EMA Issues Guideline on RWE in Registry-Based Studies

The European Medicines Agency (EMA) has released new guidelines for using and generating RWE in registry-based studies. The guideline highlighted a commitment to avoiding bias resulting from non-randomized studies through responsible database usage. Likewise, the EMA guidelines emphasize the need for a clearly pre-defined study methodology from manufacturers. In addition, it focused on ensuring quality data.

According to an Aetion report on the Guideline’s draft guidelines shortly before release, “EMA recommends that manufacturers utilize the REQuEST tool developed by EUnetHTA to evaluate the suitability of the registry for the research question of interest. EMA also recommends that a manufacturer collaborate with registry holders to conduct feasibility analyses before initiating a registry-based study. Manufacturers should evaluate data availability and quality, potential biases, and data privacy when building a registry-based study protocol.”

Read more about the guidelines and find a link to the final document .

(Source: Aetion, November 12^th, 2021)