Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data.

Background: Utilizing a participation burden algorithm developed in a previous study, Tufts CSDD, in collaboration with ZS, led a workshop among 8 pharmaceutical companies to validate the methodology of benchmarking the participation burden of a set of retrospective protocols and comparing these data to a prospective protocol design.

Methods: Eight participating companies collected data for 66 retrospective protocols and participation burden scores were calculated for each. Data from one prospective protocol was provided and prospective burden scores were compared to mean retrospective protocol burden for each company.