Diversifying Site Location, Trial Design, & Community Partnerships To Drive Diversity In Clinical Trials

By Noelle Gaskill, MBA, ACRP-CP, head of clinical research collaborations; Shane Jordan, Pharm.D., MS, senior regional health outcomes director; and Rochelle Williams-Belizaire, MPH, CPH, director, clinical research collaborations; Mirati Therapeutics, Inc.

In 2022, the FDA released guidance designed to increase racial and ethnic diversity in clinical trials, understanding that by ensuring diversity and equity in clinical studies, public health advances. The FDA issued guidance in reaction to what is a well-known problem within the drug development industry: People of color make up 39% of the U.S. population but comprise as few as 2%-16% of patients enrolled in clinical trials.¹

Diversity is crucial in clinical research. It allows for more accurate results and a better understanding of how therapies affect different patient populations. By including diverse participants, researchers can better understand the potential effects of a drug on all patients. Excluding underrepresented segments from clinical studies may contribute to health disparities and proliferates unequal access to healthcare.²

The FDA has promoted enrollment practices that are intended to ensure clinical trials better reflect the population primarily through broadening enrollment eligibility criteria.³ However, challenges still exist in ensuring underrepresented groups have access to and enroll in clinical studies.

Creating a diverse and equitable clinical trial requires strategic planning and careful execution. Through a focused approach built on awareness and understanding of the patients in the community and partnership, the industry can better achieve increased diversity in clinical research. This helps to ensure a more equitable approach to drug development and delivery, ultimately advancing public health and well-being.

Reaching Patients In Their Own Community

Nearly 85% of patients living with cancer are treated in community sites.⁴ Community oncology sites are sites equipped to provide care and, often, conduct clinical research. These sites are embedded in the ZIP codes where patients live and are not directly incorporated into a hospital system or academic medical center (AMC). They range from having a few physicians to occupying large, multi-story buildings with nearly 100 physicians and conducting early phase trials (such as Baylor Sammons in Dallas, TX).

Traditionally, industry has heavily relied on AMCs to produce patients for trials; as a result, diversity in clinical trials has suffered.¹ Community sites provide a solution to increasing diversity in clinical research. Partnering with community sites ensures clinical research can reach patients where a majority are receiving their care.

In addition to proximity, community site partnerships provide the opportunity for industry to listen to the leaders of healthcare institutions and understand opportunities to innovate with them. By working with a community site, industry can learn and consider opportunities to encourage greater racial and ethnic minority representation in that particular community, whether that be with a decentralized trial (DCT) or access to just in time (JIT) enrollment. These models reduce the burden on the sites and reach patients where they are receiving their oncology care with a localized, patient-first approach.

Designing Trials To Alleviate Site And Patient Burden

JIT activation of a clinical trial reaches a patient in the specific location where they have been identified and begins in 14 days or less. In a large AMC, such an approach is not needed – patients are generally aware of and guided to trials. But, opening smaller community sites and hoping for a patient to walk in that location’s door is not time- or cost-effective. JIT trials solve the patient access issue and meet them at the door of their local oncologist — and only when they need it.

To be successful, JIT trials must involve internal teams that are experts in this model. This approach has allowed Mirati to successfully deploy JIT across hundreds of community sites, ultimately reducing the burden on the site, as it is only activated when and where (the address or location) they need it. 

DCT models also alleviate the burden on the patient, allowing a trial to reach a patient near or even at their home. This type of model aids in increased diversity in clinical studies by not limiting participation to research sites and to only those patients that have the means to travel there.⁶  Mirati has partnered with Scott Paulson, MD, head of clinical research at Texas Oncology and a Sarah Cannon Research Institute (SCRI) researcher, to develop a centralized research enrollment model, with details forthcoming.

“Over the years in oncology, clinical trial participation has become more public and insistent, from professional societies, patient advocacy groups, and charitable organizations. Enrollment in clinical trials is often difficult, restrictive, and highly concentrated in centers that may not be representative of the true American population, with a focus on the drug and the science, and not whether we are helping people at large,” said Paulson. “Our hope is to try and shift that balance to take a more patient-centered approach, ensuring clinical studies are representative of the general population as it helps us better understand how treatments impact the full spectrum of a diverse group of people.”

Partnering on models that make sense for patients even extends to the U.S. Department of Veterans Affairs (VA). According to the National Center for Veterans Analysis and Statistics, as of September 2021, approximately 28% of the veteran population was noted to be of a racially or ethnically diverse population. ⁵

Michael Kelley, MD, head of lung precision oncology at Durham VA Medical Center, shared that his biggest challenge is reaching the patient who may not have the means to come into the clinic on a regular basis. Reasons for this vary but may include lack of transportation, dependent care costs, distance and time to travel to the clinical study site, or the potential of lost wages.

“We will only improve diversity in clinical research by leveraging the ingenuity that the FDA is stating we should invoke for remote visits, telehealth, and more — essentially the decentralized trial model that we have talked about for years. We are making significant strides with DCTs at the VA, and I challenge other organizations to think of their own initiatives in this space and to make their own progress as well,” said Kelley.

Developing Community Partnerships To Reach Patients

Most recently, Mirati announced a strategic partnership with SCRI focused on increasing diversity in clinical study recruitment practices. As part of this partnership, Mirati and SCRI will implement practices and programs focused on removing obstacles to clinical study participation, including expanding education around testing, learning from patient communities, and increasing access to community-based clinical trials. Across its research network, SCRI has more than 250 community sites in 24 states.

"We will do this through proven and novel approaches designed to reduce barriers to participation that ultimately create a robust pool of clinical study participants that more accurately reflects the real-world patient population. ‘Just in time’ site activation is a particular area that we plan to grow with Mirati across the SCRI footprint,” said Marcy Vallone, vice president, development innovations at SCRI.

Integrating Diversity, Equity, And Inclusion (DEI) Into The Clinical Trial

To be successful at diverse clinical trial recruitment, an entire organization must be aligned on the importance of diversity and representation in trials. It takes listening to the investigators, community sites, and patients, as well as an internal commitment to DEI principles to drive change. As such, it's integral that all employees are educated on the foundations of health equity and the importance of diversity in clinical studies.

Mirati continues to grow our culture of DEI — it is woven into our corporate initiatives and supported through our DEI committee. Over the last several years, our corporate DEI strategy has awarded scholarship, sponsorship, and internship opportunities with community organizations focused on professional and career development for often under-supported and marginalized groups. More tactically and directly impacting diversity in clinical studies, Mirati developed the Clinical Trial Diversity Task Force to deploy and measure tactics for the inclusion of a diverse patient population. The task force directly supports clinical trial teams on JIT and DCT while providing insights from partnership projects in the community, DEI efforts, and more — all designed to meet the ask of the FDA and of the community partners to reach and include diverse patients.

Diverse thought and experience from community stakeholders allow for the discovery, development, and delivery of innovative medicines that may help patients living with cancer. Our Clinical Trial Community Forum, slated for later this year, will amplify the voices of those living with cancer and those of their care providers as they offer insights into best practices and solutions to address health disparities in clinical research. By promoting education and fostering open dialogue, we can drive positive change and contribute to advancing health equity and diversity in clinical trial research.

References:

1. Harvard Business Review. Addressing Demographic Disparities in Clinical Trials. (Accessed June 2023).
2. National Institute on Minority Health and Health Disparities. Diversity and Inclusion in Clinical Trials. (Accessed April 2023).
3. U.S. Food & Drug Administration. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. (Accessed April 2023).
4. AACR Cancer Disparities Progress Report 2022. AACR_CDPR_2022.pdf. (Accessed May 2023).
5. National Center for Veterans Analysis and Statistics, 2022
6. Forbes. Compelling Economics of Decentralized Trials. (Accessed May 2023).

About The Authors:

Noelle Gaskill, MBA, ACRP-CP, head of clinical research collaborations, Mirati Therapeutics, Inc., is a research executive with over 25 years of experience spanning across the industry from sites to biotechnology. In her tenure of leading large-scale research organizations, she successfully deployed novel just in time recruitment models, patient identification initiatives, and even developed study start-up technology – all with the purpose of reducing the burden on the site. Today, she leads clinical research collaborations on behalf of Mirati Therapeutics using her knowledge of community oncology and site operations to build unique collaborations that ensure successful accruals – a perfect fit for her personal motivator of providing novel oncology therapeutics to all patients close to home.

Shane Jordan, Pharm.D., MS, senior regional health outcomes director, Mirati Therapeutics, Inc., is a board-certified pharmacotherapy specialist with experience spanning both solid tumors and hematology. He is responsible for providing clinical and pharmacoeconomic data to national and regional healthcare decision makers in the southeast. Shane also has a courtesy faculty appointment with the University of Florida College of Pharmacy. Shane received his Doctor of Pharmacy from Florida A&M University College of Pharmacy and School of Public Health, followed by his Master of Science in applied pharmacoeconomics from the University of Florida. Shane is a champion for health equity and serves his local community through active engagement by offering medicine “brown bag” seminars and local health topics of interest.

Rochelle Williams-Belizaire, MPH, CPH, director, clinical research collaborations at Mirati Therapeutics, Inc., is a clinical research professional with over two decades of experience in the biomedical research industry, mostly in the academic setting. In each of her roles, Rochelle has successfully driven projects that address social determinants of health, as well as cultural and communication gaps to address health equity in cancer care. In her current role, Rochelle leverages her experience in leading sites to establish and grow unique partnerships in clinical research. She has served on a number of nonprofit boards and executive councils focused on health equity.