DMMC Course CANCER BIOLOGY TO CANCER MEDICINE

1300-1400 Friday 26 May 2006.
Durkan Lecture Theatre, Institute of Molecular Medicine, TCD, St James's Hospital

State of the Art Lecture III: Clinical trial designs for early drug development
Dr Jennifer Low (National Cancer Institute, Washington, USA)

As more targeted therapies enter clinical testing, it has become apparent that while the traditional models for testing chemotherapeutic agents are not ideal for targeted therapy, a suitable replacement model is not yet evident. New methods to choose the agents most likely to succeed are necessary before agents enter the clinic, and surrogates with shorter endpoints to determine agent efficacy need to be developed in conjunction with the agents that require them. This lecture will include a discussion about trial designs for early drug development and the impact of the new FDA guidance for Exploratory Investigational New Drug (IND) applications.

Resources

Reference: Seymour, L. (2002). The Design of Clinical Trials for New Molecularly Targeted Compounds: Progress and New Initiatives. Current Pharmaceutical Design 8, 2279–2284. PubMed Entry

Reference: Ma, B.B., Britten, C.D., Siu, L.L. (2002). Clinical trial designs for targeted agents. Hematol. Oncol. Clin. N. Am. 16, 1287–1305. PubMed Entry