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International Clinical Trials

Ensuring Data Integrity with ePRO Methods



Ensuring data integrity during clinical trials is of the utmost importance. In the past few years, electronic patient-reported outcome (ePRO) approaches have been implemented to support these efforts, however, the pandemic has triggered a greater interest in wider deployment. The proliferation and acceptance of digital devices and wearables by regulators, clinicians, and patients has helped fuel this interest and highlighted the advantages of remote monitoring, helping bring clinical trials further into the modern age.

The 21st Century Cures Act and regulatory authorities, i.e., the MHRA and FDA, are embracing the need for more patient-centric drug development and wider access to ensure accurate data collection as trials become more decentralised. Decentralised clinical trials are defined as those executed through telemedicine and mobile/local healthcare providers using processes and technologies that differ from traditional clinical trial models.

For example, one of our partners is currently running 17 COVID-19 studies in ePRO. These studies are being conducted worldwide in more than 38 countries with sites of up to 400 and patient counts in the tens of thousands. Another partner is conducting 15 COVID-19 studies in ePRO. The adoption of these approaches certainly indicates that the market is confident in providing more patient-centric alternatives to the traditional trial model.

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About the Author

Sachin Bharadia is an Account Manager for the CRO PHASTAR. He has over 20 years’ experience in the pharmaceutical and CRO industry, alongside extensive experience of master data management, data lifecycle, and effective use of research data through biometrics and management and oversight of vendor relationships.

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