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Related Experiment Videos

The Internet and randomised controlled trials

M A Kelly1, J Oldham

  • 1Centre for Health Services Research, University of Leeds, UK. mikek@epid.leeds.ac.uk

International Journal of Medical Informatics
|March 20, 1998
PubMed
Summary
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New Internet Trials Service (ITS) methods enable larger sample sizes, shorter sampling periods, and lower unit costs for clinical trials. This approach uses the World Wide Web for global access, fast interaction, and automation, improving trial efficiency.

Area of Science:

  • Clinical Trials Methodology
  • Health Informatics
  • Internet-Based Interventions

Background:

  • Randomised Controlled Trials (RCTs) face constraints like large sample size requirements, long sampling periods, and high unit costs.
  • Multicentered, multinational trials or extended sampling durations are often necessary to achieve adequate sample sizes.
  • There is a need for innovative methods to facilitate larger sample sizes, reduce sampling times, and lower costs in clinical research.

Purpose of the Study:

  • To introduce and evaluate a prototype Internet Trials Service (ITS) for conducting international clinical trials.
  • To leverage the World Wide Web (WWW) for global access, rapid interaction, and automation in clinical trial management.
  • To address the limitations of traditional RCT implementation by exploring novel digital solutions.

Related Experiment Videos

Main Methods:

  • The Internet Trials Service (ITS) is hosted on a web server, providing HTML documents detailing the clinical trial protocol.
  • Registered centers use ITS to enter patients into the Growth Restriction Intervention Trial (GRIT).
  • Java applets are employed for local data collection, validation, and user interface, returning study numbers and randomization. Security measures include data anonymization and audit reports for authentication.

Main Results:

  • A prototype ITS was tested with the international Growth Restriction Intervention Trial (GRIT).
  • The ITS demonstrated the feasibility of using the WWW for global patient recruitment and data collection.
  • Java applets facilitated local data validation and a sophisticated user interface within web browsers.

Conclusions:

  • The Internet Trials Service offers a viable solution to overcome traditional constraints in implementing large-scale clinical trials.
  • The WWW and associated technologies like Java can significantly enhance the efficiency and accessibility of multicentered international research.
  • ITS provides a framework for more cost-effective, faster, and broader participation in clinical research through digital innovation.