Enhancing diversity in clinical trials
Regulatory frameworks are driving measurable progress toward more inclusive participant representation(Issue #337, 1,406 words, 7 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
The landscape of clinical trials in 2025 is undergoing a major transformation as regulatory bodies implement concrete diversity requirements to boost the representation of historically underrepresented populations in research. The U.S. FDA’s June 2024 Diversity Action Plan (DAP) draft guidance requires sponsors to define enrollment goals by race, ethnicity, sex and age, and to present strategies to achieve those targets as part of Phase III or pivotal study protocols. Although this guidance remains in draft, the FDA also provides documents for sponsors and clinical research sites to meet these objectives. At the same time, the World Health Organization has called on countries and research groups to make inclusivity a core part of how clinical trials are run, encouraging them to follow its guidance on recruiting diverse participants and building more inclusive research systems.
Industry leaders are also implementing a range of real-world strategies to improve diversity in clinical trials. For example, a 2022 report from the Pharmaceutical Research and Manufacturers of America (PhRMA) details how Genentech launched the Advancing Inclusive Research Site Alliance to partner with research centers in communities with larger Black and Hispanic/Latinx populations. The initiative focuses on building long-term relationships and testing recruitment approaches that support more inclusive enrollment. The same report highlights that Novo Nordisk is leveraging decentralized trial models and telemedicine to reach broader patient populations, while refining study materials and support tools based on feedback from diverse participants. Meanwhile, a case study from the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard explains how Boston Scientific applies systematic, data-driven methods to set and track diversity goals in cardiovascular trials, adjusting site selection and community engagement based on ongoing analysis.
Engagement with communities is central to sustained progress, with alliances forming between sponsors, academic institutions, and local organizations. The All of Us Research Program aims to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all. The program uses community-based outreach and culturally tailored engagement models. The PhRMA report notes that Sanofi has established a clinical trial inclusion and diversity team responsible for benchmarking race and ethnicity enrollment data. This initiative trains staff in cultural competency and collaborates with historically Black colleges and universities as part of multi-sponsor initiatives. Together, these examples reflect a growing shift across the industry to embed inclusivity into trial operations in lasting, measurable ways.
Therapeutic case studies underscore the real-world necessity for inclusion. A study in Frontiers in Cardiovascular Medicine found that differences in genetic ancestry and ethnicity can influence response to treatments such as bucindolol and clopidogrel, with variations in efficacy and safety linked to genetic variants more common in certain populations. In many cases, limited diversity in clinical trials has delayed recognition of these differences. The review also noted that the development of PCSK9 inhibitors was accelerated by the identification of protective genetic variants prevalent in specific ethnic groups, illustrating how underrepresentation can slow the pace of discovery and limit the reach of innovation. Tracking these differences over time may help build the case for stronger inclusion strategies in research and regulation.
Technology is increasingly recognized as essential in reducing logistical and socioeconomic barriers. Dr. Michel van Harten, CEO of myTomorrows, said in an interview with Applied Clinical Trials that AI-driven tools are helping expand access to clinical trials by supporting patient identification across broader demographics, streamlining trial matching, improving site selection, and simplifying complex materials such as consent forms, particularly for individuals with low health literacy or limited English proficiency.
According to LifeBit, decentralized trial designs and remote monitoring are especially impactful for rural patients and those facing transportation constraints, accelerating both recruitment and the democratization of participation. This is demonstrated by a rural South Carolina obesity study, which achieved 10 to 15 times faster enrollment than traditional clinical trial recruitment methods through targeted digital recruitment, and a National Institutes of Health (NIH) migraine trial, which completed recruitment four times faster than expected by adopting a remote-first approach and e-consent technologies.
THIS WEEK 07/22/25
The Chronicle team extends our sincere condolences on the passing of Michael Cels. A respected leader in the pharmaceutical industry, Mike made lasting contributions through his work at GlaxoSmithKline and Bayer. In recent years, he became a tireless advocate for ALS awareness, using his voice to support others even as he faced the illness himself. He will be remembered for his integrity, leadership, and resilience. Our thoughts are with his family, friends, and colleagues.
Health Canada has approved Merck’s pembrolizumab (Keytruda), an anti-PD-1 therapy, in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.
Biocon Biologics announced that the U.S. FDA has approved Insulin Aspart-xjhz (Kirsty), a rapid-acting human insulin analog, as an interchangeable biosimilar to NovoLog (Insulin Aspart) to improve glycemic control in adults and pediatric patients with diabetes mellitus.
Health Canada has approved Eli Lilly’s mirikizumab (Omvoh) for the treatment of adult patients with moderately to severely active Crohn’s Disease who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment.
Call for nominations for the Canadian Healthcare Marketing Hall of Fame
Nominations are now open for the 2025 Canadian Healthcare Marketing Hall of Fame, which honours individuals who have made a lasting contribution to the field of healthcare marketing in Canada. Established to recognize professionals whose work exemplifies leadership, integrity, and impact, the Hall of Fame highlights those who have demonstrated extraordinary commitment to the humane principles inherent in our profession and made a lasting impact on others.
Inductees will be honoured at the 23rd Annual Canadian Healthcare Marketing Hall of Fame Ceremony, held during the 19th National Pharmaceutical Congress on November 4, 2025.
To view past recipients and submit a nomination, visit the Canadian Healthcare Marketing Hall of Fame.
This is an opportunity to recognize excellence in healthcare marketing and celebrate those who have shaped the profession.
NOW, LISTEN UP: Sobi Canada’s Bob McLay: Life Science Leadership in Rare Disease
In Season 14 of the NPC Podcast, Bob McLay, General Manager of Sobi Canada, gives insights into stewarding rare drug therapies, KOL advocacy and the future of preventative medicine. 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. You can listen to the podcast here.
Patrick Massad
Commissioner
Pharmaceutical Advertising Advisory Board (PAAB)
Toronto
Season 01, episode 06
Listen to this episode here
What are the big advertising or marketing changes to healthcare practitioners? (This episode was recorded in August of 2020)
We’ve seen some substantial changes in Covid-19, both quantitatively and qualitatively. Quantitatively, there’s been a 35 per cent increase compared to last year in email and internet-type advertising within promotional systems divisions, which is a sizable growth. This has driven qualitative changes as well, particularly in terms of segmentation. Segmentation tends to be easier in a digital forum, leading to higher submission volumes. Our reviewers are very busy right now. We’re seeing more segmentation from both a demographic and a value-graphic point of view.
At the start, closer to April, companies were mostly just digitizing print pieces and sending them out via email. Now, we’re seeing more of a digital-first approach. There’s more focus on questions like, ‘How are we going to segment? What variable fields are we going to apply to quickly target based on A, B, or C?’ This shift has affected our volume, the amount of work we’re doing, and many other areas.
NEXT WEEK
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