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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
Summary
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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