About this Research Topic
Traumatic brain injury (TBI) is a major and growing public health challenge, with more than 50 million people sustaining a TBI each year. Worldwide, it represents the leading cause of injury-related death and disability and a daunting burden to patients and families, as well as society and health care systems, which translates into an overall cost of $US400 billion annually.
Despite relentless efforts and dozens of clinical trials, to date no treatment has succeeded in improving outcomes after TBI. A major problem for drug development and medical practice is that clinical examination and current TBI classification schemas offer little insight into the complex pathobiological heterogeneity of patient phenotypes. Hence, prior clinical trials have not incorporated rational strategies to guide the selection of the most appropriate, and thereby effective, treatments for individual patients (Precision Medicine).
By providing objective measures of the underlying pathophysiology and an enhanced understanding of the injury characteristics and therapeutic targets, biomarkers have the potential to revolutionize scientific research and care in TBI, advancing targeted drug-development strategies and transforming patient management.
In this Research Topic, we will review the field of biomarkers for therapeutic decision-making in TBI, how these biomarkers could be most effectively used in drug development and in trial design, and how close we are to having such tools implemented in the real-world health care settings.
This Research Topic will:
• Examine biofluid proteins or expressed genes, reflecting damage or molecular pathways, that can be used to stratify disease, guide rationally designed mechanism-based therapies, and reflect target engagement.
• Illustrate high-throughput omics techniques capable of identifying new biomarkers and molecular target candidates to improve TBI classification and inform drug development.
• Address the emerging role of bioinformatics and artificial intelligence as innovative predictive computational approaches to analyze biomarkers and their relationships with therapeutic intervention.
• Discuss preclinical and clinical programs that integrate molecular diagnostics with therapeutics approaches, using molecular profiling to guide therapies, stratify trial participants, monitor/ predict response to therapy, or as surrogate endpoints.
• Provide perspectives on histological techniques, conventional and advanced neuroimaging, and multimodality physiologic monitoring as tools for TBI precision medicine.
• Outline regulatory pathways for approval of new biomarkers, emphasizing the need for innovative trial designs, high standards for data quality, and large-scale collaborative efforts.
This is not an exhaustive list and we will be happy to receive other relevant manuscripts.
Despite relentless efforts and dozens of clinical trials, to date no treatment has succeeded in improving outcomes after TBI. A major problem for drug development and medical practice is that clinical examination and current TBI classification schemas offer little insight into the complex pathobiological heterogeneity of patient phenotypes. Hence, prior clinical trials have not incorporated rational strategies to guide the selection of the most appropriate, and thereby effective, treatments for individual patients (Precision Medicine).
By providing objective measures of the underlying pathophysiology and an enhanced understanding of the injury characteristics and therapeutic targets, biomarkers have the potential to revolutionize scientific research and care in TBI, advancing targeted drug-development strategies and transforming patient management.
In this Research Topic, we will review the field of biomarkers for therapeutic decision-making in TBI, how these biomarkers could be most effectively used in drug development and in trial design, and how close we are to having such tools implemented in the real-world health care settings.
This Research Topic will:
• Examine biofluid proteins or expressed genes, reflecting damage or molecular pathways, that can be used to stratify disease, guide rationally designed mechanism-based therapies, and reflect target engagement.
• Illustrate high-throughput omics techniques capable of identifying new biomarkers and molecular target candidates to improve TBI classification and inform drug development.
• Address the emerging role of bioinformatics and artificial intelligence as innovative predictive computational approaches to analyze biomarkers and their relationships with therapeutic intervention.
• Discuss preclinical and clinical programs that integrate molecular diagnostics with therapeutics approaches, using molecular profiling to guide therapies, stratify trial participants, monitor/ predict response to therapy, or as surrogate endpoints.
• Provide perspectives on histological techniques, conventional and advanced neuroimaging, and multimodality physiologic monitoring as tools for TBI precision medicine.
• Outline regulatory pathways for approval of new biomarkers, emphasizing the need for innovative trial designs, high standards for data quality, and large-scale collaborative efforts.
This is not an exhaustive list and we will be happy to receive other relevant manuscripts.
Keywords: Traumatic Brain Injury, TBI, Biomarkers, Precision Medicine, RCTs, patient stratification, proteomics, epigenetics, omics
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