Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

New Study Reveals How Electronic Health Records Can Benefit Clinical Trials

By Swansea University | May 16, 2018

The study entitled “Long term extension of a randomised controlled trial of probiotics using electronic health records” led by researchers in the Swansea University Medical School and the College of Human and Health Sciences, was published in Scientific Reports.

The findings demonstrate the potential of using anonymised routinely collected electronic health records, such as those linked in SAIL, for more complete trial results. Results showed that SAIL can help track trial participants, with long term monitoring of medical interventions and health outcomes, and new insights into population health.

Typically, RCTs are relatively short term, and due to costs and resources, have limited opportunity to be re-visited or extended which means the effects of treatments cannot be scrutinised beyond the duration of the study, typically 1-2 years.

With patients’ consent, data analysts can match patients to their records and access data quickly. As a result, the cost of follow-up using routine data is potentially relatively small and does not increase with the number of participants.

The original RCT investigated the impact of probiotics taken during pregnancy on childhood asthma and eczema in a group of children at 6 months and then 2 years of age.

Professor Sue Jordan of Swansea University’s College of Human and Health Science who led the study said: “In this study we reported on the feasibility and efficiency of electronic follow up, and compared it with traditional trial follow up. We gained new insights from outcomes electronically recorded 3 years after the end of the trial, and could then identify the differences between trial data and electronic data.”

The use of electronic databases in clinical trials has been hailed as one of the major benefits of a nationwide electronic health records system. However, few studies have demonstrated this benefit, or formally assessed the relationship between traditional trial data and electronic health records databases.”

Key research findings

 

  • Using SAIL, the retention of children from lower socio-economic groups was improved which helped reduce volunteer bias.

     

  • Results from the electronic follow up were more reliable due to reduced risk of bias, unreliability or inaccuracy in participants’ recall.

     

  • New insights were gained from the electronic five year follow up, particularly for asthma, which typically appears after 2 years of age

     

  • For the electronic follow up at five years, retention was still high and free of bias in socio-economic status

     

  • Any future extension of the trial is straightforward.

     

Follow up of trial participants on anonymised routine electronic health care databases such as SAIL offers great potential to maximise the economic efficiency of trials and allow access to a fuller range of health information.

SAIL Associate Professor Kerina Jones is the academic lead for data governance and public engagement. She said: “SAIL is a world-class, privacy-protecting data linkage system that securely brings together routinely-collected health data.

SAIL is part-funded by the Welsh Government, and makes person-based health data available for genuine research purposes only where there is a potential for benefit. Because SAIL removes the identities of participants to protect their privacy and holds only anonymised data, researchers carry out their work without knowing the identities of the individuals.”

Professor Jordan said: “The number of participants volunteering for RCTs is decreasing, particularly amongst the most economically disadvantaged. Trial data are vulnerable to misunderstandings of questionnaires or definitions of illness.”

Professor Michael Gravenor, who led the data analysis for the study said: “These results lead us to conclude that using electronic health records have benefits relating to the cost-effective, long term monitoring of complex interventions which could have a positive impact for future clinical trial design.”


Filed Under: Drug Discovery

 

Related Articles Read More >

Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE