What if “patient-centricity” in clinical trials is more about perception than reality?
On January 9th, 2025, Derk Arts (CEO of Castor) and Brad Hightower (CEO of Hightower Clinical) explored this idea during a LinkedIn Live discussion, addressing a recent hotly debated topic on LinkedIn: balancing patient-centricity with scientific rigor. The discussion examined whether prioritizing patient experience risks undermining the core purpose of clinical trials and offered practical insights into designing ethical, effective, and efficient research protocols.
If you missed the live conversation, the full discussion is available for replay—offering unfiltered perspectives on one of the industry’s most pressing challenges.
Clinical Trials: Protocol-Centric by Design
The conversation began with a direct assertion: clinical trials are about the protocol, not patient care. While patient-friendly practices can improve engagement and enrollment, Brad Hightower cautioned against framing trials as care options.
“We’re following a protocol. That’s what trials are for,” Brad explained. “We can make trials more accessible, but we can’t blur the line between research and treatment.”
This distinction is crucial. When trials are marketed as “patient-centric,” participants may develop a “therapeutic misconception”—believing they will personally benefit, even in placebo-controlled studies. Such misunderstandings risk eroding trust in clinical research and diminishing the informed consent process.
Burden Reduction: A Strategic Imperative
While trials shouldn’t be misrepresented as care, reducing the burden on patients and sites remains critical to their success. Derk Arts highlighted tools like eConsent as examples of solutions that simultaneously improve patient understanding and site efficiency.
“Informed consent isn’t a checkbox,” Derk noted. “It’s a process to ensure participants truly understand the commitment they’re making.”
Brad shared that patient-friendly protocols often attract higher enrollment and retention rates. For example, trials with manageable visit schedules and intuitive digital tools are easier for participants and more efficient for sites to implement.
Are We Overselling Patient-Centricity?
A recurring theme was whether the industry’s focus on “patient-centricity” has been taken too far? Both Derk and Brad expressed concerns about overpromising benefits to participants.
Brad shared a particularly stark example:
“I’ve seen patients in placebo-controlled trials who didn’t understand they might not receive treatment. One participant’s condition worsened severely because of this misconception. That’s not ethical.”
The takeaway? Trials should be accessible and transparent—but never misrepresented as direct care options.
The Problem with Overly Narrow Criteria
Eligibility criteria emerged as another key challenge. Brad explained how overly restrictive inclusion/exclusion criteria hinder enrollment, even in specialized clinics.
“If a migraine clinic sees 1,000 patients but none qualify for a migraine trial, the protocol is the problem,” Brad said.
Derk agreed, emphasizing that protocols designed for narrowly defined populations often fail to reflect real-world demographics. This disconnect not only delays enrollment but also limits the applicability of trial results.
Collaborating Through Platform Trials
One potential solution to these challenges is platform trials, which test multiple interventions under a shared protocol. Derk shared his experience working on adaptive platform trials during COVID-19, where this model reduced redundancy and allowed for more efficient data collection.
“Platform trials make it easier to compare interventions and reduce competition over limited patient populations,” Derk explained.
However, adoption remains slow due to the pharmaceutical industry’s preference for retaining control over trial design and outcomes.
Incremental Improvements, Not Silver Bullets
The session concluded with a reminder that clinical research is inherently complex. Both Derk and Brad emphasized the importance of focusing on small, meaningful improvements—rather than chasing industry buzzwords or quick fixes.
“There’s no magic solution,” Brad said. “This work is hard, and it should be. Our job is to make incremental progress while staying true to the scientific process.”
Derk echoed this sentiment:
“We can’t lose sight of the fundamentals—clear communication, streamlined processes, and respecting the protocol. That’s how we make trials ethical and effective.”
Key Takeaways
- Science First: Trials are about answering scientific questions, not delivering care.
- Transparency Matters: Clear communication reduces misconceptions and builds trust.
- Practical Design Wins: Reducing burden improves enrollment and retention while respecting scientific rigor.
- Collaborate for Efficiency: Platform trials offer a promising path to innovation.
Watch the Full Discussion
Missed the live conversation? You can watch the full replay of this insightful discussion between Derk and Brad on LinkedIn. Discover actionable strategies for improving trial design, debunking misconceptions, and navigating the challenges of modern clinical research.
Click here to watch the LinkedIn Live replay now.
This discussion underscores the need for a balanced approach to clinical trials—one that respects the protocol while prioritizing transparency and accessibility. By focusing on incremental progress and ethical practices, the industry can create a research ecosystem that benefits both science and society.