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

• 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

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

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

Typical week

Monday Tuesday Wednesday Thursday Friday

*OEWG TC Company meetingsOEWG TC

IDB-LOIs

Concept Review

ProtocolReviewConsensus

PD meetingsOEWG TC

Company meetings

Translation. Research Program(Intramural)

CTEPProgram Meetings

CTEP-FDAMonthlyMeeting

*Operational Efficiency Working Group teleconferences