Last fall HealthiVibe, a company that gathers patient insights to help improve clinical trials, held a meeting to discuss trial participant experience surveys. Attendees from pharma, sites, and industry groups gathered to discuss how they were using these types of surveys and ways to support their implementation.
HealthiVibe organized the meeting to help stakeholders learn from each other. “We were able to get together to discuss the nuts and bolts of survey implementation and what we have learned so far,” says Abbe Steel, founder and CEO of HealthiVibe. “One of the main topics of discussion was global deployment across organizations. We discussed how we are getting buy-in at all levels, how we are leveraging trial participant feedback to change the culture, and the role of the different stakeholders.”
Elizabeth Manning, Patient Engagement Manager at UCB Biosciences, Inc. was one of the attendees. One of Manning’s responsibilities is creating an overall strategy of how to best engage patients throughout the clinical development continuum. She notes the importance of gathering patient insights before and during a clinical trial, and not just getting feedback after studies are complete.
“Clinical study participant insights have the potential to impact decision making within our development programs,” says Manning. “This is far more efficient and valuable than coming up with development programs and then soliciting feedback from patients. Having those patient conversations earlier allows us to get feedback at a time when their insights can truly impact the company’s decisions.”
Manning notes that when companies work together on patient questionnaires, they create a baseline of understanding around what it is like for a patient to participate in a study. This allows companies to look at a broader set of data to discover where the clinical experience can be enhanced. Those insights will enable pharma to design studies in which patients will be able to better maintain their participation.
Patient Centricity Relies On Patient Input
Thérèse Johnsen, Associate Dir. Patient Engagement Management, Novartis Pharmaceuticals Corporation, also attended the meeting. Johnsen agrees that feedback is critical to understanding the patient experience.
“We must engage with patients to better understand their needs,” she says. “We can use their information to improve the study in which the patient is involved, but even more importantly, we can use those patient insights to design more effective studies which can help shape our development programs. This is one of the best ways we have for patients to tell us what they most need. Patients are keen to provide feedback on what we can do to improve their trial experience.”
Of course, asking the right questions and having the right discussions is critical. Manning notes it’s not the patient’s job to tell sponsors what they should already know. Pharma must have the right conversations with patients in order to hear their stories.
“Even after we have their feedback, we need to take those patient observations and interpret them appropriately,” she states. “For example, you can’t just ask a patient how many finger pricks is too many. That would be a difficult question for anyone to answer. What we want to do is get patients talking about their experience, so we can understand their feelings about actions such as finger pricks. Their insights will then allow us to answer that specific question.”
Johnsen agrees that asking the right questions is an essential part of the process. Ask a question the wrong way, and you get a data point. Ask it the right way, and you get feedback that will allow you to evaluate the patient experience more effectively.
Design The Right Questions
Asking the right questions can be a challenge. Many companies will select survey questions simply by consulting with colleagues in clinical operations. This approach can be shortsighted. Manning believes coming up with the right questions means engaging your experts in patient recruitment, market research, and data analytics. She also recommends involving psychometricians. Involving these team members will ensure questions are actionable and specific enough to clearly understand what patients are trying to relay.
Johnsen adds that involving experts from health economics and outcomes research (HEOR) is even more important if the questions are multiple choice rather than open-ended. “Involving HEOR experts ensures we are asking the right questions,” she adds.
When question design comes from internal experts and outside sources, it’s advisable to have patients evaluate them before soliciting feedback. Share the questions with patients to see if they understand the purpose of the question. Verify that their understanding matches the question’s intent. This will also allow researchers to have more confidence in the data that is gathered.
“This is why we conducted a survey development study prior to finalizing the survey,” notes Steel. “We gathered patient feedback and used the language from that feedback to develop the survey questions, ensuring they were understandable and in line with patient needs.”
Where Do We Go From Here?
As patient centricity gains traction in pharma, trial participant feedback will become increasingly important. Will patient surveys soon become standard operating procedure for improving trials for participants? Johnsen thinks so.
“At the conferences I attend, I hear more and more discussions about surveys,” she says. “The patients who are accepted into a trial are obviously the ones who directly match enrollment criteria. Their opinions are critically important. They are the patients you hope to attract, so they are ideal for providing feedback. Study groups get larger as we move through the trial process. Having the direct input of patients who participated in the Phase 2 trial can help clear up any issues that could make it difficult to recruit the Phase 3 study.”
Steel believes the value of benchmarking (using common questions to allow companies to measure progress and performance alongside others in the industry) was another takeaway from the meeting. “It was something we all seemed to agree on,” she says. “Our hope is that sponsors can get back together and share information and benchmarking value on the questions we can all consistently ask. That is information that can benefit everyone in the industry. We want this effort to be tangible and sincere, and we want the feedback to really drive decisions within companies.”