Introducing the first issue of Diversity and Inclusion: Unity in Clinical Research

I don’t know about you, but I am inundated with articles, press-releases, events, reports, and such about diversity and inclusion in clinical research. It can be a little overwhelming. So… I thought, why not start a weekly newsletter where I will summarise some of the key pieces of media released, so you can get easy access to:

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My mission, is to create an environment where we are all collaborating to push the clinical research industry forward to make it more diverse and inclusive,

Whether you're an ally, or working in clinical research, or simply someone looking to expand your knowledge, we've got something for you.

So, grab your favourite beverage, find a comfy spot, and dive into this week’s edition. We promise it'll be worth your time!

Regards,

Ash.

Community engagement: The key to successful patient recruitment in clinical trials

The efficacy of a clinical trial hinges largely on its ability to recruit the right patients. Dr. Ken Ho of the University of Pittsburgh Medical Center (UPMC) stands as a testament to this. With a decade-long commitment to Pittsburgh's community, Dr. Ho has been at the forefront of efforts to address and prevent HIV. His collaborations span across esteemed entities like Allies for Health and Wellbeing, Jewish Healthcare Foundation, Shepherd Wellness Community, Project Silk, and AIDS Free Pittsburgh.

For Dr. Ho, trust is the bedrock of patient recruitment. He underscores the value of being an active presence at community events, ranging from health fairs to pride celebrations. Such involvement, even if passive, resonates with the community, signalling genuine commitment and concern.

Given the shadows of past unethical research undertakings, like the Tuskegee Syphilis Study, it's no surprise that many are wary of participating in research. Addressing these apprehensions head-on, Dr. Ho has championed "townhall" meetings. These platforms allow the community to engage directly with researchers and clinicians, fostering trust and bridging divides.

Dr. Ho highlights the pivotal role of community perception in recruitment. He recollects how the PrEP clinic saw a surge in attendees, largely due to positive word of mouth. While monetary compensation can be an incentive, for many, the driving force is the belief that their participation can uplift the community.

Engaging healthcare providers can be a game-changer in recruitment. Dr. Ho posits that patients are more inclined to trust their familiar providers over unfamiliar sponsor representatives. This trust, when harnessed collaboratively by sponsors, can amplify recruitment efforts.

Research registries, where potential participants can access information about pertinent studies, also hold promise. Providers can tap into these registries, reaching out to interested individuals to provide clarity and address queries.

However, the clock is a challenge. In a healthcare landscape dominated by productivity metrics, providers often find themselves pressed for time. Dr. Ho advocates for a more relaxed approach, allowing providers ample time to elucidate study goals and benefits, leading to enhanced community engagement and recruitment.

Effective community engagement isn't a passive endeavour. It demands researchers to invest time, be receptive to concerns, and foster trust through transparent communication. Dr. Ken Ho's journey underscores the profound impact of community engagement, trust cultivation, and open dialogue in bolstering patient recruitment for clinical trials.

For a deeper dive into Dr. Ho's insights and experiences, you can explore the full article here: Improving Recruitment through Community Engagement - A Clinical Leader Perspective .

Barriers to inclusive clinical trial enrolment due to consent document translation costs

The United States is undergoing a demographic transformation. The proportion of non-Hispanic white residents is on the decline, while immigration from Asia and Latin America is on the rise. This shift has led to a notable increase in residents who speak languages other than English at home. This evolving landscape underscores the urgency to address the challenges faced by those with limited English proficiency, especially when it comes to their participation in clinical trials.

Informed consent is the cornerstone of ethical clinical trials. The FDA, recognising the importance of this, mandates that consent documents be presented in a language that the patient understands. They also recommend that these critical documents undergo translation by qualified professionals. But is this always the case?

A comprehensive study at the UCLA Jonsson Comprehensive Cancer Centre delved into this very issue. Over a span of six years, they assessed data from all consent events. This data encompassed patients' primary language, their proficiency in English, and the language in which the consent documents were presented.

The study aimed to discern potential disparities between industry-sponsored and non-industry-sponsored studies. The findings were telling. Non-industry-sponsored studies, despite having more consent events, were less likely to offer translated consent documents. Interestingly, the same patients often had different experiences with industry and non-industry studies, suggesting that the patient population wasn't the variable at play.

While industry-sponsored studies typically have a therapeutic intent, non-industry-sponsored ones often delve into areas like biobanking and quality of life. The latter areas underscore the importance of diverse patient inclusion. The study's findings raise red flags about the quality and clarity of information provided to those with limited English proficiency.

The NIH policy is clear: costs should not be a barrier to participation. Yet, the reality seems to be that non-industry-sponsored studies often lack the resources for translation.

The cost of translating consent documents, particularly in non-industry-sponsored studies, appears to be a significant hurdle for patients with limited English proficiency. As the U.S. continues to embrace its multicultural and multilingual identity, it's imperative to address this barrier head-on.

For a more detailed exploration, you can read the full study here: Nature's Article on Clinical Trials .

The diversity gap in Alzheimer’s clinical trials: A matter of equity and science

Recent approvals of Alzheimer’s drugs have spotlighted a glaring issue: the underrepresentation of Black and Hispanic individuals in clinical trials. Take the drug lecanemab, approved in July 2023. Despite Black and Hispanic individuals being up to twice as susceptible to Alzheimer’s compared to their white counterparts, they constituted a mere 20% of the trial participants. The scenario is even more pronounced with donanemab, where less than 10% of participants hailed from diverse backgrounds. To add, in the trial steered by Eli Lilly, only 19 Black participants were administered the drug.

This disparity isn't just a statistical concern; it's a matter of safety and efficacy for diverse populations. One pivotal reason for this skewed representation is the amyloid protein requirement. To be eligible for trials of drugs like lecanemab and donanemab, participants need to exhibit sufficient levels of this protein, a hallmark of Alzheimer’s. Research has illuminated that diverse populations often fall short of this criterion.

Other impediments to equitable participation encompass:

• Proximity to well-equipped hospitals.
• Recruitment campaigns that might inadvertently bypass diverse communities.
• A higher incidence of disqualifying health conditions among Black and Hispanic people.

While lecanemab and donanemab have demonstrated potential in mitigating cognitive decline, they're not without their share of concerns. Potential adverse effects, such as brain abnormalities, underscore the importance of understanding these drugs' impact across diverse populations.

The diversity deficit in these trials transcends equity. It's a scientific imperative. A homogenous participant pool might stymie our understanding of Alzheimer’s and its various manifestations across different ethnicities.?

For an in-depth exploration of this pressing issue, you can peruse the full article here: Nature's Insight on Alzheimer’s Drug Trials .

Driving diversity in clinical trials: A strategic approach

The FDA has been proactive in advocating for clinical trials that mirror the diverse population, primarily by expanding enrolment eligibility criteria. Yet, there's still a gap in ensuring that underrepresented groups are both accessible to and actively enrolling in clinical studies.

To achieve truly diverse and equitable clinical trials, a well-thought-out strategy is essential. This means diving deep into understanding the patient community and forging meaningful partnerships.

A significant 85% of cancer patients get their treatment from community sites, which are typically set up for clinical research. These sites are more localized, not being directly tethered to a hospital system or an academic medical center (AMC). Collaborating with these community sites can be a game-changer in enhancing diversity in clinical research.

The Just in Time (JIT) activation of clinical trials offers a promising avenue. Here, a trial is swiftly activated for a patient in a specific locale, often within a fortnight. This model is particularly advantageous for community sites.

Decentralized Trial (DCT) models further the cause by enabling trials to be conducted closer to patients' residences. This approach breaks down geographical barriers, ensuring that participation isn't confined to select research hubs.

Mirati Therapeutics recently unveiled a collaboration with the Sarah Cannon Research Institute (SCRI) to bolster diversity in clinical study recruitment. This alliance is laser-focused on dismantling barriers that hinder clinical study participation.

For organisations to effectively rope in diverse participants for clinical trials, there's a need to put diversity and representation at the forefront. This entails actively engaging with investigators, community sites, patients, and wholeheartedly embracing Diversity, Equity, And Inclusion (DEI) principles.

Mirati Therapeutics has seamlessly woven DEI into its corporate blueprint, even establishing a Clinical Trial Diversity Task Force. This task force champions the cause of including a varied patient demographic.

For a comprehensive dive into this topic, you can explore the full article here: Diversifying Clinical Trials: A Clinical Leader Insight .

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