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Increasing Rigor of Preclinical Research to Maximize Opportunities for Translation
Hannah L Radabaugh1, Adam R Ferguson1,2, Helen M Bramlett3
1Brain and Spinal Injury Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.
Abstract:
The use of animal models in pre-clinical research has significantly broadened our understanding of the pathologies that underlie traumatic brain injury (TBI)-induced damage and deficits. However, despite numerous pre-clinical studies reporting the identification of promising neurotherapeutics, translation of these therapies to clinical application has so far eluded the TBI research field. A concerted effort to address this lack of translatability is long overdue. Given the inherent heterogeneity of TBI and the replication crisis that continues to plague biomedical research, this is a complex task that will require a multifaceted approach centered around rigor and reproducibility. Here, we discuss the role of three primary focus areas for better aligning pre-clinical research with clinical TBI management. These focus areas are (1) reporting and standardization of protocols, (2) replication of prior knowledge including the confirmation of expected pharmacodynamics, and (3) the broad application of open science through inter-center collaboration and data sharing. We further discuss current efforts that are establishing the core framework needed for successfully addressing the translatability crisis of TBI.
Insights
Improving traumatic brain injury (TBI) treatments requires addressing the gap between animal studies and human application. Focusing on protocol standardization, knowledge replication, and open science can enhance TBI neurotherapeutics translation.
Area of Science:
- Neuroscience
- Translational Medicine
- Biomedical Research
Background:
- Animal models advance understanding of traumatic brain injury (TBI) pathology.
- Numerous pre-clinical neurotherapeutics for TBI have not translated to clinical success.
- The TBI field faces a significant translatability crisis.
Purpose of the Study:
- To propose a multifaceted approach to bridge the gap between pre-clinical TBI research and clinical application.
- To highlight key areas for improving the translation of TBI therapies.
- To address the challenges posed by TBI heterogeneity and the replication crisis.
Main Methods:
- Discussion of three primary focus areas: protocol standardization, knowledge replication, and open science.
- Analysis of current efforts in establishing a framework for TBI research translatability.
- Emphasis on rigor and reproducibility in pre-clinical studies.
Main Results:
- Identified three critical areas for improving TBI research translatability: standardized protocols, replication of findings, and open science practices.
- Highlighted the necessity of inter-center collaboration and data sharing.
- Discussed ongoing initiatives to build a foundational framework for successful TBI therapy translation.
Conclusions:
- A coordinated effort focusing on rigor, reproducibility, and open science is essential for TBI neurotherapeutics.
- Standardizing protocols, replicating prior knowledge, and fostering collaboration will improve clinical translation.
- Addressing the translatability crisis requires a paradigm shift in pre-clinical TBI research methodologies.
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