1. Pink Sheet

EMA Consults On Using RWD In Non-Interventional Studies

 
• By Vibha Sharma

The European Medicines Agency has developed draft recommendations on the key methodological factors to consider when conducting and assessing observational studies with real-world data for regulatory decision-making throughout a medicine's lifecycle.

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A critical aspect when assessing the suitability of RWD for regulatory use is data quality • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on the critical methodological aspects that sponsors should consider when they conduct non-interventional studies with real-world data (RWD) to generate evidence for regulatory purposes.

The EMA’s proposed approach is discussed in a draft reflection paper on which comments are being accepted until 31 August. The paper is focused on non-interventional or observational studies....

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