The purpose of Winn CDA funding is to protect 40% of Scholars’ work time for program participation, which includes research activity, training, career development planning, program events, and reporting. The following are mandatory Winn CDA requirements:
Clinical Research Activity
Each Scholar shall be mentored by an experienced clinical investigator at an established clinical trial site and participate substantively in the mentor's active clinical trial. (It is not expected that the scholar will have their own clinical trial.) Research projects must meet the FDA Clinical Trial Definition - research studies involving human volunteers to evaluate medical products like medications, vaccines, or devices for safety and effectiveness.
Day 1 Virtual Orientation (Mid-October)
The Winn CDA Virtual Orientation welcomes and introduces all stakeholders to the program. The 3-hour webinar is usually held on a Friday afternoon in mid-October.
BMSF-AACR Design and Implementation of Clinical Trials (DICT) Workshop (November 14-19, 2022 - Santa Monica, CA)
BMSF has partnered with the American Association for Cancer Research (AACR) to develop and deliver this 6-day intensive training that increases the reliability, reproducibility, and effectiveness of clinical trials by introducing physicians to the principles of good clinical trial design. The DICT Workshop is typically conducted in-person in early to mid-November.
Community-Oriented Clinical Trialist (COCT) Training (2 Years, Virtual, Mid-November through October)
The two-year Community-Oriented Clinical Trialist (COCT) curriculum features comprehensive training in clinical research design, funding, and implementation and in trauma-informed community engagement methods and strategies. Scholars will develop and initiate clinical protocols and present them at Winn CDA Annual Convenings.
The COCT curriculum has three main components:
1) Bi-Weekly Scholars Forum: Scholars meet virtually with COCT faculty for seminars, professional skills workshops, and roundtable discussions with guest speakers. The Forum begins in mid- to late-November and is held bi-weekly, typically on Fridays at 12:00pm-3:00 pm ET.
2) Community Engagement: Scholars will be given assignments to practice trauma-informed community engagement and partnership building skills and to deepen their knowledge of their catchment areas, e.g., by hosting focus groups, key informant interviews, and listening sessions.
3) Capstone Project: Each scholar will design and develop a mentored research protocol proposed during the program period. The capstone will focus on major issues in research protocol development, including development of a research question, methodological issues regarding different research designs, and plans for analysis. Scholars will submit draft clinical trial protocols by the midpoint of Year 2 of the program and will present their protocols at the Year 2 Winn CDA Annual Convening.
Individual Professional Development Plan
Each scholar will develop an Individual Professional Development Plan (IPDP) informed by a skills assessment that will guide the training activities scholars pursue during the program. The IPDP will address both clinical research skills (e.g., statistical analysis, biostatistics, etc.) and career/professional development skills (e.g., public speaking, technical report writing, project management, networking, etc.). It will serve both as the training and career development roadmap and the individual scholar monitoring and outcomes tracking record.
Winn Clinical Investigator Pipeline Program (CIPP) Student Mentoring (June 13 - July 22, 2022)
During the summer, Winn CDA scholars serve as mentors to URM medical students who are considering clinical research as a career pathway. The students are participants of the 6-week Clinical Investigator Pipeline Program (Winn CIPP), where they learn the basics of community-engaged clinical research. The Winn CIPP runs mid-June to late July.
Winn CDA Annual Convening (November 14-15, 2022 - Santa Monica, CA)
This annual two-day event, held at the end of each program year in late October or early November, brings together key program stakeholders to inspire, amplify, educate, and celebrate. The agenda includes sessions addressing diversity in clinical research and skills development and features scholar presentations. Scholars will have the opportunity to network with each other and a range of program stakeholders (e.g., National Advisory Committee, leaders in clinical trial research, and local National Medical Fellowships alumni).
Scholars must submit the following expenditure and progress reports:
1) Bi-annual Winn CDA Status Reports, due March 31 and September 30 of each program year.
2) Annual Winn CDA Funding Reports, due October 31 (Year 1) and November 30. (Year 2)