Message from the CTEP Associate Director

CTEP is responsible, within DCTD, for coordinating the largest, publicly funded oncology clinical trials organization in the world. With over 900 active trials enrolling annually 30,000 study participants, nearly 400 grants and cooperative agreements, and about 100 investigational new drugs (INDs), CTEP's staff of almost sixty talented physicians, scientists, pharmacists, nurses and regulatory specialists, assisted by multiple government contractors, works diligently to assure the safe, efficient and ethical conduct of this complex research enterprise. CTEP-sponsored research spans phase 1-3 trials in all cancers and treatment modalities - chemotherapy, immunotherapy, radiation and surgery.

Despite rapid changes in oncology on multiple fronts, I am pleased that CTEP continues to fulfill a vital niche in cancer clinical research. Our attractiveness to our academic and pharmaceutical collaborators over the years stems from our focus on the development of cancer treatments, not only cancer drugs. For example, CTEP has been able to effectively team with different companies to develop multiple targeted therapies in phase 1-2 trials. These combinations hold the promise for both more effective and less toxic treatments for many cancers. Thanks to CTEP's Cooperative Group program, active treatments found in phase 2 studies can be moved rapidly into definitive phase 3 trials. The Cooperative Groups, with nationwide and international research sites, both in academic and community practices, provide a standing, time-proven infrastructure that is capable of testing multi-modality therapies, and can provide tissue and other specimens that enable the tailoring of therapy to specific tumor types. Group trials are now available to physicians and their patients more broadly than ever before via the Cancer Trials Support Unit (CTSU), a CTEP-sponsored one-stop shop for all regulatory submissions and trial enrollments for all Cooperative Group trials.

During the ongoing implementation of many Clinical Trials Working Group (CTWG) initiatives, CTEP has played a major role. For example, the Investigational Drug Steering Committee and Disease-specific Steering Committees have been successfully integrated into CTEP's overall mission to produce treatments that cure cancer or prolong the length and quality of life of those afflicted. CTEP will continue to embrace changes in our programs that are geared to helping us achieve our mission.