MAJOR ONGOING INITIATIVES

Improving the Clinical Trials System

In addition to implementing recommendations of the Clinical Trials Working Group (http://integratedtrials.nci.nih.gov/), CTEP is making other changes to accelerate the development of new interventions.

CTEP has established the following priorities:

• Accelerating therapeutics development by:

  • Speeding the concept approval process by meeting with cooperative group phase III investigators, as well as partners within the Food and Drug Administration (FDA) and industry, to resolve clinical trial issues in a rapidly scheduled joint meeting and discussion process rather than in a time-consuming iterative review process

  • Decreasing the time from concept approval to protocol implementation by developing joint Protocol Development Teams with the cooperative groups

• Increasing the transparency and expertise of the CTEP review process by engaging external scientists and advocates in the review of all concepts for phase III trials

• Expanding access to clinical trials through continued growth of the Cancer Trials Support Unit (www.ctsu.org)

• Continuing improvement of the informatics infrastructure that supports clinical trials by continuing development of clinical trials standards, including the common toxicity criteria and common data elements, and by the development and implementation of a remote data capture system for the collection of clinical trial data