should improve site activation of clinical trials and monitoring of patient recruitment to trial protocols.

Operational efficiency of trials. NCI is reviewing strategies for improving the speed with which trials are initiated and conducted and is focusing on two key areas:

  • Bottlenecks in trial development—A recent study (Dilts et al., 2009) found that for NCI-sponsored phase III clinical trials, the time from concept submission to trial activation by a cooperative group required a median of 602 days. The study also revealed that at least 296 distinct processes are required for activating a phase III trial, including 238 working steps, 52 major decision points, 20 processing loops, and 11 stopping points. NCI hopes to streamline this process and has set a goal of reducing the time from concept approval to trial activation by 50 percent. Possible areas of improvement in the process include Institutional Review Board (IRB) approval and industry contracting.

  • Interaction with the U.S. Food and Drug Administration (FDA)—If an NCI-sponsored phase III trial involves a treatment with a potential licensing indication, a company may express interest in the trial and become a barrier to its activation. Thus, it is crucial to obtain FDA review of and comments on a potential licensing indication at an early stage. To eliminate this source of delay in conducting trials, NCI has developed a process for obtaining FDA input on a phase III trial at the concept stage so that a company’s licensing of a potential indication can be completed as early as possible.

Enterprise wide restructuring and oversight. NCI-wide advisory committees and coordinating groups have been created to oversee the entire clinical trials enterprise and progress on the four initiatives described above. Mooney is hopeful that the next several years will yield improvements in efficiency across the NCI cooperative group system.

  • adjudication committees’ fees—more of an issue outside of the United States (adjudication committees are necessary when endpoints of time-to-event are used, such as progression-free survival in cancer); and

  • fees associated with IRBs and Data Monitoring Committees (DMCs).

At each phase of clinical research (phases I, II, and III), the cost increases. Canetta explained that the later the stage of development in which a compound fails, the higher the cost of that failure will be. In cancer, the



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