Devices

New MDIC Framework on Device Trials

The Medical Device Innovation Consortium (MDIC), of which FDA is a member, has released a new framework that outlines a systematic approach for patient-focused clinical trial designs. The group says the framework, “Using Patient Preference Information in the Design of Clinical Trials,” was developed to help inform researchers interested in conducting rigorous patient preference studies for medical device design, development, evaluation, and regulatory submissions.

MDIC says it encourages clinical trial sponsors to incorporate patient perspectives into the total product life cycle, from research and development, to clinical trial design, and regulatory decision-making. The approaches in the framework aim to:

Identify what matters most to patients
Measure patient input through proven qualitative and quantitative methodologies
Engage in advanced planning and communications with FDA
Include patients in trial design, recruitment, and outcomes

“One of the methods reviewed by the framework includes using a Bayesian Decision Analysis (BDA) model, which can help adjust statistical modeling considerations that can impact the study’s optimal sample size and measurements for achieving the study’s goals,” MDIC says. “Although BDA was developed decades ago, it was adapted to the patient-centered framework by Massachusetts Institute of Technology (MIT) professor Andrew Lo, who was involved in several case studies featured in the framework.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome