Development of a Risk-tailored Approach and Dashboard for Efficient Management and Monitoring of Investigator-Initiated Trials Journal Articles uri icon

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abstract

  • Abstract Background Most randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. A comprehensive approach identifying and continuously checking critical trial risks (e.g. insufficient recruitment, missing data) to allow the timely initiation of corrective action is, therefore, needed. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard. Methods We performed a systematic literature review to identify risk indicators and trial monitoring approaches followed by a contextual analysis involving local, national and international stakeholders. Based on this work we developed a risk-tailored management approach with integrated monitoring for RCTs and including a visualizing trial dashboard. We piloted the approach and refined it in an iterative process based on feedback from stakeholders and performed formal user testing with investigators and staff of two clinical trials. Results The developed risk assessment comprises four domains (patient safety and rights, overall trial management, intervention management, trial data). An accompanying manual provides rationales and detailed instructions for the risk assessment. We programmed two trial dashboards tailored to one medical and one surgical RCT to manage identified trial risks based on daily exports of accumulating trial data. We made the code for a generic dashboard available on GitHub that can be adapted to individual trials. Conclusions The presented trial management approach with integrated monitoring enables user-friendly, continuous checking of critical elements of trial conduct to support trial teams in the academic setting.

authors

  • Klatte, Katharina
  • Subramaniam, Suvitha
  • Benkert, Pascal
  • Schulz, Alexandra
  • Ehrlich, Klaus
  • Rösler, Astrid
  • Deschodt, Mieke
  • Fabbro, Thomas
  • Pauli-Magnus, Christiane
  • Briel, Matthias

publication date

  • November 18, 2022