MDIC External Evidence Methods (EEM) initiatives will kick start 2019 with its Executive & Fellows In-person Meeting on April 2, 2019 at MDIC headquarters in Rosslyn.
MDIC EEM initiates aim to establish a more predictable pathway for use of external evidence methods, such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods for evidence fusion from data external to a clinical trial. External trial data includes but is not limited to real-world data (RWD), real-world evidence (RWE), engineering modeling and simulation, similar device clinical trial data, to support regulatory medical device decisions and other stakeholder decisions.
In the executives and fellows meeting on April 2nd, subject matter experts from FDA, medical device industry and non-profit organizations will discuss the existing statistical methods and identify the gaps for use of external data. The breakout sessions in the meeting will address different buckets of data viz. Historical Clinical study data (US/OUS), Registry Data, Modelling and Simulation as well as Admin Data (EHR, Claims etc.). Each session will focus on characterizing data type (data quality; access; relevance, cataloging existing statistical methods that can be utilized (Frequentist/Bayesian), describing limitations of existing methods/data type, identify gaps (areas where new methods need to develop), and identify examples for the use of external data as evidence.
If you would like to know more about EEM programs and collaborative opportunities, please contact Jithesh Veetil, PhD, MDIC Program Director at jveetil@mdic.org
