UK: MHRA supports generating RWE in clinical trials through digital solutions
UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials.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.
Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
