CLINICAL TRIALS - The Mission to Increase Diverse Clinical Trial Participation

Clinical trials are critical to advancing medical knowledge and new therapeutics. It is important that participants in clinical trials represent their entire communities and the potential recipi­ents of new treatments. If participants are not diverse, clinical tri­als may not be able to accurately evaluate how well new treatments will work in underrepresented groups. In a study of more than 20,000 trials representing approximately 4.7 million participants, researchers found that only 43% of the trials re­ported data on race or ethnicity.¹ Without accurate reporting of race and ethnicity data, there is no way to ensure clinical research centers are achieving trial enrollment that represents their com­munities.

Headlands Research is a leading international network of clinical trial sites. The company was established with the aim to significantly increase clinical trial participation, provide faster study start-up, improve patient retention, and exceed industry standards with high-quality data. Its network of exceptional sites across the United States and Canada gives the company a sub­stantial footprint in the clinical research landscape and allows it to profoundly impact the trials process by focusing on diversity, quality, and cutting-edge technology.

“Headlands Research’s goal is to enable the approval of high-quality therapeutics that will benefit all patients in need, with a particular focus on the inclusion of populations that are tradi­tionally underserved in terms of ethnicity and geography,” said Mark Blumling, CEO and Founder of Headlands Research.

Headlands Research aims to tackle systemic barriers that communities of color face when trying to access clinical trials by combining its network’s experience in building sustainable, local clinical trial infrastructure with efforts that address lack of out­reach, patient mistrust, and lack of available sites. Headlands’ work has already begun with a new, groundbreaking partnership with a leading pharmaceutical company that will further advance Headlands Research’s mission to improve diversity in clinical tri­als.² This partnership will launch new research sites in areas with highly diverse, medically underserved populations.

New research finds that more than half of clinical trials do not report race and ethnicity data. SDI Productions/Getty Images. “Only 43% of clinical trials report race and ethnicity — What can be done?,” by Timothy Huzar, 21 April 2022. Medical News Today.

“Diversity is a key pillar of Headlands Research’s commit­ment to ensure clinical trials represent broader populations,” said Mark Blumling. “We are proud to partner with a leading phar­maceutical company as we take another meaningful step forward toward achieving this extremely important goal.”

The importance of diversity in clinical trials cannot be under­stated. For reference, a Phase 2 trial of an Alzheimer’s disease drug included 360 participants in 83 sites and six countries. Even with its large geographic footprint, the study featured 97.5% White patients and only 2.8% Hispanic patients. Hispanics are one-and-a-half times more likely to be diagnosed with Alzheimer’s than White people.³ The participants in this trial were not reflective of the population this drug would aim to treat. This problem is reported in multiple other studies. Black men and women make up 15% of cancer patients but are only 4%-6% of cancer trial participants.⁴

There are several examples of previous research studies, such as the Tuskegee Syphilis Study conducted in the early to mid-twentieth century, which did not protect the rights and welfare of participants and caused unnecessary harm and deception among minorities. Despite the creation of regulatory bodies, such as In­stitutional Review Boards, minorities are more likely to be skepti­cal of scientific research than non-Hispanic Whites.¹ That is why rebuilding trust in communities is a critical focus of Headlands Research.

The partnership’s first site is located at Headlands Research’s facility in Brownsville, the largest city in the Rio Grande Valley, which spans the southernmost tip of Texas. The Brownsville site focuses on multi-therapeutic and general medicine studies and has exten­sive experience in COVID-19 trials. Headlands Research’s alliance with its pharmaceutical company partner is a multi-year commitment to create mul­tiple diversity-focused sites. The Brownsville site has already implemented health fairs that include free health screenings, lunches, and educational talks from leading health experts. They have also sponsored the annual health and wellness fair hosted by the Brownsville Chamber of Commerce, where they connected with members of the community and provided them with information on upcoming vaccine trials and their no-cost health screen­ing services.

In the past, prioritizing diverse clinical trial enrollment and retention has been met with minimal success. Headlands Research intends to change the landscape of the clinical trial process and offer a much-needed plan to eliminate health disparities and inequities in underrepresented groups. With more than 5,000 completed studies, 25 plus therapeutic areas of expertise, and more than 210 years of site research since its establishment, Headlands Research has the experience and the tools necessary to be a leader on the mission to increase diverse clinical trial participation.

REFERENCES

1. Only 43% of clinical trials report race and ethnicity — What can be done? Medical News Today, April 2021, https://www.med­icalnewstoday.com/articles/only-43-of-clinical-trials-report-race-and-ethnicity-what-can-be-done.
2. Pfizer teams up with Headlands Research to launch trial sites in more diverse areas Fierce Biotech, May 2022, https://www.fierce­biotech.com/cro/big-pharma-pfizer-paves-road-clinical-trial-diversity-new-partner-headlands-research.
3. ‘We just don’t have the studies’: New report details critical diversity shortcomings in US clinical research Fierce Biotech, May 2022, https://www.fiercebiotech.com/biotech/we-just-dont-have-studies-new-report-details-critical-diversity-shortcomings-us-clinical.
4. ASCO: Black breast cancer patients want to participate in trials, but adequate information is hard to come by Fierce Biotech, June 2022, https://www.fiercebiotech.com/cro/black-breast-cancer-patients-want-participate-trials-adequate-information-hard-come-survey.

Lauren Chazal is the Chief Business Development Officer for Headlands Research. She began her career in clinical trial operations with a privately held multi-site clinical research organization. Since 2012, she has held a pivotal role in business development and relationship management for clinical research sites globally. She graduated from Lehigh University with a dual degree in Finance and Marketing and from the University of Florida with an MBA.

Keidra Gaston is the Director of Marketing for Headlands Research. She began her career in business development for a hospital system and has held a lead role in marketing for a top healthcare insurance organization. She earned her MBA from Prairie View A&M University and her BA in Communication-Journalism from the University of Houston.