UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions.
MHRA exaplained that real-world data source in clinical trials “has the potential for increasing the speed and reducing the cost of development programs, which would see effective medications being approved more quickly, or even programs which were previously thought to be unfeasible becoming feasible, with the consequent benefit to public health”.
The guidance provides information on data quality standards to be considered for the trial data base. Moreover, it reports examples of real world data study types and a discussion of such aspects of these studies as endpoints derived from electronic health records and digital health technologies.
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Meditrial’s Catchtrial electronic Patient-Reported Outcomes (ePRO) app facilitates better interaction between the patient, investigator and Sponsor by analyzing the status of patient’s health directly received from patient.
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For more details, please see the guidance from the MHRA.
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