Craft Trial Participant Questionnaires to Limit Burden, Increase Benefit
Sponsors are increasingly using questionnaires to gather data and feedback from trial participants on their experience with the investigational product and the trial in general as part of a push to enhance engagement. And while participants usually appreciate the opportunity to contribute, too-frequent surveys can wear on their patience and create additional work for site staff. The question that must be considered is “how do you create a balance between benefit and burden for both participants and staff?”
Sites need to start in the planning stage to review how much time and effort such requests for input demand of each side, paring down sponsors’ questionnaire requests when necessary and letting participants know what will be expected of them from the beginning of the trial.
“It’s not just patients that are being asked to do more as part of research. Sites have to balance their potential stressors at the same time as maintaining their focus on the patients,” said Tyler Bye, director of program strategy and product development for WCG’s Site Augmentation Solutions team. “At study initiation, it is imperative sites review the commitments a study places on the patient and the site and take steps to plan accordingly for the most limited resource: time.”
Some sites may develop and conduct their own surveys to monitor patient interactions with study staff and the facility itself, but generally, participants are seeing more sponsor/CRO-developed surveys done to support protocol execution, says Ken Getz, executive director of Tufts University’s Center for the Study of Drug Development (CSDD).
It’s certainly a good thing that sponsors and CROs are more frequently gathering input from trial participants and heeding the FDA’s call for more patient-focused drug development, Getz told CenterWatch Weekly. At the cost of some extra burden, some participant feedback can be used to enhance the trial experience, for instance, or be shared with participants’ treating physicians in appropriate circumstances.
“What we have seen time and time again is that more input and feedback from patients is generally better than not soliciting that input,” he said. But on the site side, it means their staff need to figure out how to coordinate collecting those data, often “scrambling behind the scenes,” in a sense, to ensure the sponsors and CROs get the information they’re surveying patients for.
For sites, addressing this increasing workload “begins with a lot of expectation-setting, some of that with the patient,” Getz said. From the point at which a participant is learning about the protocol, the trial experience and what will be required of them, lay out what will be expected in terms of survey completion. Ensuring that patients are aware of and prepared for a questionnaire at a revisit, for example, or a survey on their mobile device after each visit, will help site personnel. When this is done, the work “starts to feel like it’s more integrated and coordinated as part of a well-planned and executed experience,” he said.
Flexibility is also important. Questionnaires may be administered to patients using technology that provides a more hybrid approach for participants. Whenever possible, sites should consider what feedback-gathering approach is best for both participants and staff, he advised. When the technology is user-friendly and working properly, site staff may have more time to focus on in-person visits and other aspects of enhancing the site-participant relationship. On the other hand, it’s important to remember that a digital divide does exist for some participants and their families.
It’s important that sites and sponsors alike are mindful of participants’ needs and interests when designing questionnaires. According to Steve Smith, WCG’s president of patient advocacy, one common complaint is that the same questions are asked over and over while the feedback gathered isn’t shared with participants or anyone else. Questionnaires should be focused and well-designed, Smith said. Too often, using technology or automated systems to collect feedback makes it easier to add questions without putting much thought behind them.
“We tend to create these very cumbersome and lengthy questionnaires without really taking the time to isolate the questions that are most critical and identify those that are nice to have but not essential,” Getz noted. “There’s a huge opportunity when we’re surveying patients, as well as our professionals, to really try to streamline, shorten and focus the questionnaires we’re conducting.”
To some participants and advocacy groups, it may seem like sponsors and site staff aren’t paying attention to the answers when they ask redundant and seemingly inconsequential questions, Smith said. To avoid this perception, site staff should educate participants on the reasons behind the questions and the data collection methods employed, he recommended. Whenever possible, tell patients what’s being done with the information they’ve taken the time to share.
“Connecting the feedback from the survey to future interaction, showing patients that some of their input was applied, taken to heart and led to a specific enhancement or change to the participation experience — perhaps a convenience-enhancing step that was implemented while the study was underway — those are important parts of the partnering experience,” Getz said.
Mike Hu, a patient advocate and member of WCG’s patient advocacy advisory board who has had two children take part in trials, wants to see sites working with sponsors in advance to go over questionnaires and ensure they make sense, especially ones made specifically for a trial that may have been crafted by the sponsor’s team with less consideration and understanding of the clinical setting or relevance. And, like Getz and Smith, he believes it’s critical that site staff communicate the importance of questionnaires and why patients are being asked to take them.
While there’s certainly a limit to how many questionnaires should be administered in a trial due to the burden they add to patients, caregivers and sites, Hu said he views them as positive overall, especially for rare diseases that still require a greater understanding.
“To me, it shows the commitment and effort of the sponsor to maximize the understanding of the disease, particularly from a parental or family experience perspective,” he said. “For rare diseases, we generally know too little, and it would help the field if every patient’s family can contribute to the knowledge base.”