Patient Advisory Boards Essential to Mitigating Protocol Complexity, Experts Say
In this time of growing trial complexity, the use of patient advisory boards is critical to improving the patient and site trial experience — but just a small fraction of protocols currently use them, according to two WCG experts.
The trend of increasing protocol complexity is one of the most prominent challenges facing clinical research today and it shows no indication of stopping (CenterWatch Weekly, May 15). For this reason, gathering site and patient input on trial design is absolutely essential on the part of sponsors, both for sites conducting trials and patients taking part in them.
Patient advisory boards can play a huge part in alerting patients to trial opportunities, bolstering recruitment/retention numbers and making trials truly patient-centric. Despite this, data from the Tufts Center for the Study of Drug Development (CSDD) show that although there’s been a 37 percent rise in phase 3 endpoints since 2015, just eight percent of protocols overall utilize these advisory boards.
Speaking during the finale of WCG’s The Participant Playbook, a five-part webinar series on achieving patient-focused trials, WCG experts Sandy Smith, senior vice president of clinical solutions and strategic partnering, and Jamie Harper, vice president of site solutions and engagement, cited data that demonstrate the benefits of patient advisory boards in terms of cutting down complexity.
Those 8 percent of protocols that used patient advisory boards, according to Tufts CSDD, saw 30 percent fewer clinical endpoints, 20 percent fewer inclusion/exclusion criteria and a 50 percent reduction in the amount of data, all of which help significantly simplify trials.
“That’s a huge burden taken off of the sites and the participants who are informing those data points,” Harper said.
Likewise, Smith noted this reduction in burden translates to money saved and contended that patient advisory boards are uniquely suited to not only assess financial impact, but also to gauge the protocol burden on patients and equity in access and representation.
“Listen to what the patient wants in order to feel a sense of belonging to that trial,” Smith said, adding that sites and sponsors should assess the trial’s needs. “Are all of those visits required? Are all of those data points actually needed, or is it collecting a lot of information for the sake of having information but not necessarily leading to the endpoints for that trial?” Smith said.
A number of factors add to complexity and, consequently, trial burden. The use of technology, for instance, is a big contributor, Smith said. According to a 2022 Florence Healthcare survey, 42 percent of site respondents use more than six tech platforms for an average trial.
Technology can also make patients anxious, Smith observed, whether it’s from maintaining patient-reported outcome diaries, filling out forms on smart phones or using wearable devices for data collection.
Also give thought to the length of informed consent/reconsent forms, which are quite long today, in Smith’s experience. The same goes for inclusion and exclusion criteria, which many believe should be seriously reconsidered to expand trial access (CenterWatch Weekly, Aug. 15, 2022).
“We’re seeing very lengthy consents, and it does concern me to some degree. How many people are just flipping the pages to get to the signature line because they’re fatigued? Perhaps they really don’t understand it,” Smith said. “For some of the trials, [inclusion/exclusion criteria] are very narrow and only a certain subset of individuals will fit those criteria.”
According to a 2021 Center for Information and Study on Clinical Research Participation study cited by Harper, the four core reasons for participant dropout are:
- Poor communication with the trial site;
- The site’s location;
- Investigational drug side effects; and
- Cumbersome procedures during site visits.
Concluding The Participant Playbook webinar series, Smith urged sponsors to seek site and patient input as early as possible during the protocol design process and understand that building an understanding of participant motivation is critical to successful trial enrollment.
Access the entire webinar series here: https://bit.ly/3KlqJVi.
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