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Updated: Feb 20, 2026

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Methods for randomized, blinded, controlled evaluation of putative disease interventions in multilaboratory,

Jessica Lamb1, Karisma Nagarkatti2, Marcio A Diniz3,4

  • 1Department of Physiology and Neuroscience of the Zilkha Neurogenetic Institute of the Keck School of Medicine, Los Angeles, CA, USA. lambj@usc.edu.

Lab Animal
|February 18, 2026
PubMed

Insights

Implementing enhanced rigor in preclinical studies, like randomization and blinded outcomes, can improve the reliability of scientific research. This approach, demonstrated in stroke models, offers a practical solution to the reproducibility crisis.

Area of Science:

  • Neuroscience
  • Translational Medicine
  • Research Methodology

Background:

  • The scientific community faces a reproducibility crisis, impacting public trust.
  • Failures in large clinical trials often stem from inadequate preclinical study rigor.
  • Preclinical assessments frequently lack essential elements like randomization, blinding, and adequate sample sizes.

Purpose of the Study:

  • To demonstrate the feasibility and practicality of enhanced rigor in preclinical assessments.
  • To establish a framework for improving the reliability of early-stage disease intervention research.
  • To showcase the application of rigorous methods using acute ischemic stroke models.

Main Methods:

  • A six-laboratory network was established to implement rigorous study elements.
  • The study enrolled 2,615 rodents across 5 different acute ischemic stroke models.
  • A multistage, multiarm statistical design with interim analyses was employed, alongside centralized intervention packaging, randomization, data quality assessment, and archiving.

Main Results:

  • Rigorous study elements were successfully implemented across multiple laboratories and models.
  • Centralized packaging, randomization, and data quality control measures were effective.
  • Blinded analyses of extensive behavioral (9,274 tasks) and imaging (3,652 MRI) data were conducted.

Conclusions:

  • Enhanced rigor in preclinical assessments is feasible and practical.
  • The developed methods and protocols can be adapted for preclinical research in other disease areas.
  • This approach offers a potential solution to improve the reliability of scientific findings and rebuild public trust.

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