The DPHARM 2024 conference in Philadelphia convened the brightest minds in clinical research to explore innovations designed to modernize clinical trials and drive greater patient value. Jessica McKenzie Mays, VP of Life Sciences and Katherine Sigg, COT, OSA, OSC, Business Development Associate at 20/20 Onsite, returned with key takeaways that speak directly to the challenges and opportunities in decentralized clinical trials (DCTs), site feasibility, and patient-centric innovations.
Here are their key takeaways from DPHARM:
- Innovation often clashes with budget constraints—standardized feasibility can help bridge the gap.
- Home care visits and wearables should be assessed separately to improve DCT outcomes.
- Address healthcare access by enrolling eligible patients and delivering care to their location.
- Patient-centric designs and collaboration drive better study outcomes.
Below, we explore these insights and what they mean for clinical research going forward.
Addressing Site Feasibility and Innovation
Takeaway: The tension between innovation and budgetary constraints continues to hinder progress. One solution is adopting a unified approach to feasibility standardization.
One of the standout sessions, “Joint Site and Sponsor Session on Innovative Solutions Addressing Site Challenges,” examined how improving site feasibility can positively impact trial efficiency. The current, often overcomplicated feasibility processes create unnecessary burdens on sites. This session posed an important question: "What if there was standardization of feasibility across the industry?" A unified approach like this could reduce site burnout and streamline vendor selection.
Despite widespread recognition of the need for faster, more effective solutions, Mays pointed out a reluctance to allocate resources toward solving these challenges. “We live in a world where better, faster, or rescue solutions usually cost more,” she noted. Clinical trial budgets are typically fixed early, limiting the willingness to invest in problem-solving measures that could save time and resources. This tension between innovation and budgetary constraints continues to hinder progress.
DCTs: Benefits and Limitations
Takeaway: Categorizing in-person home care visits and wearables together when assessing DCTs and patient satisfaction is problematic. One solution is establishing an industry-wide distinction between these categories and evaluating them separately.
Mays also addressed the complexities of decentralized clinical trials, noting that DCT components like wearables, telemedicine, and home health visits are often lumped together under one umbrella. This oversimplification can obscure important distinctions in patient satisfaction. She pointed out that patients are more satisfied with in-person care near home, such as nursing visits or mobile ophthalmic exams, versus more complex technologies like wearables.
Sigg highlighted a keynote by Kenneth Getz, MBA, Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, which demonstrated that DCTs can deliver high returns on investment (ROI) by reducing participant burden and accelerating timelines. However, she stressed that to maximize DCT benefits, patient-centric approaches must be better integrated with innovative solutions catering specifically to each trial design.
Tackling Access and Awareness in Rare Disease Enrollment
Takeaway: Lack of healthcare access remains a significant challenge. One solution is to identify eligible patients, ensure proper study enrollment, and deliver care directly to their point of need.
Access to healthcare remains a significant challenge in rare disease enrollment, a key theme in the rare disease roundtable. Mays noted that while raising awareness about clinical trials is important, it often fails to address the root issue: lack of healthcare access. "Access feeds the awareness pipeline," she explained. Many patients never receive a diagnosis or referral to clinical trials without regular healthcare.
This challenge is especially acute in rare disease trials, where competition for a small pool of patients is fierce. As one panelist mentioned, there are currently 6,000 assets in clinical development, meaning multiple trials often compete for the same limited patient population. With each patient's enrollment potentially making them ineligible for other trials, improving access to care is crucial to ensuring eligible patients are identified and enrolled in the right studies.
Collaborative Innovation for Improved Outcomes
Takeaway: Patient-centric designs and enhanced collaboration can lead to more meaningful results and improved study outcomes.
Collaboration between sponsors, sites, and CROs was another major focus at DPHARM. Sigg attended a presentation on partnerships, where experts stressed the importance of early, clear engagement to drive better trial outcomes. Candice Fitzgerald, Head of CD&O Regions at Boehringer Ingelheim, reinforced that patient-centric designs and collaboration can lead to more meaningful results. Mays echoed this sentiment, sharing that sponsors need to focus on “removing barriers to execution at the ground level."
20/20 Onsite’s Role in Overcoming Challenges
20/20 Onsite already addresses many challenges discussed at DPHARM. Mobile Vision Clinics bring essential eye exams directly to patients, reducing the burden on them. This model accelerates timelines, improves patient retention, and supports diversity in clinical trials.
In addition to easing patient burden, 20/20 Onsite offers solutions that prevent site burnout. Our clinics alleviate workload pressures on site staff, which is especially important in an environment grappling with staffing shortages. We ensure trials stay on track by engaging early with sponsors and sites, even when feasibility or staffing issues arise.
Sigg stated, "We provide patient-centric care and help reduce site burnout, aligning perfectly with the innovative solutions discussed at DPHARM." Our track record speaks for itself, with proven results for sponsors, CROs, and patients alike.
Ready to take the next step? Contact us to learn how we can partner with you to accelerate your clinical trials.