Project Summary/Abstract The Methods in Clinical Cancer Research Workshop is a week-long program designed to educate and train early-career investigators in the best practices of clinical trial design, provide access to experienced clinical investigators from different institutions with expertise across all areas of clinical research, and develop and foster both peer-to-peer and mentoring relationships to enhance career development beyond the dates of the Workshop. Students are selected using a competitive application process that consists of a protocol concept, personal statement, and support from an existing mentor. Those accepted to the Workshop will have access to dozens of faculty members who, through the course of the Workshop, will help students develop concept sheets into IRB-ready clinical trials, including informed consent documents, ready for submission at their home institutions. Students participate in pre- and post-tests to determine the effectiveness of the program, which features a mix of didactic lectures, small group discussions, one-on-one mentoring sessions, and daily protocol development group sessions. The protocol development group sessions are made up of 3-4 faculty members and 8-10 students that work collaboratively as a group for the week. This makes up the core of the Workshop as the groups meet daily to review progress made each day and provide feedback and guidance for next steps in their individual trial designs. Daily, progressive assignments are submitted each evening, with reviews and comments from the faculty provided the following morning. The Workshop is offered to early-career investigators in all oncology disciplines who are nearing completion of their training or have recently begun their initial faculty positions. A review of the literature, comments from Workshop attendees, and the number of similar programs being developed in the U.S. and internationally shows that, despite advances in basic science and new preclinical agent development, there is a serious shortage of clinical investigators who have the pre-requisite knowledge to actually design and conduct effective clinical trials to match the attributes of these new agents. With the ever-increasing pace of technology and its implications in clinical trial design, the knowledge and number of tools that a clinical investigator needs to be able to utilize effectively continue to grow at a rapid rate. The Workshop is designed to address the needs today, while maintaining flexibility to implement changes to train early-career investigators on how to conduct effective clinical trials in the future. The Workshop is organized by the American Association for Cancer Research and the American Society of Clinical Oncology and has provided training to over 1800 investigators since its’ inception in 1996. The Workshop is evaluated through the use of pre- and post-tests given to the students; daily and week-long evaluations completed onsite; a 1-year, 3-year, 5-year, and 10-year followup survey each fall. The Workshop also contracted with an independent data-mining and analysis firm in 2013-2014 to provide a long-term historical comparison of students and non-students (applicants that were not accepted) that quantified their effectiveness pre- and post-Workshop in the areas of successful clinical trials, publications, grants, and collaborations.

Project Narrative The Workshop trains early-career investigators how to design and conduct cancer clinical trials that produce definitive results. Its primary goal is to assure that new therapeutic and preventive agents are tested in the clinic in as sound and as efficient a manner as possible. Training, mentoring, and retaining clinical cancer trialists benefits 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.