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Learning from OCTET - exploring the acceptability of clinical trials management methods

Catherine Arundel1, Judith Gellatly2

  • 1Department of Health Sciences, University of York, York, UK. catherine.arundel@york.ac.uk.

Trials
|July 15, 2018
PubMed
Abstract

Insights

Successful clinical trial management relies on organization, open communication, and positivity. Clear processes and resources are essential for effective monitoring and control in research trials.

Area of Science:

  • Clinical research management
  • Trial operations
  • Health Technology Assessment

Background:

  • Research trials require effective management for timely recruitment and quality data collection.
  • Existing guidance for randomized controlled trials is often not comprehensive.
  • Lessons learned during trial conduct are infrequently shared.

Purpose of the Study:

  • To evaluate the acceptability of clinical trial management methods.
  • Focus on study execution and monitoring within the OCTET trial.
  • Assess trial management practices in a Health Technology Assessment Programme-funded study.

Main Methods:

  • Qualitative methods including workshops, questionnaires, and semi-structured interviews.
  • Thematic analysis of data collected from the OCTET Trial research team.
  • Exploration of trial management acceptability with 20 participants.

Main Results:

  • Six key themes emerged: support, communication, processes, resources, training, and ethos.
  • Clear communication, accessible trial managers, and enthusiasm were vital for trial success.
  • Adequate resources and training materials, alongside suggestions for process improvements (checklists, flowcharts), were identified as crucial.

Conclusions:

  • Organizational, open, and positive approaches are key to successful trial execution.
  • Well-defined processes and resources are critical for trial monitoring and control.
  • Findings offer insights applicable to the successful conduct of all research trials.
Keywords:
Project managementQualitativeRandomised controlled trialTrial management

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