UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials.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.

Meditrial provides digital solution for electronic data capture and other digital solutions to empower your clinical trials:


To manage and control your study, Meditrial’s innovative team brought you cloud-based complete data management system Catchtrial. All in one CRF, Data Validator, Report Builder, Core Lab images and Safety Adjudicator to build your global trials.

Catchtrial is ready to support worldwide medical research by capturing clinical trial data and images with instant, advance and on-the fly translation cloud-based platform for every stakeholder associated with your study. Catchtrial is free for COVID-19 studies.


Meditirial’s Catchtrial ePRO is compliant, secure and intuitive solution to track complete patient data. It includes user-friendly Forms builder interface with easy data saving options. Catchtrial ePro is fully integrated with eDiary for automated daily, weekly and monthly patient data capture and with EDC for a real-time desktop access of the patient-reported data.

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.

Find out more about our digital solutions!

For more details, please see the guidance from the MHRA.

Contact Meditrial for immediate assistance in Europe or the US.