The value of patient input into protocol design increases in importance as protocols become more complex and study subjects more scarce. Absent patient input, protocols can be scientifically elegant but not practically feasible, especially in today’s highly competitive environment where multiple studies often compete for the same patient base.
The question then shifts from ‘should we’ elicit patient input, to ‘what types of patient insights add value’? I believe there are two distinct types, both having strengths and weaknesses. The first type is having patient KOLs participate in advisory board meetings. Patient KOLs input can be very helpful to provide a patient’s insights, ensuring better study participation. However, patient KOLs can become enamored with their roles as KOLs and, even subconsciously, shift allegiance from providing the voice of typical patients to being collaborative team members on numerous advisory boards.
The second type of patient input is via anonymous input from former study subjects who participated in your earlier clinical trials. Anonymous input from former study subjects provides practical, often tactical input into protocol design (and patient recruitment and enrollment initiatives). Challenges with this type of patient input are 1) the guidance is often more tactical than strategic and 2) the input is through a third party, diminishing its direct impact on decision-making.
Despite the limitations, patient insights into protocol design are likely to become standard practice. Watch this space during the next few years.
Ross H. Weaver, PharmD, MBA