Clinical Trials Have Struggled with Diversity Issues for Decades. It’s Time to Fix That

By Greg Kefer at Lifelink Systems

COVID-19 has placed clinical research in the spotlight. Americans have been anxiously following vaccine development and deployment, the only light at the end of a very long tunnel. While the Moderna, Pfizer, and Johnson & Johnson trials recruited participants at unprecedented rates, the pandemic has revealed and exacerbated a problem that has existed for decades: clinical trials struggle to recruit diverse participants that reflect real-world patient populations.

For example, black patients represented just 10% of the participants for both Pfizer and Moderna vaccine trials, despite making up over 13% of the US population. This has unique consequences, as black patients are disproportionately affected by the virus. They are more likely to experience severe cases of COVID-19, with increased likelihoods of hospitalization and death. Therapies do not work exactly the same way in every patient population and failing to recruit diverse trial participants can have unexpected downstream consequences on how investigators understand therapy response by age, gender, race, and disease state.

While the pandemic has certainly brought this issue to light, the majority of clinical trials have always lacked diversity. The FDA’s drug trial snapshots reveal that 76% of the almost 293,000 patients who participated in trials between 2015 and 2019 were white. Only 7% were black, and only 13% were Hispanic. Minority patients are also severely underrepresented in clinical trials for specific therapeutic areas: black patients make up only 2.5% of participants in cardiovascular disease trials, despite carrying a disproportionate burden of heart disease.

And it’s not just race — clinical trials also suffer from age and gender diversity issues. For example, 15% of COVID-19 vaccine trials systematically excluded adults between the ages of 65 and 80, even though 80% of COVID-19 deaths occur in patients above 65. Two-thirds of cardiovascular disease trial patients are also male. 

Diversity in clinical trials is not about good PR. It has important consequences for drug efficacy for different patient groups, with 20% of drugs demonstrating differences in response across racial and ethnic groups. A highly-cited genetic study from 2018 revealed that albuterol and other inhaler drugs do not work as well for black and Puerto Rican children as it does for white or Mexican children. It’s imperative that clinical trials recruit the diverse patient populations they need to uncover these insights earlier in the pre-approval process, instead of finding out years after therapies are approved.

What Causes Lack of Clinical Trial Diversity?

There are four key barriers to minority participation in trials: 1) mistrust and lack of comfort with the process, 2) lack of information, 3) time and resource constraints, and 4) lack of awareness. 

Mistrust and Lack of Comfort

Hesitation from minority groups to participate in trials stems from inherent distrust of the healthcare system. This distrust is grounded in historical racism, stemming from unethical experimentation on minority patients. Take the infamous 1932 Tuskegee syphilis study, for example, where penicillin was withheld from black men so researchers could track the progression of the disease. Research has also exposed racial bias in pain assessment and treatment, with half of medical students believing that there are biological differences between black and white patients. It’s not surprising, then, that 55% of black Americans say they distrust the healthcare system.

Lack of Information

There is also a lack of comfort and information surrounding the clinical trial process. For many, the process of enrollment and participation is daunting. Clinical trial educational materials don’t help matters, either. Most healthcare materials are written at a 10th grade reading level, but 1 in 3 Americans are in “basic” or “below basic” health literacy groups. 

Time and Resource Constraints

Next, minority patients are also more likely to experience time and resource constraints that make it difficult to participate in trials. Patients in households making less than $50,000 a year are 27% less likely to participate in trials. When a patient is juggling multiple jobs or lacks access to transportation and childcare, getting to the clinical trial site can be difficult.

Awareness

Finally, minority patients simply aren’t made aware of clinical trials to begin with. Only 25% of black patients and 27% of Hispanic patients say their doctors have talked to them about enrolling in clinical trials. Physicians often think that minority patients are not good fits for trials and believe they are more likely to be non-adherent. As a result, they are less likely to recommend clinical trials to their minority patients compared to their white patients.

The FDA Can’t Solve This On Their Own

With the number of clinical trials skyrocketing 150x since 2000, the need for regulatory intervention on this diversity issue has never been more important. While some strides have been made in setting expectations and increasing transparency surrounding diversity, these efforts have been too little, too slow.

The NIH first required women and minorities to be part of clinical trial representative samples in 1993. The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) called upon the FDA to present an action plan to Congress to improve demographics of clinical trials. Since then, the FDA has released Drug Trial Snapshots with summarized demographic breakdowns of clinical trials, in an attempt to increase transparency. It has also released guidance for clinical trials on how to develop eligibility criteria so the participants match the patients likely to receive the drug.

While these efforts certainly help shed light on the issue, they don’t provide clinical trials with a toolkit for how to overcome the barriers to clinical trial participation listed above. Clinical trial coordinators need concrete solutions, not just recommendations.

How Conversational AI Solutions Can Level the Playing Field

Addressing Mistrust and Lack of Comfort

While mistrust in the healthcare system can’t be solved overnight, digital patient engagement solutions that are intuitive, informative, and conversational can help rebuild trust and reduce the friction involved in the trial process. Conversational technology (digital assistants) can provide a non-judgemental, accessible space for patients to get their questions answered at their own pace before approaching a care team that may feel intimidating. Helping patients understand what they’re signing up for, next steps, and progress through the trial protocol can provide a level of comfort and visibility that is often missing from the trial experience.

Today’s patients are demanding better digital communication tools to improve their healthcare experience. 60% of patients want to manage their healthcare digitally based on their experience with virtual care management during COVID-19. Over half of them would be more comfortable getting care from providers that offer better virtual tools to understand and manage their care. 

Improving Education and Comprehension 

Today’s trial experience often requires patients to review lengthy, dense content to enroll and participate. While many trials make these materials available via websites and PDFs, conversational technology has matured, making it possible to deliver trial materials to patients in natural, intuitive conversations. Instead of relying on scattered CRAs across trial sites to educate patients, digital assistants make it possible to meet every patient at every site, in their own language, when they need help. Real time answers 24/7, built-in comprehension checks, and seamless escalation to CRA teams can go a long way towards improving patient understanding for historically underserved populations.

Reducing Time and Resource Constraints

The shift to remote clinical trials can help address some of the time and resource constraints that would have prevented underrepresented patients from participating in traditional site-based research. A mobile-first smartphone strategy is key. Instead of forcing patients to travel to the site for each visit, trials should leverage smartphone based engagement to allow them to complete screening and enrollment and report PROs from the comfort of their own home. 

With 81% of Americans owning a smartphone and becoming increasingly reliant on digital channels, meeting patients in their preferred channels is the best way to reduce barriers to trial participation and retention.

Boosting Awareness

A mobile-first strategy is also the best way to improve more diverse top of funnel awareness of trials. 26% of Americans earning less than $30,000 a year are “smartphone only” Internet users, the highest of any income bracket. Optimizing trial recruitment strategies to meet these patients with smartphone-friendly trial education and pre-screening can help augment traditional site- or paper mail-based recruitment channels to reach a wider range of potential participants.

Healthcare isn’t immune to the diversity issues currently plaguing our country. It’s time to build and invest in real solutions to help ensure that clinical trials are recruiting not just enough patients, but the right patients.