Robert A. Winn Diversity in Clinical Trials Award Program
Q: What is the goal of the Robert A. Winn Career Development Award?
A: Ultimately the goal is to improve health equity by improving healthcare for underserved and vulnerable people. This program will tackle the challenge by: working within communities, establishing a career development program to train Early Stage Investigators (ESI) URM clinicians, or those with a demonstrated commitment to diversity in clinical trials and building a pipeline of diverse healthcare workers (through an investment in diverse medical students), all of which will help increase the number of underrepresented patients who participate in clinical trials. More participation by people of color in clinical trials will help healthcare providers to better treat the diseases that impact them.
Q: How will this program achieve its aims – and what makes it different than other efforts?
A: The Winn CDA will provide training and resources to build a network of 250 underrepresented ESI minority clinical investigators, or ESI investigators from non URM categories who have demonstrated a commitment to increasing diversity in clinical trials, who will be experts in community engagement as well as clinical research. Also, it will expand the number of community-based sites with the capacity to conduct clinical and translational research, through a clinical trial site development infrastructure fund. Over the longer term, it will increase the diversity of the clinical research pipeline through an investment in 250 URM medical students, equipping them to lead to lead or participate in clinical trial research via an immersive experience in clinical trials and community engagement.
This program is unique because no other program:
Q: What are you going to do to ensure success beyond the just provided training (e.g., what will you measure beyond numbers trained?)
A: 1. For the newly trained/ graduated Clinical Investigators:
2. Increase in enrollment of diverse patient populations in clinical trials (over time compared to baseline)
3. # of RO1 grants for NIH received. Institutional resources connected to scholars (compared to baseline)
4. # of Graduates that built capacity to conduct clinical trials in diverse trial sites.
Q: Why is the Winn CDA focused on the disease areas of Cancer (Hematology and Oncology), Cardiovascular Disease and Immunologic Disorders?
A: These are the therapeutic focus areas of the Bristol Myers Squibb Foundation. The strategy of the Bristol Myers Squibb Foundation is to fund innovative demonstration projects in these areas.
Q: Is the mentor stipend included in the annual $120,000 budget?
A: The mentor’s stipend is not included in the $120k/yr. No, it is not. You do not have to include the mentor's stipend in your budget.
Q: Am I proposing my own research study or am I writing about my mentor's research study?
A: The project that you propose in the application should be the active clinical trial, only the active clinical trial that you'll be working on as part of your career development program under this initiative.
Q: Why is expanding clinical trial diversity so important?
A: Clinical research is necessary to generate evidence for the efficacy and safety of new therapies and some subgroups of patients may respond differently to medical therapies due to genetic make-up. The difference between the characteristics of clinical trial patient participants and those of patients with a specific disease can be seen across the many dimensions of diversity (both demographic and non-demographic characteristics), limiting our understanding of how our treatments might impact different patient groups, and therefore impacting the quality of our data.
Therefore, diversity of clinical trial participants is needed to help ensure that the trial population is representative of the patients who will use the medicine or medicinal product and ensure that the results are generalizable. Further, clinical trial diversity advances equity in provision of health care and accuracy of ethnicity-specific subgroup analyses.
Q: Must I be Underrepresented in Medicine (URM) to participate in this program?
A: While physicians from groups underrepresented in medicine are encouraged to apply, you do not have to fall under the URM population to participate in this program. If you have a demonstrated commitment to increasing diverse patient population in clinical trials, you may submit an LOI.
Q: I have a PhD only. Am I eligible to apply for this program?
A: Unfortunately, as of right now, candidates must hold the degree of MD, MD/PhD, DO or DO/PhD only.
Q: Must I be a US Citizen to participate in this program?
A: Eligible candidates will need to be US Citizens, Lawful Permanent Residents (LPRs) as defined by the US Department of Homeland Security or hold a H-1B or O-1 Visa. The Visa must be valid during the full program period.
Q: I have some experience assisting with clinical trials and completed my medical residency 15-years ago. Do I still qualify for this program?
A: As defined by NIH, a new investigator has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet competed successfully for a substantial, competing NIH research grant. (Applicants with an RO1 or RO1 equivalent are ineligible.)
Q: Am I required to enter funding sources in the LOI, even if I’ve only assisted with my mentor’s research?
A: It is fine if you do not personally have current funding for research and you do not need to include your mentor’s funding.
Q: The handbook mentions a required institutional letter of support from the department chair. At my institution, hematology/oncology is a division, would a letter from the division chair meet this requirement or do I need a letter from the internal medicine department chair?
A: The department chair must sign off on the institutional letter of support. The division chief alone cannot sign off on the letter, as it is a request to use departmental resources and allocation of departmental time.
Q: The handbook mentions a required institutional letter of support from the department chair. At my institution, hematology/oncology is a division, would a letter from the division chair meet this requirement or do I need a letter from the internal medicine department chair?
A: The department chair must sign off on the institutional letter of support. The division chief alone cannot sign off on the letter, as it is a request to use departmental resources and allocation of departmental time.
Q: I plan to work on more than one project during the program period. Can I include a protocol for each project in the application?
A: The Scholar can have multiple projects and must submit a protocol for each project; however, it will be important to describe why and what their roll in each project will be.
Q: In the Winn CDA’s current model, is the mentor expected to dedicate 6-hours per week specifically to the clinical trial proposed in the application?
A: The mentor is expected to dedicate 6-hours per week to clinical trial mentoring on one or more trials.
Q: Am I allowed to have more than one mentor?
A: Yes, each Scholar can have more than one mentor; however, only one mentor will receive the honorarium and only one mentor letter and biosketch should be included with the application.
Q: What will the clinical trials training consist of? Will this be formal coursework (i.e. biostats, epidemiology, writing trials/grants), practical instruction on developing and running investigator-initiated trials and industry-sponsored trials, or a combination of the two?
A: The 2-year Community-Oriented Clinical Trialist (COCT) Training will be delivered in a variety of formats (e.g., didactic lectures, practical workshops, expert panels, and roundtable community discussions) and will provide comprehensive training in clinical research design, funding, and implementation, and in trauma-informed community engagement methods and strategies. An intensive 6-day training in clinical research, designed and hosted by the American Association for Cancer Research (AACR), will precede and set the foundation for the COCT Training.
Q: I am currently a clinician-researcher and dedicate a certain portion of my time to research and a certain portion to clinical care. Do I have to dedicate 40% of my FTE to research only?
A: 40% of the Scholars FTE should be dedicated to research. If there are other research projects that already have a substantial amount of their time taken up, the Scholar may not have time to participate in this program.
Q: How many days or hours per week are required? Will there be specific days of the week or times that need to be dedicated to participation in the program? Can the work be completed after-hours or on the weekends?
A: As this is the first year of this program, we are working to finalize all of the different components. The following are current guidelines, but they are not definitive and will continue to evolve:
Q: Do I need to have an affiliation with a safety net hospital or community health clinic to be considered?
A: The Scholar will need admitting rights to whatever institution that is associated with their mentor’s clinical trial.
Q: My Letter of Recommendation (LOR) writer needs extra time. Is that all right?
A: Yes. LOR writers may have up to two additional weeks to submit their materials. They can also send their letter to us directly at Winnawardinfo@vcu.edu.
Q: When will accepted scholars be notified?
A: Accepted Scholars will be notified in March 2022.
Q: How are accepted Scholars matched with a program city?
A: Factors include applicant preference, local services (i.e., available housing, childcare, etc.), and availability during the program period. Please note the cities are subject to change.
Q: What are my weekly hours for Winn CIPP?
A: Most Site Partners operate on a business schedule (i.e., 9:00 AM – 5:00 PM on weekdays), but this may vary by site. Scholars will follow the schedule established by the placement site.
Q: What is my day-to-day going to be like on site?
A: The daily schedule will vary by site. All Scholars will have exposures to clinical research activities, opportunities for community engagement, learning days, meetings with site leaders, and mentoring by an early-career physician.
Q: May I miss a few days of the program?
A: No. Winn CIPP spans only six-weeks, and Scholars may not miss time on site.
Q: I applied for the NMF PCLP Externship. Am I allowed to participate in both programs at the same time?
A: No. The NMF PCLP and Winn CIPP run concurrently. Applicants can apply for both; however, they cannot participate in both during the same academic year.
Q: Will I have to be vaccinated from COVID-19 to participate in Winn CIPP?
A: Yes, each Scholar will need to provide proof of receiving the COVID-19 vaccination. The Winn CIPP is expanding its COVID-19 vaccine requirement to include a booster shot.
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