A conversation with Monique Gary, DO, MSc, FACS, FSSO, breast surgical oncologist and medical director of the Grand View Health cancer program
It’s all about perspective, they say, when you’re facing a challenge. And for “Dr. Mo,” as she’s called by friends and followers alike, it’s about three distinct perspectives when it comes to assessing and improving upon diverse patient enrollment in breast and lung cancer clinical trials.
With experience as a medical director, an IRB board member and PI, and an academician, Dr. Mo sees all sides the systemic issues of reaching and recruiting Black, brown, LGBTQ+, and other underserved populations for participation in clinical research.
In this Q&A, she discusses the current climate for diverse patient enrollment as well as ways in which sponsors, sites, advocates, and others can use their influence for the better.
As A Medical Director
Clinical Leader: At a recent American Society of Clinical Oncology conference, you were part of a presentation that shared the results of an interactive video program assessing clinician perceptions and practices of, as well as patient awareness and interest in, clinical trials. The goal was to address racial/ethnic disparities in breast and lung cancer clinical trials. What are those racial and ethnic disparities?
Dr. Mo: During a recent ASCO presentation, we specifically looked at the disparity in incidence and mortality. We perceived low participation of patients from racial and ethnic minorities when looking at their clinical trial enrollment rate compared to their proportion in the U.S. population. Notably, Black patients have the lowest clinical trial enrollment rate across all racial/ethnic groups in breast cancer incidence.
Tell us then about the creation of these interactive video programs. And what were the thoughts behind them to help address barriers to clinical trial enrollment?
Participation in clinical trials, whether yielding positive or negative results, garnered overwhelmingly positive feedback, shining a light on the genuine desire within underserved and underrepresented communities to be engaged in clinical trials. Programs like this help to explain what clinical trials are – like slicing into a cake to see what’s inside. This in turn helps to dispel long-standing myths deeply ingrained in our culture while instilling a hope that clinical trials benefit participants. We hope this will create a positive and lasting impact on diversifying future enrollment rates.
Of the patient respondents, survey results showed that, after the program, the majority were motivated to research clinical trials (38%) or discuss clinical trials with a clinician (19%). And notably, after the program, 79% were confident to very confident discussing clinical trials with a clinician — a boost of 23%. The results indicated increased confidence in talking about clinical trials, but not the same level of interest in pursuing participation in one. What do you make of that difference? And what is to be learned from that?
Every experienced clinician understands that clinical trial enrollment is far from a simple binary choice of "yes" or "no." It involves a multifaceted process that deserves substantial support. Institutions lacking such crucial support, such as dedicated clinical trial nurses and research coordinators, have historically struggled to achieve high trial participation rates. While educating clinicians on the need for clinical trials and equipping them with the language for meaningful trial conversations with patients, it's crucial to recognize that patients may face significant barriers. They may lack the resources or access to actively enroll in trials, and in many cases, the trials they require may not be available within their institutions.
We also discussed the concept of decentralizing trials and structural impediments in clinical trial recruitment. We believe that fostering collaborations between pharmaceutical companies, organizations, and industry partners with community institutions will shed light on these barriers, revealing opportunities to establish partnerships that not only enhance awareness and conversations but also result in increased trial enrollment.
As An IRB Board Member And PI
In your experience with clinical trial recruitment, what are some of the marketing efforts for patient recruitment that simply don’t work (or work well) anymore? What’s new in those efforts that seem to be gaining traction and bringing in more patient participants?
Providing patients with brochures alongside their initial diagnosis materials is not an effective strategy. Patients typically receive numerous pamphlets about support organizations and nonprofits during their diagnosis, making it unrealistic for them to inquire about a trial after reading those pamphlets.
Trials discussion should become a standard part of the patient's care journey. By introducing this concept early and normalizing it, rather than presenting it as something experimental or a last resort, patients can better engage with the idea and feel more empowered to ask questions or revisit the topic after they have digested the materials. Having a trial coordinator available to answer questions and engage in these discussions with patients can be an invaluable tool for gauging patient interest and providing additional education.
Yet, providing bilingual and inclusive trial brochures is particularly beneficial for hearing-impaired individuals. Technology, such as QR codes, trial portals, and websites, has emerged to help patients identify suitable trials based on their specific diseases and stages. These strategies offer patients the support and information they need to make informed decisions about clinical trial participation.
Of course, there’s no one size fits all for patient recruitment, retention, or enrollment in clinical trials. In thinking about diverse patient populations — especially those in Black, brown, and LGBTQ+ communities — what cultural idiosyncrasies must be recognized and respected in order to gain that population’s awareness, trust, and, ultimately, participation?
It's important to acknowledge that trust isn't a given; it must be earned, especially among populations with a history of medical malfeasance, leading to the existing medical mistrust. Clinicians need to go the extra mile to meet these patients where they are and build a trusting relationship before offering a clinical trial. Actively offering open conversations for patients to share their stories and health concerns, while listening to their challenges in medical care access are effective approaches to initiating a bond and establishing trust with these communities. This process may take time and require education, patience, and cultural humility as historical trials have often disadvantaged these patients.
Additionally, it's crucial to recognize that patients must have their basic needs met before they can even consider participating in a clinical trial; many of them are still grappling with challenges such as getting to their appointments and affording copays. To be inclusive, we must proactively address these barriers and establish a culture of respect by actively listening to and understanding a patient's perspective and values. These are essential steps to expanding the pool of clinical trial participants.
What, too, is the importance of having a site staff and/or PI that is culturally representative of target patient populations? And what impact does cultural competency training have in fostering understanding for those CRPs that aren’t of a minority group but desire to understand and empathize with them?
Representation holds great significance for historically underrepresented and underserved communities on the fringes of medical advancements and scientific progress. When we examine the participation rates of Black, brown, and LGBTQ patients, we observe historically low numbers. To foster a culture of trust and belonging, our health systems should undergo transformative experiences that parallel the experiences we want our patients to have.
This transformation involves inclusivity at all levels of healthcare, encompassing staff, nurses, physicians, researchers, clinical personnel, and patient-facing administrative staff. Such inclusivity enhances patient comfort, ensuring they feel valued and recognized, ultimately cultivating an undercurrent of trust.
Cultural competency training is indispensable, given that fewer than 2% of healthcare professionals are Black. While it may not be feasible for every institution to have a diverse representation, it is achievable to help those working in these communities make patients feel comfortable and seen. This training is particularly vital because representation remains limited.
Research indicates that training, safe zones, and inclusivity initiatives matter not only to patients but also to our colleagues and the overall health of our healthcare systems. By aligning these efforts, we can effectively enhance trial representation.
As An Educator
As an associate professor at Dartmouth University, you piloted a program called “Patients as Visiting Professors.” Tell us more about the initiative and its outcomes.
The "Patients as Visiting Professors" program had a dual purpose: empowering patients to advocate for themselves and educating clinicians from the patient's perspective. It sought to enable patients to share their journey and learnings from their diseases as actionable programs that can educate researchers with qualitative data from their lived experiences. It can also be very empowering and healing for patients to share their stories beyond the hospital or doctor's office, and it’s a way to establish a community or connect with others on similar paths. This data-driven approach, rich in didactic content, underscored the value of the patient experience.
The outcomes were exceptional, as students engaged enthusiastically, gaining motivation to participate in research with advocacy groups. These organizations are becoming increasingly sophisticated and actively driving patient involvement in clinical trials.
Given your role as an educator, what perspective do have, or what do you see about the clinical trial industry, that might not be as apparent to others?
In the evolving partnership between the clinical trial industry and advocacy groups, there's a critical missing link: the clinician. As an educator, I see the importance of clinicians offering trials to patients, as even the most well-designed trials can remain unfilled without this crucial connection.
What I observe is a growing collaborative effort, with more seats added at the table, bringing patients, pharmaceutical companies, and clinicians together more than ever before. This collaborative approach holds great promise, and I see tangible success on the horizon. I believe that in the coming years, the data will demonstrate the fruitfulness of our efforts in enhancing trial representation.
About The Expert:
Monique Gary – “Dr. Mo” – is a breast surgeon, educator, entrepreneur, media personality, farmer, and philanthropist. Gary currently serves as the medical director of the Grand View Health/Penn Cancer Network cancer program, where she also serves as director of the breast program.
Gary completed her medical degree at the Philadelphia College of Osteopathic Medicine, and her general surgery training at UMass, followed by the Breast Surgical Oncology Fellowship at Georgetown University Hospital. She holds faculty appointments in surgery and serves as the Associate Professor for Race & Health Equity at Dartmouth Geisel School of Medicine and as a medical advisor/contributor for national breast cancer advocacy organizations.
Gary is also building a movement to achieve true health equity and help communities develop holistic and integrative approaches to cancer care and wellness. She is CEO of Still Rise Farm, a 40-acre farm that was founded as a “wellness incubator” for cancer patients and under-resourced, marginalized communities. She can also be found on radioOne stations in Philadelphia giving tips for healthy living and cancer risk reduction, and weekly on Blackdoctor.org as the co-host of “The Doctor Is In.”