MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report
Patient Introduction
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 encouraging sponsors to take the time and make the effort to build relationships with patient groups and individual patients that are based on a shared commitment to the effort, clear expectations, regular communications, and common terminology, this report offers a practical resource to improve the patient-centricity of medical device trials. Patients may be interested in reviewing this report to better understand the steps and approaches that are recommended for sponsors.
Summary
There are key distinctions between device trials and drug trials that present unique opportunities, challenges, and resource needs for engaging patient insights in the device field. In developing this report, MDIC evaluated a series of device trial characteristics (level of invasiveness; outcomes assessment; trial enrollment; and trial design) and prioritized them based upon their relevance for patient engagement. Drawing on existing resources and information identified through a comprehensive literature review and a series of surveys within the device ecosystem, the report provides information, resources, and best practice recommendations that can be used by device sponsors to assist their efforts to gather patient insights for clinical development programs.
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SPI GUIDING PRINCIPLES
DISCOVERY AND IDEATION
CLINICAL
Executive Summary pg. 7
1 Background and Objectives pg. 9
2 MDIC Framework Initiative pg. 11
3.1 Literature Review pg. 12
3.2 Surveys pg. 13
4 Unique Device Trial Aspects pg. 14
5.1 Invasive Procedures pg. 16
5.2 Reversibility pg. 16
5.3 Reporting of Side Effects and Symptoms pg. 16
5.4 Placebo/Sham Procedure pg. 17
6.1 Defining Objectives for Eliciting Patient Input pg. 18
6.1.2 Reflecting Patient Preferences pg. 21
6.1.3 Selecting Device Trial Endpoints that Matter pg. 22
6.1.4 Addressing Barriers to Device Trial and Retention pg. 24
6.1.4.1 Restrictive Eligibility Criteria pg. 25
6.1.4.2 Complex Informed Consent Procedures pg. 25
6.1.4.3 Burdensome protocols pg. 25
6.2.1 Securing Internal Support pg. 28
6.2.4 Engaging Legal and Compliance pg. 29
6.2.5 Engagement Planning pg. 29
6.3 Tactics pg. 32
6.3.1 Identifying Representative Patients pg. 32
6.3.4 Evaluating Multiple Types of Activities pg. 41
6.3.6 Compensation (Fair Market Value [FMV]) pg. 42
6.3.8 Engaging Patients in Interpretation/Dissemination of Findings pg. 43
6.3.9 Implementing Patient Input pg. 43
7 Opportunities for Future Work pg. 44