The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.
Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.
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The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input.
Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on how to increase and utilize patient input to improve clinical trials in the medtech space.
In the report, MDIC cited that FDA guidance, which defined patient engagement as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” Effective engagement, according to the administration, could result in faster recruitment, enrollment and completion for studies, greater participant commitment and less follow-up loss, greater compliance, fewer protocol revisions, streamlined data collection and more relevant data on important patient outcomes.
Patient input, according to MDIC, …