April 1, 2019, Medical Device Innovation Consortium (MDIC)

MDIC surveyed 53 device and diagnostic industry stakeholders and separately surveyed 123 individuals identifying as patients. The goal of the complementary surveys was to inform future work to develop guidelines for industry on how to involve patients in the design of clinical trials. 

Within our survey response populations, we discovered: 

• Over 50% of industry respondents involved in protocol development never gained patient input to protocol development. A further 28% gained input less than 25% of the time. 
• Figures were even greater for industry gaining patient input to operational study design after protocol finalization with over 80% involving patients never or less than 25% of the time. 
• There were some disconnects in the perspective of industry vs patients with regards to the reasons patients might enroll in a clinical trial, particularly around the importance of doctor recommendation. 

The lack of patient involvement by industry in study design, contrasted with some of the differences in perspective that this survey uncovered, supports the need for further work to enable medical device clinical trials.