What Experts Think Will Happen With Patient Centricity In 2024
As told to Abby Proch, executive editor of guest columns, Clinical Leader
Heading into 2024, as with any annual flip of the calendar, we anticipate there will be things that will fade away, things that will persist, and things that will develop — in the clinical research industry as in life. And so, when Clinical Leader asked experts across the continuum about their thoughts for the new year, we got a little bit of everything. Many people opined on the pervasiveness of AI, whether that’s in patient recruitment or regulatory oversight, a few acknowledged the persistence of the decentralized trial in all its many forms, and others saw gains and changes coming in their own therapeutic areas.
In part two, experts discuss patient centricity themes, including diversity, equity, and inclusion (DEI) and precision medicine, in the clinical trials industry as we move into 2024.
Charlie Paterson, clinical development expert and associate partner, PA Consulting
Diversity and inclusion initiatives will continue to grow in importance, as trials need to better reflect real-world populations. More efforts will be made to recruit and retain diverse participants, to improve trust in trials and also accessibility by building beyond translation, and to provide much more culturally tuned resources.
Patient-centric trial design, too, will remain in focus as organizations drive to offer more flexible, convenient, and accessible trials to reach more diverse populations. As options expand for trial participation, with hybrid, virtual, and decentralized study models growing in popularity, sponsors, sites, and CROs will compete to be study providers of choice.
Finally, personalized therapies tailored to the individual characteristics of each patient, such as their genetic profile, biomarkers, or disease subtype, have the potential to improve the efficacy and safety of therapies, as well as reduce the cost and waste of ineffective treatments. However, they also pose challenges for the design and conduct of clinical trials, which traditionally rely on large and homogeneous patient populations to demonstrate statistical significance and generalizability. Demonstrating the effectiveness and safety of personalized therapies will require innovative trial designs and much more granular stratification of populations as well as the use of new data types and sources to understand potential impact.
Mark Scullion, CEO, Atlas Clinical Research
This year will be marked by a stronger commitment from trial sites to forge deeper connections with their communities. This endeavor is more than just preparing for individual trials; it's about cultivating ongoing, meaningful relationships with diverse groups. Such engagement is critical to ensure trial inclusivity and to reflect a more accurate cross-section of society. The benefits extend beyond ethical compliance; they lead to richer, more applicable research findings. Emphasizing patient diversity is paramount. It's not just about numbers; it's about genuinely understanding and including varied patient experiences and backgrounds. This inclusive approach aids pharmaceutical companies in obtaining data that is more representative of the broader population.
Sabina Kineen, partner and rare disease patient advocate, Clinical Trials For All
One relative newcomer to the industry stage is patient access. We’ve talked a lot about trial diversity and trial equity; we’ve talked about the need for decentralized and hybrid clinical trials, but what these past conversations have been leading us toward is a more focused conversation about patient access — both in terms of healthy patients and patients looking for research as care who reside in geographical locations that are harder to reach. Focusing on accessibility is the next step to solving ongoing trial inequities and improving trial diversity and retention.
Ramita Tandon, chief clinical trials officer, Walgreens
Community-centered research will be the driving force in clinical trials. Sponsors will focus more on strategies to ensure all citizens we serve have access. This means having a deeper understanding of how potential participants wish to be contacted and contribute to trials. The future involves not only meeting patients where they are but also educating them about the valuable healthcare options clinical trials present. This community-centered approach is poised to redefine the landscape of clinical research.
Jennifer Sheller, VP, head of clinical sites, data management & quality, Merck & Co.
In 2024, it will be important for our industry to continue redefining the parameters of diversity in clinical research by extending beyond conventional boundaries and aiming to embrace a diverse and expansive community of participants. A concerted effort is well underway to eliminate access barriers, welcoming people from marginalized racial and ethnic groups as well as those from various socioeconomic backgrounds. A new era of collaboration is emerging, characterized by strategic partnerships and the development of resources to empower research sites. This allows for the elevation of clinical trial awareness and accessibility for a community of patients who have been historically underrepresented in research.
At the core of this strategy lies a shared understanding — collaborative efforts, funding support, and an unwavering commitment to diversity and quality standards, which are indispensable for the sustained vitality of the clinical research industry. The industry is not merely advocating for diversity; it is intricately weaving it into the fabric of clinical trials. Early strategy development and meticulous planning guide these steps, with a deliberate focus on U.S. clinical trial site selection in communities that have higher populations of people who have historically been underrepresented in research. Improving access to and awareness of clinical trials is just one piece of the puzzle; a crucial aspect of this transformation entails strengthening our community relationships to nurture trust and encourage active engagement. This dedication to equitable access paints a picture of a future where the benefits of medical research resonate on a personal level, reaching and transforming the lives of everyone involved.