MDIC’S Combined Survey Report: Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
Patient Introduction
Recognizing that the field of patient engagement in medical device clinical trials is evolving, MDIC conducted three surveys about patient engagement activities to better understand the current landscape. Survey participants included medical device and diagnostic industry stakeholders, patients, and investigators who received research funding from the Patient-Centered Outcomes Research Institute (PCORI). Patients may be interested in this report, which summarizes these three surveys and their findings, to better understand how the various stakeholders view patient engagement in device trials and where there are opportunities moving forward.
Summary
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 the industry on how to involve patients in the design of clinical trials. The third survey in 2020 focused on investigators who received research funding from the Patient-Centered Outcomes Research Institute (PCORI). Investigators receiving funding from PCORI are required to engage patients and other stakeholders in their studies. Key insights from the survey data highlight the lack of patient involvement by industry in study design and support the need for further work to enable medical device and diagnostic companies to gather meaningful input from patients into the design of clinical trials.
Jump directly to a specific note within the PDF Report:
CLINICAL
Overview, pg. 4
Background, pg. 5
1.1 – Patient Survey, pg. 7
1.2 – Industry Survey, pg. 7
1.3 – Clinical Investigator Survey, pg. 7
2.1 – Patient Survey, pg. 10
2.2. – Industry Survey, pg. 20
2.3.1 – Patient Engagement Frequency, pg. 29
2.3.2 – Patient Engagement Insights, pg. 29
2.3.3. – Methods for Engaging Patient Insights for Medical Device Clinical Trials, pg. 30
2.3.4 – Patient Engagement Challenges, pg. 31
2.3.5 – Patient Engagement Resource Gaps, pg. 32
2.3.6 – Patient Engagement Input Informing Changes to the Clinical Trial, pg. 32
2.3.7 – Patient Engagement Preparation of Partners, pg. 32
2.4 – Clinical Investigator Telephone Interview Results, pg. 33
3 – Conclusions, pg. 35