Enhancing involvement of people with multiple sclerosis in clinical trial design
Emma Gray, Anneesa Amjad, Jenny Robertson, Judy Beveridge, Susan C. Scott, Guy Peryer, Marie Braisher, Cheryl Pugh, Sara Peres, Ruth Ann Marrie, Maria Pia Sormani, Jeremy Chataway
Abstract
BACKGROUND: Although often overlooked, patient and public involvement (PPI) is vital when considering the design and delivery of complex and adaptive clinical trial designs for chronic health conditions such as multiple sclerosis (MS). METHODS: We conducted a rapid review to assess current status of PPI in the design and conduct of clinical trials in MS over the last 5 years. We provide a case study describing PPI in the development of a platform clinical trial in progressive MS. RESULTS: We identified only eight unique clinical trials that described PPI as part of articles or protocols; nearly, all were linked with funders who encourage or mandate PPI in health research. The OCTOPUS trial was co-designed with people affected by MS. They were central to every aspect from forming part of a governance group shaping the direction and strategy, to the working groups for treatment selection, trial design and delivery. They led the PPI strategy which enabled a more accessible, acceptable and inclusive design. CONCLUSION: Active, meaningful PPI in clinical trial design increases the quality and relevance of studies and the likelihood of impact for the patient community. We offer recommendations for enhancing PPI in future MS clinical trials.