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Overcoming Pharma's Diversity Problem
Decentralized clinical trials and a more patient-centric approach can make trials more appealing to all demographics
Mark Brown, Vice-President, Global Patient and Site Services, IQVIA
Mar 15, 2021

Mark Brown, Vice President, Global Patient and Site Solutions

In 2001, the U.S. National Institute of Health (NIH) mandated that women and members of minority groups must be included in all NIH-funded clinical research, unless developers could make a compelling rationale otherwise. It was a foundational moment in clinical research, requiring the biopharmaceutical industry to acknowledge that diverse studies deliver safer and more effective new drugs.

20 years later, sponsors are still struggling to recruit diverse populations in a truly representative way based on therapeutic incidence levels. Among new molecular entities and biologics approved in 2020, just 11 percent of participants were Hispanic, eight percent were Black, and only six percent were Asian.

Sponsors have discovered that it is not easy to assemble a perfectly diverse patient population that also meets all inclusion/exclusion criteria. Facing the simultaneous pressure to lower costs and accelerate timelines, diversity goals can often slide down the priority list.

However, the growing adoption of decentralized clinical trials (DCTs) may now help make recruiting diverse, representative groups of participants more achievable – without adding significant time and cost to the trial.

Miles to go

Studies show that excessive travel is one of the most significant barriers to trial participation – and that underserved minority communities often face the biggest burden. One 2018 report found that while trial participants traveled an average of 25.8 miles to get to a trial site, patients from lower-income areas traveled more than twice that distance – 58.3 miles vs. 17.8 miles for affluent participants.

The time and cost associated with that level of travel quickly becomes untenable, causing patients from these communities to decline enrollment, or to drop-out when the commitment becomes too great. This results in sites limiting their recruiting efforts to patients who live within the local community, which can skew the population to a homogenous demographic.

DCTs eliminate much of this travel burden, by cutting some or all on-site visits from the trial experience. If patients only need to travel to a site a handful of times, the occasional multi-hour trip can feel more reasonable. And if the trial is completely virtual, any patient with internet access can participate from anywhere in a targeted geography – no travel required. This opens recruiting to far-flung communities, and to those who don’t have a car or access to public transportation.

It also means sites can rethink their recruiting paradigm to focus more on outreach in diverse communities, using new channels to attract new patients to a trial such as digital patient communities.

However, dealing with travel burden is only the first step. While DCTs dramatically reduce logistical barriers, sponsors and recruiters must address patients’ fears about trial participation, and do more to bolster awareness about trials as a source of care.

Unconscious bias: The hidden barrier

The National Academy of Sciences found that people identifying as black, indigenous, and people of color (BIPOC) are still less likely to receive appropriate medical services, and that they experience a lower quality of health care than whites. This disparity is often the result of unconscious bias among healthcare providers, who tend to display more positive attitudes toward white patients.

These disparities have been reinforced throughout history, but they have been in the spotlight during the pandemic as data shows people of color experience consistently higher rates of hospitalization and death from COVID-19 than those in white communities.

These are disturbing trends that have caused many BIPOC to be skeptical of clinical trial participation. But drug developers can overcome these concerns through authentic outreach, education, and transparency about what the trial will involve, and how patients and the community will benefit.

These solutions will require some rethinking of the recruiting and trial process. Initial steps can include:

  • Ensuring the investigator teams and trial recruiting staff are diverse and representative of the communities they serve.
  • Hosting focus groups with targeted patient demographics to discuss their trust concerns and listen to their past experiences with bias. These focus groups can be a learning opportunity for sponsors and recruiters and give minority communities a chance to be heard and become the catalyst to implement positive changes.
  • Working with physicians and healthcare facilities in communities of color to engage patients and educate them about the benefits of clinical trials as a care option. As with any population, patients are more inclined to consider trial participation if the suggestion comes from a professional who they trust.
  • Offering flexible options for participation, including telehealth meetings, e-diaries and connected devices that reduce the amount of time and travel required to participate in a trial.

Worth the effort

When sponsors include representative patients in their trials – to truly reach those who are impacted by a disease - it can result in more effective treatments. That is beneficial for sponsors, sites and patients.

DCTs give sponsors the technology to overcome the physical barriers that limit diversity in clinical trials. When DCTs are combined with more diverse recruiting strategies and personnel, research will be well-positioned to achieve better outcomes.

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