One of the main issues the life sciences industry is grappling with is the lack of diversity in clinical trial populations, particularly in terms of race and gender. Diversity in clinical trials is fundamental in ensuring people have equal access to novel and potentially life-saving medicines, regardless of their backgrounds. By deploying technology in a thoughtful, empathetic manner, we can ensure that patients for whom participating in clinical trials may seem inaccessible, such as those from minority or lower-income backgrounds, are afforded the same opportunities as others.
Diversity: not a ‘nice to have’, but an imperative
The lack of diversity in clinical trial populations has a negative impact on the reliability and generalizability of trial data. Measuring the safety or efficacy of a treatment based on a study conducted in a non-diverse population does not provide a representative picture and means that important insights that may be gained from a more diverse trial population are ignored. For example, genetic differences may impact the likelihood of certain genders or racial backgrounds experiencing adverse events relating to certain drugs. In addition, some diseases disproportionately affect specific groups, meaning any clinical trials in these indications should mirror this population.
Targeted trial recruitment using AI
When in-person visits to a trial site are required, AI tools can be used to find trial locations that can help encourage specific demographic cohorts to enroll, allowing researchers to better connect with communities from which they want to recruit patients. This does not mean imposing quotas, but simply making sure that the trial population reflects the real-world population affected by a particular condition. As well as improving the diversity of the study population, using AI in this manner can also save time and money, as enrollment challenges, including recruitment and retention, are one of the major reasons that trials struggle to get up and running or complete on time.
In addition, enrolment statistics can be monitored using AI once a trial has started enrolling patients, providing real-time insights on the diversity of the patient population. This means study teams can adjust their recruitment processes as needed to target specific populations. This could be through building relationships with community leaders or organizations to increase trust and raise awareness of the importance of participating in clinical research, or by targeting different geographic areas.
Bringing the trial to the patient using technology
One of the most significant barriers preventing patients from participating in trials is the associated financial and logistical challenge. In-person clinical trials are typically conducted in large hospitals in major metropolitan areas. For individuals on lower incomes, or those who live far away from trial sites, factors such as access to and cost of transport, sourcing childcare or securing time off work can make participating in clinical trials a significant burden and often puts off prospective patients.
Technology can play a significant role in relieving this burden by enabling remote participation in clinical trials. Decentralized trials leverage tools such as telehealth appointments and remote data collection through electronic diaries and wearable devices to bring the trial to the patients and allow them to participate from the comfort of their homes. This dramatically improves the patient experience, relieving the time, logistical and financial pressures associated with having to visit a trial site and mitigating factors that may have led them to not participate.
We must be mindful, however, that some individuals can be cautious when using technology, particularly in a clinical research context. In communities where there is a level of mistrust in the healthcare system due to historical exclusion or exploitation, or systematic exclusion, this can raise concerns around data privacy. In addition, those from lower socioeconomic backgrounds may not have high levels of digital literacy or own their own devices.
It is therefore important to ensure that patient-facing technology is as simple and user-friendly as possible, and that we continue to offer alternatives to people who are unable or unwilling to use digital tools. It is also vital to ensure that we still maintain a “human touch” and empathetic approach, such as offering patients a dedicated point person that they can speak to if they have any questions or concerns.
Leveraging patient insights
One of the most unique aspects of my job is that I am able to leverage my professional experience as an engineer and my personal experience as a three-time cancer survivor that participated in a clinical trial to advocate for patients. In my current role at Medidata, I oversee the company’s Patient Insights Board, which currently consists of nine advocates representing 22 therapeutic areas. By building relationships with patients participating in clinical research, we can design trials in a thoughtful manner, rather than integrating technology that may present barriers for them.
The Patient Insights Board has monthly Design Studio sessions with our design team, creating a structured platform through which the design team and product managers can solicit feedback on the look, functionality and overall experience of solutions they developed. This means we can ensure that all of our patient-facing platforms are effective, efficient and empathetic.
A real moment of validation of the work of our Patients Insights Board came when a designer shared these sessions changed the way he approached his job and how he writes code. Rather than developing whatever made most sense from the back end, he was now actively considering any unintended consequences a coding decision could have on the overall patient experience.
Overall, technology has played a vital role in allowing us to reach a more diverse patient population to participate in clinical research. There is still work to be done, however, in ensuring we use technology to enable patients to feel empowered in their clinical trial journey. Participating in a clinical trial is a huge undertaking for anyone, and even more so for individuals from historically underrepresented groups and those facing financial hardships. By integrating technology as seamlessly as possible into trial design, and using it to engage populations who have not previously participated in clinical research, we can ensure that the treatments we produce are more effective, better quality and better-targeted for the patients who need them.
Alicia Staley
Alicia Staley is Chief Patient Officer at Medidata, leading the Social Impact and Engagement teams to amplify patient, site, and employee insights across the product lifecycle. A three-time cancer survivor, Alicia uses her personal experiences and empathy to champion patient-centric innovation.
