Seeking a cure for racial disparities in drug trials
The pharma industry is seeing the importance of including people from different backgrounds in medical research (1,400 words, 6.5 minutes)
In the high-stakes world of pharmaceutical research, where a single clinical trial can cost hundreds of millions of dollars, a stark reality is coming into focus: For too long, the participants in these trials have skewed heavily white, male and affluent, rendering many of the resulting drugs ineffective or even dangerous for large swaths of the population. Now, under mounting pressure from regulators, advocacy groups and their own scientists, drug makers are scrambling to diversify the ranks of clinical trial volunteers. From Big Pharma conglomerates to fledgling biotech startups, companies are overhauling their recruitment strategies and partnering with community organizations to enroll more women, racial minorities, older adults and lower-income groups.
One stimulus for this heightened awareness may have been the Covid-19 pandemic when a study published in the Journal of Racial and Ethnic Health Disparities revealed the unequal impacts of the virus across different racial and ethnic groups.
An article in the New England Journal of Medicine notes that clinical trials have historically underrepresented minority groups, leading to gaps in data on how treatments affect these populations. For example, Black Americans make up 13% of the U.S. population but account for approximately 9% of clinical trial participants, according to a 2024 study in the International Journal of Environmental Research and Public Health. A consensus study report conducted by the National Academies of Sciences, Engineering and Medicine found that this disparity can result in treatments that are less effective or have unforeseen side effects for underrepresented groups and can lead to delayed diagnoses.
Efforts to rectify these imbalances are underway. In November 2020, the U.S. FDA issued a guidance document to enhance diversity in clinical trials and urged sponsors to increase enrollment of underrepresented populations in their clinical trials. Companies such as Pfizer have implemented initiatives to do just that. In Pfizer’s Covid-19 vaccine trials, for example, approximately 10% of U.S. participants were Black, and 13% were Hispanic or Latino.
An article in the Journal of Clinical and Translational Science notes that community engagement strategies produce more equity in clinical research and could go a long way in fostering trust and participation among underrepresented groups. For instance, the All of Us Research Program, led by the U.S. National Institutes of Health, is gathering health data from one million diverse participants in the U.S. By collaborating with community organizations, the program has recruited a diverse participant pool that reflects diversity in the U.S., paving the way for more inclusive and representative research outcomes.
Technology is also critical to enhancing diversity in clinical trials. An article in the Journal of mHealth notes that virtual clinical trials can mitigate geographic and mobility barriers that often prevent minority populations from participating in traditional trials. Virtual and decentralized trials facilitate recruitment in underserved or remote areas that frequently lack access to study sites. The authors note that virtual trials could help overcome language barriers and other communication issues.
THIS WEEK 06/04/24
AstraZeneca announced capivasertib (Truqap) in combination with fulvestrant is now available in Canada for the treatment of adult female patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.
Johnson & Johnson inked a deal with Numab Therapeutics to acquire global rights to NM26, a Phase 2-ready investigational, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis.
The U.S. FDA approved Moderna’s mRNA-1345 (mRESVIA), a mRNA respiratory syncytial virus (RSV) vaccine, to protect adults 60 years of age and older from lower respiratory tract disease caused by RSV infection.
The U.S. FDA okayed Tris Pharma’s clonidine hydrochloride (Onyda XR) for Tx of ADHD as a monotherapy or as an adjunctive Tx to approved CNS stimulant medications in pediatric patients six years and older.
LISTEN UP
In season 12 of the NPC Podcast, Brian Bloom, CEO of Bloom Burton & Co., gives insights into changes in the Canadian Healthcare investment landscape, the return of the generalist investor, and the rise of consumer empowerment in healthcare. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. In Healthbiz Rewind, you’ll read bold life sci predictions made during the renowned “Prognostication Korner” segment of the NPC Podcast.
Bettina Hamelin
President
Innovative Medicines Canada
Toronto
Season 03, episode 05
Listen to this episode here
What does the future hold for genomics research in Canada? (This episode was recorded in March 2021, when Hamelin was President & CEO of Ontario Genomics)
I think the Coronavirus has brought forward that science, genomics and data are the most important sciences going forward. I feel incredibly privileged to be right in the midst of it, to be able to facilitate a better understanding of genomes and organisms, whether it’s viruses or humans or other living things. There is a very interesting report that was published by McKinsey last year, it’s titled ‘The Bio Revolution’. That report illustrates an opportunity, or a prediction, that by 2030 to 2040, about 60% of the inputs into the economy will be biological, and the root of that is genomics, proteins, modification of proteins and what we can do with microorganisms. We can put all kinds of genes in yeast and use fermentation as we used for breadmaking or winemaking, but now we make it to make products, drugs, biotherapeutics, bioproducts, fabrics, etc., that we need.
In advanced biological approaches, we will continue to spark, support, and nurture genomics research in the health sector. The pandemic has shown us that other supply chains are at risk and can benefit from genomics. I see genomics research providing solutions for healthier people, but also a healthier environment to combat climate change and deal with the pollution we are creating around ourselves. So, it’s an incredibly bright future ahead of us, and we’re right in the midst of it.
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