1 / 5

Activities for Physicians Visiting CTEP

Join CTEP as a Visiting Physician to engage in daily operations, protocol reviews, meetings, and FDA discussions. Learn about cancer therapy clinical trials and drug development plans under the Investigational Drug Branch.

mcrigger
Download Presentation

Activities for Physicians Visiting CTEP

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related