Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives

As part of the Science of Patient Input (SPI) Initiative to develop a Framework for Patient Input in Medical Device Clinical Trials, the Medical Device Innovation Consortium (MDIC) conducted three surveys and one set of telephone interviews to compile information about patient engagement activities among device and diagnostic industry stakeholders, individuals identifying as patients, and a select group of medical device study investigators. Collectively, the information gleaned from these three surveys provides detailed perspectives on patient engagement during clinical research from key stakeholders in medical device clinical trials. This information will also be incorporated into the MDIC’s report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials.

In 2018, 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. For the third survey in 2020, we focused on investigators who received research funding from the Patient-Centered Outcomes Research Institute (PCORI) because PCORI requires investigators to engage patients and other stakeholders in their study.