Real-World Evidence to Reinforce Clinical Trial Evidence in Health Technology Assessment: A Critical Review of Real-World Evidence Requirements from Seven Countries and Recommendations to Improve Acceptance.
Katia ThokagevistkCéline CoppoLaetitia ReyAmanda CarelliVeronica DíezSarah VaselenakLiana OliveiraAjay PatelEmilia SicariTeresa RamosSusanne SchachErika SchirghuberAlex SimpsonRemy ChoquetKatell Le LayPublished in: Journal of market access & health policy (2024)
All the countries reviewed face common challenges regarding the use of RWE. Our proposals address the need to facilitate collaboration and communication with industry and regulatory agencies and the need for specific guidelines describing RWE design and criteria of acceptance throughout the assessment and appraisal processes.