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Activities for Physicians Visiting CTEP

CTEP Visiting Physician Externship Coordinator: Igor Espinoza-Delgado, M.D. NCI CTEP Investigational Drug Branch espinozaIg@mail.nih.gov. Activities for Physicians Visiting CTEP. Visiting physicians (VPs) are involved in the day to day operations of CTEP

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Activities for Physicians Visiting CTEP

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  1. CTEP Visiting Physician ExternshipCoordinator: Igor Espinoza-Delgado, M.D.NCI CTEP Investigational Drug BranchespinozaIg@mail.nih.gov

  2. Activities for Physicians Visiting CTEP • Visiting physicians (VPs) are involved in the day to day operations of CTEP • In close collaboration with Sr. Clinical Investigators, VPs will be asked to: • Sign a confidentiality agreement • Provide review of incoming protocols and LOIs • Be present for internal meetings and for discussion between CTEP and pharmaceutical companies in evaluation of new agents • Participate in discussions between CTEP and FDA regarding the development of new agents • Observe concept reviews in which prioritization of cooperative group phase III clinical trials are taken

  3. Investigational Drug Branch Responsible for: • Implementation and monitoring of a comprehensive cancer therapy clinical program that sponsors clinical trials of novel agents that have demonstrated high activity in relevant pre-clinical models. • Creation of drug development plans (Phase I, II, and III trials) for anti-cancer drugs and coordination of both intramural and extramural investigators and the pharmaceutical industry in the design and the conduction of these trials. • Reports concerning adverse events (AEs) for all INDs. • Annual reports to FDA on oncologic drugs

  4. Current CTEP Workload • Average # of documents received per month over the last 5 months: • Concepts - 6 • LOIs – 16 • Protocols – 21 • Revisions – 55 • Amendments - 193 • As of May 2010, there are approximately 1145 ongoing CTEP sponsored studies

  5. Typical week *Operational Efficiency Working Group teleconferences

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