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Global Medical Sciences Group Looks At Benefits, Challenges And Risks Of Using RWD

 
• By Vibha Sharma

The non-profit Council for International Organizations of Medical Sciences (CIOMS) has issued draft recommendations on using real-world evidence for the approval, use and reimbursement of medicinal products.

Background image of computer screen showing electronic medical records application with computer lab
RWD can complement data generated from randomized control trials • Source: Alamy

The increasing importance of real-world data (RWD) in clinical development and regulatory decision-making has prompted the Council for International Organizations of Medical Sciences to issue a new consensus report on this topic.

Key Takeaways

  • Real-world evidence (RWE) is well accepted by drug regulators for satisfying post-approval safety monitoring requirements, but there is now increasing willingness for its use to demonstrate drug effectiveness.

The draft CIOMS report – published on 6 June for stakeholder consultation – aims to inform discussions about the use...

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