Successfully Measured Participant Satisfaction in a Phase I Trial
Featured Solution: Study Participant Feedback Questionnaire (SPFQ)
“Within our member company, we had an objective to advance patient-centricity in our trials, but nothing was readily at hand to use within current trials. Our clinical operations office pivoted toward TransCelerate’s Study Participant Feedback Questionnaire (SPFQ) because the solution gave us a strong starting point; we did not have to “reinvent the wheel” to develop our own modified, paper-based survey. For two small phase-one studies in Europe, the study teams were highly receptive to adapting the SPFQ to assess participant satisfaction at the end of the study. We capped our version of the SPFQ to 10 questions and added a free text component so that participants could share recommendations for improvement areas.
Participation in the survey was anonymous and completely voluntary. Participants consented to participate in the survey after all study procedures were completed.
The ethics committees (ECs) approved our design of the SPFQ for each study. They supported this innovative approach to gathering data to improve future research for participants. Out of a total of 12 participants across both trials, 10 participants responded to the survey.
When asked about various study details and logistics, the participants’ responses showed high satisfaction levels. On rating satisfaction with different procedures during the study, most participants responded with four to five stars on a rating from one (low) to five (high). The vast majority of respondents indicated that their overall study experience was positive.
For our company, the positive SPFQ results were encouraging. We believed our site was operating well with participants and that we had authored a well-designed protocol for participants. The results from using the SPFQ confirmed that our studies are proceeding smoothly for participants. Although this was a small sample size, it provides a baseline measurement as we look to use the SPFQ in larger phase-two studies. At first, the site had expressed reservations about the survey implementation, but now they are more receptive to our approach. Some free text questions elicited minor feedback about some site equipment issues (e.g., chairs, beds, etc.). The site took the feedback as an opportunity to address the equipment issues for future studies.
Given this pilot’s success, we plan to roll out our version of the SPFQ to a global phase-two study whereby more than 200 patients will be surveyed.”
[Sponsor Company]
