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Evaluating the Efficacy of Therapies in Patients With Coronavirus Disease 2019

Dan-Yu Lin1, Donglin Zeng1, Joseph J Eron1

  • 1University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|August 21, 2020
PubMed

Insights

This study introduces new methods for analyzing patient recovery trajectories in coronavirus disease 2019 (COVID-19) clinical trials. These advanced endpoints offer a more complete assessment of therapeutic benefits beyond single time points.

Area of Science:

  • Clinical Trials Methodology
  • Infectious Disease Epidemiology
  • Biostatistics

Background:

  • Numerous clinical trials are investigating treatments for coronavirus disease 2019 (COVID-19).
  • Current COVID-19 trial endpoints often focus on clinical status at specific time points or time to a single clinical event.

Purpose of the Study:

  • To propose novel endpoints for evaluating COVID-19 therapies that utilize the full clinical trajectory.
  • To demonstrate methods for combining evidence on treatment effects across multiple clinical events.

Main Methods:

  • Analysis of clinical status trajectories over the entire follow-up period.
  • Development of statistical methods to synthesize evidence from various clinical events.
  • Extensive simulation studies to compare proposed and existing endpoints.

Main Results:

  • The proposed trajectory-based endpoints provide a more comprehensive evaluation of treatment efficacy.
  • Methods for combining evidence across multiple events enhance the power to detect treatment benefits.
  • Simulation results indicate advantages of the new endpoints over traditional ones.

Conclusions:

  • Trajectory-based endpoints offer a fuller picture of patient clinical course in COVID-19 trials.
  • Combining evidence from multiple events strengthens the assessment of therapeutic benefits.
  • Guidelines are provided for establishing treatment benefits using these advanced endpoints.
Keywords:
clinical trialsendpointsseverity ratingstatistical powertotality of evidence

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