Project: Patient Participation in Clinical Trials

This project focused on helping medical device sponsors facilitate patient input and maximize patient participation in clinical trials by incorporating patient insights into development of inclusion/exclusion criteria, timing of study visits, frequency of tests and procedures, and methods for data collection. By incorporating patient perspectives within trial designs, clinical trials could see increased enrollment, compliance, and retention.

Full Summary

MDIC’s Patient Participation in Clinical Trials project comprises three major activities and resulting deliverables.

The first is a Literature Review, conducted throughout 2019 and 2020. The goal of this effort was to evaluate existing resources and materials in the public domain that could be relevant to medical device development and assist sponsors in advancing efforts to incorporate patient input in clinical trials. This review encompassed available materials in the device world, as well as relevant resources from the drug development arena. The resulting publication (which includes a short summary and active links) is up to date as of the end of 2020.

The second activity involved the conduct of three separate surveys among patients, device sponsors, and clinical investigators to understand the extent of knowledge about and implementation of patient input in medical device clinical trials from the perspective of three main stakeholder groups. Results from the three surveys and analysis of those results are incorporated in a Survey Report and a companion video. Key findings from the three surveys indicated a significant opportunity to expand awareness among device and diagnostic companies of the benefits and importance of patient input and leverage investigator experience with this type of work. Given the perceived barriers highlighted in the industry survey, there is a need to produce resources for device companies about how to go about gathering and employing patient input in trials.

The third activity resulted in the release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report. This report focuses on devices that must undergo clinical testing through trials to provide safety and effectiveness data for regulatory review and decision-making. For such devices, sponsor companies (both in the United States and globally) are increasingly seeking to include patient perspectives in the design and assessment of new medical technologies. Sponsors and regulators increasingly recognize the importance of leveraging patient insights in the conduct of device clinical trials, both in selecting outcomes that matter to patients and designing trial protocols that patients will join and can complete. This report identifies and describes in detail several key distinctions between device trials and drug trials that present unique opportunities, challenges, and resource needs for medical device sponsors seeking to engage patient insights, including: (1) Level of Invasiveness, (2) Outcomes Assessment, (3) Trial Enrollment, and (4) Trial Design. The report details and addresses the priority patient engagement objectives and opportunities associated with each of these four areas. Overall, this report provides a concise set of considerations for medical device developers to evaluate as they pursue patient engagement in their clinical trials and product development activities. Recognizing that this work is complex and understanding that no single compilation of information can provide everything a sponsor would need, the resources presented within this report are offered as a foundation from which sponsors can advance their efforts to generate and incorporate patient input into the design and conduct of medical device clinical trials.

Articles in

Patient Participation in Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations...

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report

This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.”  By...