Sponsors and provider organizations understand that patient- and site-centricity are critical for a robust clinical trial industry. But they often fail to achieve it.
WCG Avoca’s 360° Assessment of the Clinical Trial Industry Survey explored this disconnect between what research-naïve patients and investigators want and the ways in which sponsors currently conduct research.
Wary Patients, Enthused Participants
The survey findings revealed that 75% of potential patient respondents (representing a cross-section of the US population) had no direct relationship to a clinical trial: They’ve never participated in one, and they don’t know anyone who has.
They are wary. Presented with the statement “I believe clinical trials only benefit the pharmaceutical companies that run them,” 36% agreed, 36% disagreed, and 29% were neutral. Now, contrast that to the experience of actual participants:
- 80% said they had a good relationship with the healthcare professionals who provided treatment during trial,
- 85% said that the time spent was worthwhile, and
- 90% said that they would definitely or probably participate in a trial again.
Actual trial participants react favorably to their experience, but there’s ultimately a lack of awareness among the broader population — a disconnect between the perception of participating in a clinical trial and the reality.
How do we foster trust in the trials? It begins by educating people about trials in the same way they are educated about a newly marketed drug. Listen to concerns, address misconceptions, and respond to questions. The best answer begins something like this: “That’s a great question. Let me help you understand this a little bit better.”
Many sponsors have had great success with a patient advisory board. It provides first-hand insights on a disease and its effects from the people who are living with it. These can inform protocol design and execution, leading to simpler protocols, more targeted designs, and true patient-centricity.
Sites Perspectives Often Ignored
Site staff that were surveyed want to be part of clinical research, but they need sponsors and CROs to listen to their perspective.
They agree it is a valuable experience, one they’d repeat: 94% said they would definitely or probably participate in a clinical trial again, and 84% agreed that time spent participating in clinical trials is worthwhile.
And they are working on trials to do good: Almost all site respondents cited a desire to contribute to the advancement of science (96%) and the ability to bring new or better treatments to patients (95%).
But they feel overlooked and overburdened. Although 65% of site staff responding to the survey agreed that sponsors design trials in a patient-centric manner, only 15% strongly agreed that sponsors take sites into consideration when designing protocols.
Among the most pressing issues, from the site perspective:
- Protocol clarity: Only 38% strongly agreed that the protocol was “clear & easy to follow.”
- Compensation: Only 27% strongly agreed they were “compensated fairly & on time.”
Sites want to be asked for their feedback, and they want sponsors to act on it. Some of the respondents were quite adamant about this:
“ASK SITES FOR INPUT ON YOUR PROTOCOL. You are NOT an expert at boots-on-the-ground enrollment. Ask someone who is.”
and
“Put clinical trialist physicians, nurses, and pharmacists in charge of the research divisions with sufficient authority to run them properly. It’s clear that the companies are too interested in the financial aspects and care too little about the science or patient care aspects of pharmaceutical research.”
It’s not that sponsors don’t seek site feedback. Rather, they are likely to be talking only with key opinion leaders at large academic centers. As the industry moves toward setting up de novo sites and bringing in more community centers, we need to know what is operationally feasible for them.
Knowing this during protocol development can reduce amendments later. Avoidable amendments — such as those that address protocol inconsistencies and impractical execution instructions — can be costly; eliminating even one substantial amendment can save millions and significantly reduce timelines.
Across the Entire Trial
Many sponsors will seek feedback from those already familiar with the clinical trial industry. But as the survey reveals, they need to broaden their horizons and attend to the needs of research-naïve participants and investigators to expand the patient pool.
To be successful, clinical research must be reimagined from the perspective of those closest to it. The future of effective trials lies in the ability to actively listen and respond. Only then can barriers to enrollment, retention, and recruitment be accurately identified and broken down in order to accelerate clinical research.
To discover more insights from patients, sites, sponsors, and providers – download the 2023 Avoca State of the Industry Report.