Methods in Clinical Cancer Research Workshop

Von Hoff, Daniel

Abstract

Funding is requested for renewal of support for the Methods in Clinical Cancer Research Workshop.
The specific aims of the Workshop are: (1) To train a group of young clinical investigators in methods in design and conduct of clinical trials, including specialized designs for targeted, more individualized therapies;(2) To evaluate the Workshop by determining the percentage of Workshop graduates who stay in patient-oriented and translational research and meet other objectives of the Workshop. This Workshop will be offered to young oncologists (from any discipline of oncology) who are just completing their training or have recently begun their initial faculty positions. Training in the design and conduct of clinical trials is not usually provided in most postdoctoral programs. A review of the literature shows that, at a time of so much innovation in the basic science and preclinical aspects of new agent development, there is a serious shortage of translational/clinical investigators who can actually design and conduct the clinical trials to match the attributes of the new agents. In addition, the knowledge and clinical investigative tools that a clinical investigator needs to be able to understand are increasing at a rapid rate. This Workshop is designed to address that need by training young investigators how to conduct clinical trials in a sound and efficient manner. The proposed Workshop will be organized and conducted jointly by the American Association for Cancer Research and the American Society of Clinical Oncology. This grant was first funded and a Workshop held in July 1996, with competitive renewals granted in 1998 and in 2004. This year, 2008, will be the 13th anniversary of the Workshop, which has now trained 1,269 clinical investigators, the vast majority of whom have stayed active in patient-oriented research. In addition, the students have found that their participation in the Workshop has been invaluable in advancing their career (98% of students). Also, the ongoing mentorship they receive from the teachers of the Workshop has been invaluable to them. Depending upon the year, 50% - 70% of the Vail fellows maintained contact with faculty and/or other fellows after the Workshop for the purpose of faculty mentoring and/or prospects for research collaborations. An outstanding group of experienced clinical investigators and teachers (role models) has been assembled to teach the Workshop in a setting that maximizes contact between students and their teacher mentors. Several innovative teaching techniques are utilized in the Workshop, including the requirement that the students complete both a protocol concept sheet and an entire protocol before the end of the Workshop. This is done under intensive supervision by accomplished clinical trialists and experts in biostatistics, ethics, and other oncologic specialties. Students are also introduced to special imaging techniques and special trial designs for newer targeted therapies and the treatment of individual patients via molecular and clinical profiling. An established and proven short and long-term evaluation system is in place to demonstrate that the Workshop will meet its objectives and continuously strive for improvement.

Public Health Relevance

Von Hoff, Daniel, D., M.D. Workshop on Methods in Clinical Cancer Research Public Health Relevance Statement: This Workshop trains young clinical cancer investigators how to design and conduct cancer clinical trials that produce definitive and positive results. Its goal is to assure that new therapeutic or prevention agents are tested in the clinic in as sound and as efficient a manner as possible. Training - and retaining in the field - clinical cancer trialists will benefit the public health by increasing the speed and number of agents that can be tested and made available to prevent cancer and improve the care and treatment of cancer patients worldwide. PHS 398/2590 (Rev. 09/04, Reissued 4/2006)) Page Continuation Format Page