Recruiting and retaining a patient population with a level of diversity that reflects the general population ranks among trial professionals’ most formidable challenges. Still, if they wish to come up with effective, efficient therapies, attracting a well-rounded set of participants is a must.
Rosamund Round (RR), vice president of Parexel’s Patient Innovation Center, recently spoke with Outsourcing-Pharma (OSP) about the challenges sites and sponsors face regarding trial diversity, why overcoming those obstacles is tantamount, and how to improve recruitment efforts.
OSP: When we say, “diversity in clinical trials,” what exactly do we mean?
RR: Increasing diversity in clinical trials means expanding access for individuals who have traditionally been underrepresented in clinical research while also partnering with them to understand their needs, concerns and barriers to trial participation. This includes African Americans, Hispanics and other racially, ethnically and culturally diverse patient populations as well diverse ages and socioeconomic groups.
For example, US Census population estimates from 2019 show that the African American community represents 13.4% of the U.S. population but, according to the FDA, accounts for only 5% of clinical trial participants. Additionally, the Hispanic community represents 18.1% of the US population and only 1% of clinical trial participants.
In summary, we need clinical trial participants to more closely mirror the populations that new and existing therapies will treat.
OSP: Could you please share some of the reasons it is important to work toward diversity in clinical trials?
RR: An established body of scientific evidence clearly demonstrates that African American, Hispanic, Native American, Pacific Islander and other ethnic populations are disproportionately affected by a variety of health conditions such as cardiovascular disease, type II diabetes, stroke and certain cancers. The lack of diversity among clinical trial participants leads to the approval of medicines and vaccines that have not been tested for safety and efficacy in these high-risk populations and may not effectively treat everyone who has the disease or condition.
Today this is particularly urgent, as COVID-19 has been shown to disproportionally and more severely impact underrepresented groups such as African Americans and Hispanics. Disparities in access to clinical research have continued for many years with minimal improvement, but with new COVID data, the renewed push for social change, and the FDA’s guidance to improve diversity in clinical trials, now is the time for the industry to address this issue in a meaningful way.
OSP: Who benefits from diversity in trials, and how do they benefit?
RR: Improving inclusivity in clinical trials is the only way to ensure that therapies being developed can effectively treat all patients who need them. This includes both culturally diverse populations as well as individuals who are uninsured, underinsured, marginalized or socioeconomically disadvantaged.
Research clearly shows that our health is determined in part by access to social and economic opportunities: income, education, community safety and support, nutrition and other social determinants of health.
To this end, we are working to engage racially, ethnically, culturally and linguistically diverse patients as well as the LGBTQ+ community so that we can truly understand the barriers. Their voices will enable us to put a clear strategy in place to address challenges in partnerships with patient advocates, community leaders, physicians and other key stakeholders. We already work with specialized diversity recruitment organizations and are expanding this service significantly over the coming months.
By improving access to trials, we also greatly expand the pool of available research participants, so not only will patients obtain access to research, but patient recruitment will become easier for sites. This shortens trial timelines, accelerates trial completion and ultimately speeds the development of new drugs to those who need them. Improving diversity is therefore not just a nice idea but an ethical and business imperative.
OSP: Could you please explain some of the reasons why people from diverse racial, ethnic and other underrepresented groups are less likely to participate in clinical research?
RR: Feedback from patients has shown there is an incredibly broad range of reasons for not participating, and which are often unique to respective communities. For some people, it is the challenge of navigating the healthcare system in a new country; for others, it is a lack of trial information provided in their primary language.
Still others have an historical distrust of the healthcare system, or their healthcare providers don’t share the same cultural background and thus patients feel uncomfortable progressing with them through the trial process.
In addition, some cultures attach stigmas to illness and disease, and the extra burden of trial participation could make it more difficult to maintain privacy with family members or their communities. Industry also has a role to play in redressing the balance: Are we selecting trial sites in areas that serve underrepresented communities? Are we effectively leveraging media channels that reach patients from diverse backgrounds? Do patient-facing forms and educational materials utilize language that is inclusive of non-binary patients’ preferred pronouns? There is still a lot of work to be done, but it is wonderful to see such a strong focus in this area to facilitate positive societal change.
OSP: Can you talk about what adjustments might be made in recruitment and outreach efforts, to help bring diversity up?
RR: We use a multi-pronged approach to increase trial diversity and reduce fear and distrust among potential participants, including:
- Working with diverse community leaders to share trial messaging with their respective community members
- Collaborating with patient recruitment vendors that are owned by individuals from diverse backgrounds to draw upon their expertise
- Providing clear and simple educational materials in a variety of languages
- Providing cultural awareness training for site staff
- Engaging patients from a variety of backgrounds via our Patient Advisory Council to learn from their experiences and perspectives on trial participation
In addition, a particularly effective approach to increasing minority participation is sharing testimonials from people of similar demographics who can speak to their experiences and reiterate the value of their participation in advancing the development of new therapies that could help their respective communities reduce chronic disease.
The COVID pandemic is also fostering greater inclusion and diversity by increasing interest in and use of decentralized clinical trials (DCTs). These trials offer greater flexibility in engaging patients who live far from clinical trial sites or who can’t take time off work, arrange for transportation or find childcare.
Decentralized clinical trials help alleviate these barriers by bringing trials to patients instead of asking patients to regularly visit the sites. In turn, this reduces the burden on patients by incorporating trials into their schedules and lifestyles.
At Parexel, we’re working on more than 90 DCTs, including fully virtual (where all visits occur in the home or local community) and hybrid studies (where visits are split between the site and the patient’s home/community). Interestingly, when we began deploying trials in the virtual model, our assumption was that this would have a huge positive impact on our ability to access diverse populations.
We’ve learned this is not always the case. For example, in a recent trial we heard from a site providing treatment to a predominantly Hispanic community that they did not want nurses visiting them in their homes. So, we listened to patients and provided flexibility for them to visit the site or see nurses in a nearby hotel.
By eliciting patient feedback during the development of the study strategy, we can plan for these eventualities and continually learn and improve based on these experiences. All of this means Parexel can design more effective, diverse and patient-centric clinical trials.
OSP: What specifically is Parexel doing to help clinical trial professionals increase diversity?
RR: Parexel has initiated or is contributing expertise to multiple initiatives to enhance diversity in clinical trials, including:
- As part of our collaboration with the Society for Clinical Research Sites (SCRS), we are contributing to the SCRS Diversity Initiative, which is focused on addressing the challenges and opportunities at clinical trial sites while exploring the needs of diverse patient populations in clinical research.
- Through our diversity and inclusion initiatives, we are working to update our trial forms and educational materials to be inclusive of individuals with limited health literacy, language barriers and increased sensitivity to LGBTQ+ patients.
- Parexel has joined the recently initiated Cross Sponsor/CRO Collaborative on Diversity & Inclusion in Clinical Trials, which is focused on promoting greater education and awareness about clinical trials and enhancing trust at the community level.
- Parexel’s Patient Advisory Council is actively working to address the issue of diversity by hosting periodic forums to collect feedback and thus learn from patients of different racial, ethnic, cultural and linguistic backgrounds to understand exactly what we can to improve their trial access and experiences. Feedback to date has been incredibly beneficial for us to understand in detail many of the barriers that we now proactively addressing.
Importantly, these efforts are providing the basis for working with pharmaceutical sponsors early in the patient-centric protocol design process to proactively include strategies to support clinical trial diversity.