When it comes to clinical trials, sponsor and provider organizations understand that sites are motivated by the science and the patients, and they recognize sites are under a tremendous strain. But recognition isn’t enough. Sites — and patients — need a voice.
That was one of the key takeaways from the 2023 Avoca State of the Industry Survey. It explored the disconnect between what research-naïve participants and investigators want and the ways in which sponsors currently conduct research.
This annual survey typically polls sponsors and providers. This year, it took a different approach, looking across all clinical trial stakeholders to identify opportunities for improvement.
It found them.
Complexity is an Obstacle
Sponsors and providers are aware of the increasing burden sites face, especially from protocol complexity and shrinking resources. Other stressors sponsors and providers acknowledge include:
- Overzealous protocols and unclear information
- Bureaucratic start-up processes and tight budgets with little support from the sponsor
- Overly complicated and constantly amended protocols
- Limited access to patient population and being unable to find the patient who meet the criteria
- Inadequate time to conduct complex trials
These burdens have a direct impact on the types of trials some sites will take on. As one sponsor wrote, “Even if the PI has a great interest in participating, some of those who coordinate may prefer a less complex trial … because of the burden placed on them.”
The sponsors and providers may understand the problem, but as far as sites are concerned, the challenges aren’t being addressed.
Is Anyone Listening?
The survey findings suggests that neither the site nor patient experience appear to be top of mind when it comes to trial design:
- Only 38% of the sponsors and providers surveyed strongly agreed that clinical trials conducted by their companies are designed with participants in mind
- Only 15% of site respondents strongly agreed that clinical trials are designed with sites/site staff in mind
- Only 29% of site respondents strongly agreed clinical trials are designed with patients/volunteers in mind
Sites want to be part of clinical research, but they need sponsors and CROs to consider their perspective. They want to be asked for their feedback, and they want sponsors to act on it. Some of the respondents were quite adamant in open-ended survey questions. For example: “ASK SITES FOR INPUT ON YOUR PROTOCOL. You are NOT an expert at boots-on-the-ground enrollment. Ask someone who is.”
Complying With Protocol: Conflicting Perspectives
Do these burdens lead to protocol deviations? Sites and sponsors/providers again have very different perspectives.
Only 21% of the sponsors/providers surveyed said that sites strictly follow all the instructions with no or little deviation, while 71% said sites mostly follow all the instructions, and 8% said they follow only some of the instructions. In contrast, 80% of sites said they strictly followed protocol during their most recent trial.
Sponsors/providers may have some doubts about how closely sites adhere to protocols, but 69% agreed with the statement “Healthcare professionals working on clinical trials that my company conducts carefully monitor the well-being of participants,” and only 3% strongly disagreed.
An Opportunity for Improvement: Listen
The survey highlights a disconnect between sponsors/providers and sites and gives voice to deep-seated site frustrations. Bringing this into the open gives us the opportunity to revisit how trials are designed, staffed, and compensated. The first step is to listen to what sites are saying –or what they would say, given the opportunity.
Perhaps the simplest thing sponsors and CROs can do is check in regularly with their sites and solicit feedback.
Such engagement needs to begin early, allowing sites to have a say in the protocol design. Their insights can help sponsors and CROs to promptly identify and address protocol design issues. As the trial progresses, listening to sponsor feedback will allow sponsors to identify and mitigate risks in real time.
This level of engagement and collaboration is no longer a “nice to have.” It’s not just the right thing to do. Increasingly, it’s a clinical and regulatory necessity.
For example, ICH E8(R1)’s “quality by design” focus calls for a comprehensive, stakeholder-inclusive approach to clinical trial design. Historically, sponsors have handled protocol design and risk assessment in a silo. Now regulators expect sponsors to engage stakeholders in protocol design and take operational feasibility into consideration.
It’s time to listen.
Download the full 2023 Avoca State of the Industry Report for more findings with a 360-degree view across clinical research stakeholders. For more than 20 years, WCG Avoca has surveyed industry executives to gain an understanding of key trends affecting outsourced clinical development. This year’s research expanded outreach to look across all clinical research stakeholders — sponsors, providers, sites, and patients — to identify opportunities to improve the patient and site experience.
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