Patient Protocol Engagement Toolkit Enabled Delivery of Successful Patient-centric Advisory Board
Featured Solution: Patient Protocol Engagement Toolkit (PPET)
One member company leveraged the Patient Protocol Engagement Toolkit from TransCelerate as guidance for their first Patient Advisory Board (PAB) which was co-facilitated with an international patient organization.
The member company identified the need for early patient input in the clinical development program. The aim was to engage with the international patient organization to collect patient feedback on the phase 2 clinical trials that were planned for a rare disease. The member company wanted to understand patient perspective on the proposed protocol design, schedules, procedures and get input on how to make the study truly patient-centric.
The member company decided to collaborate with the international patient organization and to host a Patient Advisory Board (PAB).
As the phase 2 studies have global outreach, the member company needed to engage with patients from different geographies. The international patient organization, which already had a well-developed network of patients in various countries, was able to recommend participants from different countries.
The member company suggested leveraging the PPET as a set of guidance where the sponsor and international patient organization could choose areas of focus to help facilitate the PAB. The sponsor recommended questions from the PPET that were simple to help avoid language and cultural barriers. Also, they shared the slides and question sets in advance with the PAB moderators and the participants to allow for processing time as per the PPET guidance.
As a result, the level of engagement from patients was very high. The feedback from participants was that they appreciated that there were considerations built in for ease of access to information, clean simple instructions, and time was used wisely. This was possible because the question set and communication was clear and succinct (i.e. reducing barriers to input).
Furthermore, the output from the PAB confirmed that the proposed study design was acceptable from the patient’s point of view (not too invasive, allowed for reasonable participation, etc.). The PAB also provided some insight into areas where the schedule, timing, flexibility and ease of access could be improved to reduce the patient’s burden of participating in the trial. While drafting the first synopsis and protocol the member company team took on board the patient feedback. Based on feedback received in the PAB, the member company adjusted study visits and timing, asked for the study details to be shared back with the participants after the study, and adjusted the protocol so that the clinician could perform some of the tests twice to help ensure patients are given a second chance to remain in the study. These changes based on patient feedback should help improve patient recruitment, retention, and adherence within the trial.
