Clinical Trials Methods Workshop - Europe

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DESCRIPTION (provided by applicant): Funding is requested to support a workshop entitled: "Clinical Trials Methods Workshop - Europe." The specific aims of this workshop are: (1) To train a group of young clinical investigators in methods in design and conduct of clinical trials; and (2) to evaluate the graduates of the Workshop by determining the percentage who stay in patient-oriented research and meet the other objectives of the Workshop (e.g., complete their protocols, etc.). This Workshop will be offered to young oncologists (from any discipline of oncology) who are just completing their training (approx. 75% of the students) or have recently begun their initial faculty positions (approx. 25% of the students). Training in the design and conduct of cancer clinical trials is, unfortunately, not usually provided in any postdoctoral programs. Training young oncologists in this area should help assure that new therapeutic or prevention agents are tested in the clinic in as sound and as rapid a manner as possible. The proposed Workshop will be organized and conducted by the American Association for Cancer Research (AACR), the Federation of European Cancer Societies (FECS), and the American Society of Clinical Oncology (ASCO). This Workshop is based on a similar, highly successful Workshop which has been conducted in Vail, Colorado, and funded by the National Cancer Institute (NCI) for the past 7 years. The proposed Workshop will be held in Europe because: (a) a second, separate Workshop would enable additional, highly qualified, highly motivated, young clinical investigators from Europe to be trained without diluting the efforts of the Vail Workshop in the United States; (b) students from Europe who would normally apply to the Vail Workshop would not have to travel great distances, thus reducing travel expenses; (c) it facilitates utilization of excellent experienced clinical investigators in Europe as teachers for the Workshop; (d) it allows a cadre of U.S. investigators, who will help teach the Workshop in Europe, gain insight into clinical trial methods and new agents that are being investigated in Europe, potentially enabling those methods and agents to be tested more quickly in the U.S. (e.g., oxaliplatin); (e) it maximizes the return on the investment of the NCI in preclinical work in Europe; and (f) it will produce more clinical investigators with more varied backgrounds to bear on the cancer treatment and the cancer prevention problems. Stringent criteria are in place to select students for the Workshop. 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. There are several innovative teaching techniques utilized in the Workshop, including the requirement that the students complete both a protocol concept sheet and a complete 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. And, finally, a proven evaluation system is in place to demonstrate that the Workshop will meet its objectives.