Survey Highlights Need to Listen to the Voices of Research-Naïve Patients and Sites

Listening to Sites and Patients, Part 1

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. In this two-part blog post, we’ll discuss the concerns that sites and patients have expressed and identify ways to address them.

Most sponsors design their protocol, to some degree, on feedback from investigators and participants. However, they typically turn to those already familiar with the clinical trial industry. But as we’ve discovered, they need to broaden their horizons and attend to the needs of research-naïve participants and investigators.

The WCG Avoca 360° Assessment of the Clinical Trial Industry Survey was designed to evaluate the disconnect between what research-naïve participants and investigators want and the ways in which sponsors currently conduct research. It provides critical insights into what motivates participants and investigators to engage in clinical research.

Avoca’s annual industry research typically surveys sponsors and providers to highlight key themes and disconnects within the industry. This year, it took a different approach, looking across all clinical trial stakeholders to identify opportunities for improvement. The underlying question: Why aren’t more people participating?

Combining these findings with those of the WCG CenterWatch Global Site Relationship Benchmark Survey provided even more robust insights. The CenterWatch survey, since 1994, has been collecting feedback from thousands of sites worldwide on what makes a good sponsor and CRO. It rates sponsors and CROs based on 47 attributes across six different categories: overall project support, study monitoring support, protocol/ study design and planning, site management, work style, and contracts and budgets.

Looking at these two surveys together yields a wealth of insights.

Uncharted Territory for Patients

The WCG Avoca survey revealed that 75% of patient respondents (who represent a cross section of the US population), have no direct relationship to a trial. That means they’ve never participated in a clinical trial, and they don’t know anyone who has.

So, what prevents someone from participating in a clinical trial?

A big factor is skepticism about the pharma industry. Presented with the statement “I believe clinical trials only benefit the pharmaceutical companies that run them,” 36% agreed, 36% disagreed, and 29% were neutral.

Said one respondent, “Clinical trials seem very scary and I feel usually they just look for the side effects and don’t really care how bad a person can potentially get.”

Significantly, sponsors and providers echoed these sentiments when asked why more people aren’t participating in trials today: They, too, cited a lack of awareness and understanding as well as a mistrust of pharma.

Patients, understandably, want to know what they’re getting themselves into. Will they feel unwell? What’s going into their bodies? How much time will it take? Again, sponsors and providers indicated that they are aware of the barriers.

Where this really gets interesting is comparing patient concerns to the actual experience of participants:

• 61% of participants say they didn’t feel sick or unwell.
• 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.

So, how do we leverage that data and that experience to help educate research-naïve patients? We’ll talk more about that in part two, but it’s clear we need to move out of our silos and start educating people about trials in the same way we educate about a newly marketed drug.

The Site Experience

Site staff generally agree that trials are designed with patients in mind (65%), and they would probably, or definitely, recommend participation to a friend or family member.

Their motivation appears largely altruistic. As one site staff member said, “Participating in clinical research is a core component to our dedication to patients. Ensuring that the best therapies are available to our patient population is important to them receiving the best care possible.” For example:

• 96% of site respondents cited a desire to contribute to the advancement of science.
• 95% cited the ability to bring new and/or better treatments to patients.
• 89% cited curiosity and/or interest in the new treatment being researched.
• 87% cited a desire to stay up to date on treatments in the specialty area.

They agree it was a valuable experience, one they’d repeat. 94% said they would “definitely” or “probably” participate in a clinical trial again, and 84% agreed with this statement: “The time I spent participating in this clinical trial was worthwhile.”

As one participant wrote, “The benefits for people and the improvements in medicine far outweigh the stress, incompetence, issues, faulty devices or changes that occur during a clinical trial. They are all different, but they all have issues in one way or another.”

Among the most pressing issues, from the site perspective:

• Protocol clarity: Only 38% strongly agree that the protocol was “clear & easy to follow.”
• Compensation: Only 27% strongly agree they were “compensated fairly & on time.”
• Consideration for staff: Only 15% strongly agree that “clinical trials are designed with sites/site staff in mind.”

One solution would be to solicit feedback from those closest to the trials. 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 aren’t seeking feedback. Rather, they are likely to be talking with key opinion leaders at large academic institutions when they should be collecting comprehensive feedback from all the different institutions and sites that might be participating in their clinical trial. As we move towards setting up de novo sites or bringing in more community centers, we need feedback on what is operationally feasible for them.

The CenterWatch responses align with Avoca’s findings, as seen in the ranking of the five lowest attributes:

Attributes with Lowest Sponsor Performance Ratings:
2023, 2021, 2019

Sponsors’ lowest-rated attributes	2023 mean rating	2021 mean rating	2019 mean rating
Protocol patient-friendliness	3.91	4.19	4.31
Appropriate number of protocol amendments required	3.88	4.05	4.15
Ongoing solicitation of feedback from sites and acting upon it*	3.87	—	—
Solicitation and inclusion of feedback from sites in protocol design	3.83	4.04	4.07
Flexibility to modify protocols	3.81	4.06	4.17

Note that two of the items relate to the solicitation and use of feedback, and the other three relate in some way to protocol complexity. So again, despite their passion for clinical research, site personnel report less-than-ideal experiences. If the site experience isn’t ideal, then the patient experience won’t be ideal either.

Next Steps

Both surveys point to the same conclusion: As sponsors and provider organizations, we need to improve communication and trust-building measures to research-naïve patients. We also need to listen to what sites and patients are telling us. By doing so, we improve the overall clinical trial experience, mitigate inefficiency, and accelerate research. How do we do this? That’s in part two.