clinical trials and the number of patients treated. The development of prospective criteria by which to evaluate and discontinue projects has been discussed. In addition, RAID staff will review regular milestones for each project. Project discontinuation will be guided by a lack of productivity, a change in scientific rationale, and a change in portfolio focus.

Questions and Answers

Dr. Von Hoff noted that only 35 out of 81 INDs filed were approved and asked about the INDs that were not approved. He commented that Phase I trials are not enough to engage other players into working with a specific agent or IND, but rather hints of activity, such as a decrease in circulating tumor cells or functional imaging, are needed. Dr. Tomaszewski responded that in some instances, the projects failed to progress along the necessary milestones to reach the clinic; moreover, many agents were approved only for early activities and not for progression into clinical trials. Mr. Ingram observed that research and development chiefs of private companies are willing to engage in dialogue with the NCI and Cancer Centers to help improve outcomes, noting that everyone suffers in the zero-risk environment. Dr. Niederhuber supported Mr. Ingram’s offer to serve as head of an NCAB subcommittee advisory group to work with the RAID program on drug development. Dr. Chabner reflected that a strategy is needed to take agents through Phase I and into Phase II, and it should work in tandem with Cancer Therapy Evaluation Program (CTEP) and the DDG. Dr. Doroshow responded that the RAID program was established to take compounds into Phase I, whereas other NCI mechanisms work with Phase II studies. Ms. Giusti stated that a number of organizations—such as the Juvenile Diabetes Research Foundation International, the Cystic Fibrosis Foundation, and the Michael J. Fox Foundation—have been successful in working grants through various levels of trials and may serve as models. Dr. Coffey raised the possibility of establishing a comprehensive cancer board, similar in scope to a War Board, to examine major societal issues related to cancer. Dr. Barker stated that there appears to be a cultural difference between what is accomplished by the RAID program and what occurs in the R01 investigator laboratories.

XV.

PROGRESS REPORT: NCI INNOVATIVE MOLECULAR ANALYSIS TECHNOLOGY (IMAT) PROGRAM—DRS. ANNA BARKER, GREGORY DOWNING, STEPHEN J. KRON, AND JAN E. SCHNITZER

Introduction—Dr. Anna Barker

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