NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
September 26, 2006 • Volume 3 / Number 37 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Director's Update

Guest Update by Dr. James Doroshow

Workshop Helps RAID Program Adapt, Evolve

Dr. James DoroshowLaunched in 1998, NCI's Rapid Access to Intervention Development (RAID) program has become an important resource for investigators engaged in anticancer therapeutics development. In July 2005, a workshop was held to comprehensively review the RAID program, and determine ways to improve its effectiveness and overall operation.

The report from that workshop - which was chaired by Dr. John Mendelsohn of the University of Texas M.D. Anderson Cancer Center, and involved experts in cancer research and drug development from the country's top academic centers and industry - includes important recommendations that should greatly strengthen NCI's drug development capabilities.

As Dr. Niederhuber explained earlier this year in the NCI Cancer Bulletin, RAID provides a bridge between discovery and the introduction of an agent into phase 0 or phase I human clinical trials by offering invaluable support - including bulk drug production, formulation, pharmacokinetics, and toxicity testing, among others - to principal investigators (PIs) working on the development of small-molecule drugs and biologics.

While drug company scientists have such services at their disposal, many academic researchers do not, so RAID offers access to crucial drug development resources to the research community. In addition, RAID fills an important niche because it supports PIs who are working on rare diseases and pediatric malignancies, and attempting to validate new therapeutic targets.

Overall, the recommendations from this new report call for NCI to actively monitor individual project milestones and achievement of timelines, and to intercede with changes or “go/no-go” decisions. This will ensure that RAID resources are being used in the most efficient manner possible.

NCI will immediately begin to implement a recommendation for the establishment of a two-tiered review system to optimize the prioritization and use of RAID resources. This will entail the creation of a standing committee of extramural experts to oversee the overall operation and function of the RAID program - the RAID Oversight Committee - and two subcommittees, one for biologics and one for small molecules, to aid in the review of specific applications, feasibility, and project management plans.

In response to another recommendation, NCI will also establish teams to advance RAID-approved projects. Project managers with expertise in both science and managing therapeutic development teams will work with PIs and NCI staff to formulate and implement comprehensive development plans for the RAID agents, including timelines, milestones, and resource requirements.

Other changes that will be made in response to this report include:

  • Mentoring and training for RAID PIs, including training programs on the development and submission of Investigational New Drug (IND) applications to the FDA and an annual workshop
  • When needed, regulatory assistance in the filing of INDs
  • If feasible and when necessary, conducting initial clinical trials at the NIH Clinical Center to ensure that agents in which a substantial investment has been made will be tested in first-in-human trials; assistance with conducting trials at a PI's institution may also be available

A number of other changes to the RAID program also will be implemented over the coming year. Our goal is to ensure that we are getting the maximum return on our investment.

As some of the exciting results from early-stage trials involving RAID-supported agents suggest, this program has the potential to make a substantial difference in the lives of many patients. We believe the reviewers' recommendations will make the RAID program stronger and lead to many new effective cancer treatments.