Clinical trials are critical research studies that evaluate medical, surgical, or behavioral interventions in people. Although clinical trials are essential for determining the safety and effectiveness of new treatments, they’ve historically been inconsistent in representing relevant demographics, such as race and sex, when claiming to be indicative of the broader American population.
Modern clinical research institutions in Virginia are pushing to dispel that narrative by emphasizing the importance of clinical trial diversity in improving clinical data quality, research practices, and, above all else, safe patient treatments.
Read on to learn about Virginia’s growing diversity and inclusion efforts in clinical research, including:
- Why Inclusivity and Diversity Matter in Clinical Trials
- What Causes a Lack of Clinical Trial Diversity
- Underrepresented Groups in Clinical Trials
- Strategies to Enhance Diversity in Clinical Trials
Get in touch with VCCRN’s team to help diversify your clinical trial patient pool.
Why Inclusivity and Diversity Matter in Clinical Trials
The bottom line: Clinical trial diversity and inclusion ensure that a medical treatment suits its intended broader audience. A lack of diverse patients in clinical trials may lead to information gaps and hidden risks, as diseases and treatments may affect populations differently.
The goal of improving diversity in clinical trials is to help researchers rethink how medical professionals approach diseases and manage patients. Clinical trials should be performed on the populations they’re intended to treat.
If a trial claims to serve the broader population but doesn’t accurately test treatment efficacy and safety with a suitable representation of the target public, then:
- The validity of the research data is incomplete and can lead to mistrust.
- The medical treatment may have unintended effects or pose risks to underrepresented demographics.
- Incomplete medical treatment due to underrepresentation in clinical trials may contribute to widening health disparities in marginalized populations and demographics.
- Emerging health policies that rely on incomplete clinical research may also inadvertently widen health disparities for marginalized demographics.
Underrepresented Groups in Clinical Trials
In a 2021 cross-sectional study of 230 US-based clinical trials from 2011 to 2020, analysts found that out of the nearly 220,000 participants, racial minorities were consistently underrepresented while white men were often overrepresented.
Looking at race/ethnicity, the average minority demographics in the studies were:
- 11.6% Hispanic/Latinx
- 10.6% Black/African American
- 5.7% Asian
- 0.4% American Indian/Native American/Indigenous
Compared to the US population:
- 18.9% Hispanic/Latinx
- 13.6% Black/African American
- 6.1% Asian
- 1.3% American Indian/Native American/Indigenous
Accurate population representation in clinical trials is essential given that diseases and medical treatments may impact specific demographics differently. A 2014 review highlighted that nearly one in five new drugs approved between 2007 and 2013 yielded notably different responses across ethnic/racial groups.
Beyond ethnicity, other factors contribute to health risk, treatment efficacy, and likeliness to develop certain diseases:
- Age: The 2021 cross-sectional study found that patients aged 65+ were underrepresented across all trial phases, making up only 12.1% of participants compared to the 16% US population.
- Socioeconomic background: Socioeconomic background is often a precursor to health conditions. It can suggest lower access to quality health resources, health education, nutrition, and more. However, measures such as income alone do not always paint a full picture and may require more insight into life experiences.
- Environment: Living environments can differ greatly by location due to factors such as public resources, exposure to pollution, and even neighborhood segregation.
- Health Habits & Behaviors: Does the patient misuse substances recreationally? Do they exercise regularly or have a sedentary lifestyle? What is their diet?
- Gender & Sexual Orientation: Some diseases or conditions affect the LGBTQA+ community more than other demographics. That could include tobacco usage leading to higher risks for cancers and mental health issues linked with bullying or discrimination.
- Disabilities: Patients with disabilities are often excluded from clinical trials without clear reason.
- Comorbidities: Some patients may have other pre-existing conditions, which should be noted in clinical trials.
What Causes a Lack of Clinical Trial Diversity?
Clinical trials suffer from a lack of diversity for several reasons, both on the clinical research and patient sides:
- Need for Accessibility: Most clinical trials are located in academic or medical centers within large metropolitans, which may be inaccessible to populations on the city outskirts or in rural areas. Clinical trials may also be time intensive, which poses difficulties for patients who work or have other commitments.
- Patient Mistrust: Some demographics have faced historic mistreatment or discrimination in medical settings, such as the lack of informed consent for Black/African American men during the U.S. Public Health Service Syphilis Study at Tuskegee. Clinical research institutions must build public trust in key demographics through transparency and accountability to encourage patient participation.
- Patients Don’t Know About Trials: Patients often don’t know that there are clinical trials available or what their options are without initial medical guidance. Investing in ways to promote clinical trials to relevant patient demographics can increase patient recruitment.
- Language Barriers: Non-native speakers may face difficulties understanding trial requirements and procedures. Working with community healthcare workers (CHWs) or other culturally knowledgeable professionals can expand accessibility to target demographics.
- Lack of Diversity Behind the Scenes: Growing clinical research talent from underrepresented demographics, especially in leadership and patient-facing roles, helps reduce the risk of subconscious biases within the study while broadening the study’s cultural perspective.
Strategies to Enhance Diversity in Clinical Trials & Research
Enhancing diversity in clinical trials requires a multifaceted approach, from dedicated outreach efforts to more accessible clinical research sites. Clinical research institutions and academic journals must also be accountable for enforcing standards for diversity in clinical trials.
Current strategies include:
- The Robert A. Winn Diversity in Clinical Trials Award Program
- Increased accessible clinical trial sites
- Sustainable Community Outreach Campaigns
- Requiring Studies to Include Patient Demographic Data vs Disease Population Data
1. Implementing the Robert A. Winn Diversity in Clinical Trials Award Program
As of 2022, Virginia Commonwealth University (VCU) has led the Robert A. Winn Diversity in Clinical Trials Award Program in partnership with the Bristol Myers Squibb Foundation and other research organizations.
This national program consists of two awards that aim to train and encourage world-class investigator physicians from underrepresented backgrounds or who are committed to increasing diversity in clinical trials to join the clinical research environment. Program participants grow competencies in community outreach, patient engagement, and methods to design clinical trials with diversity in mind.
The result is a growing network of talented investigator physicians who can increase representation behind the scenes and on the patient side.
2. Increasing Clinical Trial Accessibility Through Frontier Sites & Community-Based Trials
A 2018 study from Deloitte discovered that nearly 3 out of 4 clinical trial patients lived more than two hours from the nearest study center. However, patients often live within minutes of health facilities such as clinics, doctor’s offices, medical labs, and pharmacies.
Clinical researchers can leverage these existing healthcare facilities as frontier sites—or healthcare organizations that can easily be equipped to support clinical research studies—to collect routine data during check-ups.
By bringing clinical trial services to local communities through community-based sites, clinical researchers can increase accessibility and encourage more patient enrollment. Reduced travel time can also lower stress for patients with debilitating conditions.
3. Tailoring Patient Recruitment Strategies Through Authentic Community Outreach
In a joint report between Deloitte Center for Health Solutions and Pharmaceutical Research and Manufacturers of America (PhRMA), several core strategies focused on stronger community engagement practices between clinical research organizers and the target populations to enhance clinical trial diversity.
Beyond establishing clinical trial data collection sites in underserved areas, the report emphasized the importance of engaging with community members in the long term to build trust.
Deeper conversations with the target community:
- Help clinical trial leaders stay informed about the community’s priorities, share how they relate to the trials, and support community health education.
- Establish an avenue for transparent and accountable communication regarding patient safety and how their collected data will be used.
- Emphasize the importance of diverse volunteer clinical trial participants in building medical knowledge and improving community health.
- Allow clinical trial staff to tailor their outreach, as well as trial accessibility, based on community needs.
The most sustainable method for community outreach is to collaborate with community leaders to find relevant solutions for clinical trial participation. The goal is to empower people to drive positive change within communities by creating an equitable healthcare ecosystem.
4. Having Scientific & Academic Journals Require Patient Demographic Data vs Disease Population Data
More and more scientific medical journals are drawing attention to the importance of diversity in clinical trials by adjusting their submission requirements. For example, as of 2022, the New England Journal of Medicine requires all manuscripts describing clinical trials to include a table breaking down study participant demographic data vs the disease distribution in the general public. The goal is to stress the importance of diversity and relevant representation in ensuring a medical treatment’s efficacy.
Changes in publishing requisites can encourage diversity in the clinical trial design process early on. Transparency about a study’s patient demographic data can also help instill trust in the trial’s observations while identifying data gaps for follow-up research.
Clinical Trial Diversity Is Crucial for Medical Research
Diversity in clinical trials improves research data quality by ensuring that medical treatments have the intended effect for the populations they serve. By addressing the barriers to participation, including accessible clinical trial sites, diverse clinical research staff, and sustainable community outreach tactics, clinical research leaders can help reduce health disparity in underrepresented demographics through better treatments for all.
Improve your clinical trial diversity through VCCRN’s expansive clinical research network.