Listening to Sites and Patients, Part 2
Sponsors and provider organizations have the power to make trials more participant- and site- friendly and, at the same time, make trials more efficient. To do this, we must reimagine clinical research, from how we design and staff trials to how we compensate sites and patients.
In part one, we discussed how both the WCG Avoca 360° Assessment of the Clinical Trial Industry Survey and the WCG CenterWatch Global Site Relationship Benchmark Survey revealed the need for sponsors and provider organizations to improve their efforts to reach and educate research-naïve patients and site needs in clinical trials. These patients were wary of clinical trials, in stark contrast to the positive experience of actual participants. The surveys also revealed discontent among sites, especially in terms of feedback and protocol clarity.
Now, we’ll look at some solutions.
Raise Public Awareness
The surveys clearly revealed that clinical trials are an enigma to most patients. 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.
This suggests that we should educate and inform patients well before that steady recruitment pipeline begins. Participants and potential participants have many questions before and during the trial process. Here are some of the most important pieces of information people need as they become clinical trial participants [2021 CISCRP P&I Study]:
- Potential risks and benefits
- Purpose of trial
- Information about the drug being researched
- Types of medical procedures required
- How you will protect their confidentiality
- Whether they will learn the results
- Potential costs
- Length of participation
As discussed in part one, the Avoca survey found a general mistrust in pharma among patients who’ve never participated in a clinical trial. So how do we engage them? How do we foster trust in the trials, the research team, and the pharmaceutical companies?
For one thing, we take them seriously. We’ve all heard “I don’t want to be a Guinea pig” and “I don’t want the placebo” for decades. It’s easy to slip into the habit of responding, “Yeah, I know. You don’t want the placebo. Here’s what’s going to happen.” Instead, we should respond as though it’s the first time we’ve heard the question.
Misconceptions about clinical research and pharmaceutical companies, such as the belief that a cancer cure is being withheld, need to be addressed directly. You aren’t just educating one person: You are educating the friends and family members they talk to.
The best answer begins something like this: “That’s a great question. Let me help you understand this a little bit better.”
Equip the Site Staff to Answer Questions
No one will know the answers to all patient questions, but site personnel need to know it’s okay to say, “I don’t know that answer, but I do know who does,” or, “I don’t know the answer to that question, but here, let me look it up for you.”
Having a pocket protocol on your mobile could come in handy: The site staff can look up protocol questions or chat with a member of the study team. This shows the patient they can trust the information that you are providing, and that also builds trust in the clinical research team, the study team, and in research in general.
Each point of contact for a research participant becomes a decision point. Each time they meet with the study team, each time they meet with their investigator or physician, they’re going to ask themselves, “Based on the interaction I had today, do I want to continue on this clinical trial?” Potential participants who feel involved and informed during the experience are more likely to enroll in the clinical trial. Participants who feel involved and informed are more likely to remain involved and compliant.
This transparency needs to be consistent from beginning to end. During the trial, it’s important to communicate timely and transparent safety notifications to the participants. Keep patients apprised of the study progress — perhaps through newsletters or email updates. They also need to be informed about the results of a study once it closes — regardless of whether it gets published.
Patient/participant communication must work both ways, however.
Leveraging a Patient Advisory Board
A patient advisory board (PAB) provides first-hand expert insights on a disease — insights from the people who are living with that condition. These can inform protocol design and execution. Yet only 8% of protocols include a PAB.
We know that protocols developed with the insights of a patient advisory board had simpler protocols and more targeted designs, including:
- a 30% reduction in clinical endpoints,
- 20% fewer inclusion/exclusion criteria and
- a 50% reduction in the amount of data collected.
What’s Necessary to Answer the Question?
We know we simplify protocols by asking only what’s necessary to answer the question. But we don’t really understand what constitutes ”necessary” until we listen to the patients and solicit site feedback. By working with patient advisory boards from the outset, we learn what to ask. We’ll learn what the risks are before the site tells us that the inclusion criteria “completely eliminates all of our patients,” or “We don’t prescribe this drug or use this drug in our treatment regimens, so we’re not going to have any patients because it’s not standard of care for us.”
This in turn, can reduce amendments. Avoidable amendments — such as those that address design flaws, protocol inconsistencies, and impractical execution instructions — can be costly; eliminating even one substantial amendment can save millions and significantly reduce timelines.
That patient advisory board isn’t just helping you to design your protocol; it’s effectively helping you create ambassadors: Participants will share what they learned — and their enthusiasm for clinical trials — with others.
Listening to Sites
We must capture diverse site voices in the same way that we collect diverse patient voices. Being transparent in communication and documentation is essential to build trust and rapport. Ensure clear, timely, and effective communication with the site staff and the research participants. This includes providing training and resources, engaging with them regularly and answering their questions and concerns promptly. These best practices help reduce barriers to participation, improving the quality of data and ensuring a smooth and successful trial.
Just as you need to understand each patient in context, you need to understand the nuances, rules, and regulations of each site location, especially international sites.
Partner with organizations or experts who understand the intricacies of different regions and can help in overcoming any potential hurdles. Data collection practices also vary based on the region. What’s commonplace in the U.S., such as race and ethnicity data collection, can be challenging and sometimes penalized in other countries. It can help to partner with an organization that understands the nuances and regulations of the respective region.
Across the Trial
The future of successful clinical trials lies in our ability to actively listen and respond. Only then can we accurately identify barriers to enrollment, retention, and recruitment. As we think about ensuring that the patient and site voices are part of the clinical trial, we must think beyond the protocol design, to the risk assessment process throughout an entire clinical trial.
On-Demand Webinar Recording:
Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures
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