Diversity and Inclusion in Clinical Trials

Do you want to know more about diversity in clinical trials? 

Are you a Sponsor looking to develop a robust clinical trial strategy?

Would you like to develop foundational skills as a clinical research scientist?

If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well.

Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices. 

She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations. 

It’s because of Jenn’s direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance. 

Most recently, Jenn has been involved in Abbott’s efforts in designing studies that include a diverse group of underserved clinical trial participants. 

As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research. 

My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more.

I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.

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Show Notes

[4:05] Jenn’s background as a Ph.D. student in exercise physiology, what is a biomarker, Jenn’s family background in the field of medicine

[6:22]   Jenn’s first clinical research job after college studying blood pressure drug therapies

[7:18] Transition from academic to industry i.e. Abbott Laboratories 

[8:30] The role Jenn’s childhood played in her career, the difficulty her grandfather faced to pursue medical degrees as an African American, and Jenn’s father’s experience in internal medicine as a physician assistant

[10:54] Medicine is global then why can’t it be that those who are providing care are doing the research to ensure that there is care through therapies, look like all of us who get treated.

[12:54] Jenn’s current role as a scientific program director at Abbott Vascular where her team is responsible for a portfolio of cardiology medical devices that treat the blood vessels and getting them approved, designing and conducting clinical trials, presenting the data, writing up the data, and interpreting the data

[14:09] How do we make our clinical trials more equitable? 

[15:38] Factors that impact diversity and inclusion in clinical trials

  • Identify clinical sites that are in areas where many of these patients may be underserved
  • including physicians and research sites that actually look like the patients that that that are serving those communities

[16:34] There is a lack of understanding among patients about what is a clinical trial. We need to educate patients about clinical trials (clinical care opportunity).

[19:09] Dealing with patient’s lack of trust

[21:41] Site selection and physician education as it relates to enrolling diverse patients in a clinical trial 

[23:49] Developing a clinical trial strategy 

  • Understanding the disease state and unmet need
  • What is the standard of care and what is contemporary care?
  • What is the business objective? Consider budget, timelines, resources, regulatory expectations
  • Identifying physicians that are going to work with you, their current day to day practice, and how it’s going to change as a result of the trial and/or medical product 

[27:40] How do we know we have the right physicians to help us out with our clinical strategy?

[29:23] 29:23 Making medical device clinical trial decisions keeping in mind the patient and how not to get lost when writing the protocol 

[32:53] Understanding patients of certain disease states and what is their general hospital expectations of having to come back to see their physician

[35:43] What are some of the lesser known but important considerations when it comes to protocol compliance?

  • Understanding the burden on the site
  • Inclusion and exclusion criteria too rigorous

[38:47] Navigating relationships with your Key Opinion Leader (KOL)

[40:24] Foundational skills for a clinical research scientist 

  • Understanding research methods, questions, hypotheses, and data interpretation
  • Creative curious problem solver
  • Wanting to learn
  • Be an independent thinker
  • Be able to work in the team
  • Caring 

[42:54] Developing skills through experience and time, and paring new team members with individuals with experience and knowledge

[45:04] Acquiring new knowledge through reading journal articles and exchanging information (discussing) with an expert and/or peers

[49:01 Advice for people who feel that the cards are stacked against them. Ask the following questions:

  • What do I want?
  • What do I need to get there?
  • Where is the gap?
  • What’s missing?
  • Who can help me get there?

Resources Mentioned

University of Texas Southwestern Medical Center

University of Maryland

Abbott Laboratories 

University of California, San Francisco

Food and Drug Administration

Starbucks frounder Howard Schultz

Medpage Today

TCT MD

[Book] Seven and a Half Lessons About the Brain by Lisa Feldman Barrett

Lisa Feldman Barrett’s TED Talk 

Your Brain is Not For Thinking 

Peace Is Every Step: The Path of Mindfulness in Everyday Life by Thich Nhat Hanh

Mindful of Race: Transforming Racism from the Inside Out by Ruth King

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