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Forced randomization: the what, why, and how.

Kerstine Carter1, Olga Kuznetsova2, Volodymyr Anisimov3

  • 1Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.

BMC Medical Research Methodology
|October 8, 2024
PubMed
Summary
This summary is machine-generated.

Forced randomization (FR) in clinical trials improves patient experience and efficiency by preventing drug supply issues. Careful planning and supply strategies ensure minimal risks and treatment imbalance in randomized controlled trials (RCTs).

Keywords:
Drug supply chain managementInteractive response technology (IRT)Multi-center clinical trialPoisson-gamma model

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Area of Science:

  • Clinical Trial Design
  • Pharmaceutical Research
  • Biostatistics

Background:

  • Clinical sites may encounter situations where an eligible participant cannot be randomized due to unavailable treatment at the site.
  • Interactive response technology (IRT) allows for 'forced randomization' (FR) to allocate participants to available treatment arms.
  • Industry consensus suggests FR is acceptable in confirmatory trials if instances are limited, but statistical properties require further understanding.

Purpose of the Study:

  • To explore the statistical properties and practical implications of forced randomization (FR) in randomized controlled trials (RCTs).
  • To evaluate the impact of different IRT configurations and drug supply strategies on trial operations when using FR.
  • To provide a framework for the development and evaluation of randomization designs incorporating FR.

Main Methods:

  • Described four IRT configurations with and without FR, illustrating with an example.
  • Conducted a database search (Cortellis) to determine the prevalence of FR in clinical practice.
  • Developed a template for evaluating FR designs and applied it to a hypothetical multi-center RCT under various recruitment and supply scenarios, using Julia code for simulations.

Main Results:

  • FR can eliminate patient refusals, improve logistics, drug management, cost-efficiency, and reduce recruitment time.
  • A Cortellis search revealed limited reported use of FR, typically documented in IRT specifications.
  • Simulations indicated low FR percentages in realistic settings; FR with backfilling and high re-supply minimized treatment imbalance and recruitment time, with drug overage mainly influenced by re-supply strategy.

Conclusions:

  • FR, when combined with appropriate drug supply strategies, offers significant improvements in patient/site experience, trial logistics, and efficiency.
  • FR effectively prevents refusals and unblinding, contributing to smoother trial conduct.
  • FR is a valuable feature for multi-center RCTs when properly planned and implemented.