Site location, community reflective advertising, translation of study materials and social media outreach among the top methods
NEW YORK, May 2, 2024 /PRNewswire/ — Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, announced the results of a study examining the motivators and deterrents of clinical trial participation among ethnic minorities. The research paper, published in MedRxiv, outlines strategies sponsors can utilize to minimize deterrents and promote diversity in their research.
Lindus Health partnered with the University of Oxford in a collaborative effort to conduct a qualitative study aimed at investigating perceptions regarding participation in clinical research. The study collected data from both research professionals and the general population through eSurveys, meticulously crafted with guidance from the Enhancing Diversity in Clinical Trials (EDICT) advisory committee. Additionally, focus groups were conducted with members of the general population who were provided with preparatory educational materials beforehand then later invited to share their perspectives on engaging in clinical trials, with a particular focus on distinguishing between early phase and later phase research. To ensure a diverse representation in the study cohort, social media recruitment strategies were also employed.
While the majority of respondents of the general population surveys had never engaged in clinical research to date, Black individuals reported to be more willing to participate in a trial (including early phase research) than Asian. The top three barriers to participation overall, regardless of study phase, included safety and health concerns, time investment, and lack of support. Regarding early phase studies, Black respondents cited lack of trust as a top concern for participation.
Another key takeaway is that nearly half of researchers did not implement strategies to promote diversity in their study cohorts across all phases, with a higher percentage in early phases (62.5%). For those who have leveraged tactics to encourage diversity, the most common strategies included location of study sites and advertisements to recruit ethnic groups, translation of study materials, and social media use.
Underrepresentation of Black, Asian, and other ethnic minority groups has been a long-standing problem within clinical research. Most efforts to boost diversity have been implemented in Phase III and IV studies with little focus on early phase research. Failure to assess safety and efficacy of investigational products for these populations in Phase I and II places these individuals at a potentially higher risk of adverse effects and ineffective treatment, ultimately diminishing their clinical utility.
“Diversity in clinical trials isn’t a nice to have, it’s a medical necessity. Yet too often in Life Sciences clinical trial diversity is an afterthought and not properly linked to strategies that will make a difference,” said Lindus Health co-founder Michael Young, who was directly involved in the execution of this study. “This research provides specific and tangible recommendations that are relevant to any trial.”
In the US, the FDA does not explicitly mandate diversity in clinical trials for market approvals, however it has issued several guidelines and recommendations to ensure that data is applicable for all populations who should benefit from a therapeutic intervention.
“Clinical trials are not always designed to address barriers to participation for all, and there is a lack of research on how to promote engagement in minority groups,” said Duncan Richards, Professor at the University of Oxford, who collaborated on this study. “Our study with Lindus Health aims to help fill this gap by lending insights on the motivators and deterrents for engaging in interventional research across various ethnic groups in early and late stage research.”
The full manuscript can be found here: https://www.medrxiv.org/content/10.1101/2024.04.04.24305355v1.full-text
About Lindus HealthLindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. Lindus Health does this thanks to a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), marrying a world-class clinical operations team with its unique software platform, and access to 30 million Electronic Health Records. Clinical trials are the biggest bottleneck to advances in healthcare and by removing this constraint they aim to improve health for everyone. They handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.
To date, Lindus Health has delivered more than 90 trials across the US, UK, and Europe to tackle a range of conditions including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia.
The company was named after James Lind, who pioneered the first clinical trial and treatment for scurvy, and co-founded by Michael Young, a former Special Adviser to the UK Prime Minister on Life Sciences, and Meri Beckwith, a former life sciences investor.
Lindus Health has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.
About the University of OxfordOxford University has been placed number 1 in the Times Higher Education World University Rankings for the eighth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer.
Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions.
Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. Over a third of these companies have been created in the past five years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs.
Media Contact:Jodi Perkins
Amendola for Lindus Health
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SOURCE Lindus Health
