FDA Draft Guidance for Adaptive Designs for Medical Device Clinical Studies

The U.S. Food and Drug Administration (FDA) issued a draft guidance today for Adaptive Designs for Medical Device Clinical Studies.  The document provides guidance on how to plan and implement adaptive designs for clinical studies that allow for prospectively planned modifications based on accumulating study data without undermining the integrity and validity of a trial.

Read the full draft guidance here

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, on Monday, 20 April 2015, from 1:00 p.m. – 2:00 p.m. EDT.

The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for regulated clinical investigations.  A copy of the guidance may be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Access the Webinar on Monday, 20 April 2015, from 1:00pm - 2:00pm using the following link: https://collaboration.fda.gov/guidancewebinars/