Decentralized Clinical Trials: How to Improve Inclusivity

Sidekick's Clinical Analyst, Leen Hashem, discusses her recently published paper on decentralized clinical trials.

July 5, 2022

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In conversation with The Sidebar, Leen Hashem – Clinical Analyst at Sidekick Health – discussed her recent paper on opportunities and counterintuitive challenges in participant recruitment in decentralized clinical trials. The study addresses the issue of representation in clinical trials and considers how developments in technology could contribute to encouraging inclusivity.

Welcome to The Sidebar, Leen! Could you tell us a bit about yourself?

Very happy to be here! I am a Clinical Neuroscientist (BSc, MSc) by education and a Clinical Analyst by profession. Since leaving academia, I’ve worked exclusively in the digital health space to understand how digital therapeutics (or DTx) can be used to address different challenges in the management of chronic health conditions. This could entail answering questions like, “how can we ease the burden of epilepsy symptoms for patients using non-pharmacological (mainly, digital) interventions?”

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You recently had a paper published on the opportunities and challenges for decentralized clinical trials to broaden participant inclusion. Could you tell us a little more about it? Was there something specific that prompted this study?

Across the digital health ecosystem, people are developing different, but complementary, products (or services) to advance the use of digital technologies in clinical practice. Decentralized clinical trials (DCTs) have proven to be worthy alternatives to traditional (or site-based) clinical trials.

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DCTs have been shown to be cheaper, quicker, and less burdensome on participants and researchers than traditional trials, but just as robust.

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These operational factors (cost, speed, staff workload) may be particularly appealing to those looking to test the effectiveness of a digital intervention in improving patient outcomes – for example, companies on tight budgets and schedules.

DCTs have also been shown to promote diversity and inclusion by recruiting older adults, Black, Indigenous, and other People of Color (BIPOC), and sexual and gender minority (SGM) people – all of which are crucial to maintaining the generalizability of trial results.

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Because of the recent traction that DCTs have been getting, we wanted to take a closer look at the complex ways in which representation has been achieved in these remote trials. Our main finding was that, when viewed through an intersectional framework, improving recruitment in one demographic dimension (e.g., race) can have unintended consequences on others (e.g., education level).

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This is a counterintuitive challenge in DCTs that can again compromise the generalizability of trial results, but we conclude by introducing a number of ways in which researchers can adapt DCT approaches and generate reliable evidence.

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These include involving diverse groups in the study recruitment strategy and developing post-trial communication strategies to maintain relationships with different communities (as well as offering them future opportunities to participate).

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Following these findings, what would you say are the main factors that influence the lack of representation in clinical trials?

Less than 5% of eligible individuals participate in clinical trials, and this percentage is even lower for older adults and racial and ethnic minorities. Here, the lack of representation is a systemic issue.

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Eligible participants typically face an intersectional suite of barriers to participation, caused by a combination of institutional and societal forces.

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For example, researchers are often under immense pressure to recruit a minimum number of participants under heavy time constraints, making participant diversity and inclusion a trial afterthought.

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For participants, barriers to participation include low levels of research awareness, mistrust of medical institutions, access to neither a smartphone or the Internet, and childcare and family caring responsibilities – all being unique challenges which disproportionately affect underrepresented participant populations.

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What are some of the main ways in which decentralized clinical trials could promote inclusivity?

Although we describe a suite of barriers to trial participation, there are also opportunities for researchers to adopt/adapt DCT approaches and improve participant inclusivity.

Firstly, and although this applies to both site-based and decentralized clinical trials, we propose that defining diversity and inclusion metrics before study initiation will improve participant representation.

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We also identify several opportunities for DCTs to enhance inclusivity in both the operational and closeout phases of a trial, including the use of digital channels for participant recruitment and the implementation of electronic patient reported outcomes (ePROs) for participants to complete questionnaires remotely.

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These opportunities, and others, reduce trial burden on the participant, for example by decentralizing the study visits for more convenience.

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How do you see digital therapeutic programs, like the ones offered by Sidekick Health, having an impact on patient inclusivity?

There is incredible potential across the digital health ecosystem to improve patient inclusivity in clinical research.

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At Sidekick, we find that combining elements of DTx and DCTs in our clinical trials would allow us to impact patient inclusivity in several ways, one of which is by reaching a wider audience of participants.

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For example, implementing ePROs, surveys, and electronic diaries in our solutions would reduce the need for participants to travel to and from trial sites to complete outcome assessments. This, in turn, could incentivize individuals with childcare and family caring responsibilities to participate in clinical research.

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Additionally, using electronic informed consent (or eConsent) would allow us to better communicate with eligible participants. For example, video vignettes could be used together with the digital consent form to explain study details in an engaging format. This could particularly appeal to non-native language speakers or individuals with low health literacy, and may improve eligible participants’ trust in clinical research.

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Ultimately, we believe that evidence-based interventions, in order to be effective for everyone, should be built on evidence gathered from representative trials – which is why participant inclusivity is a top priority.

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