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Translational medicine: science or wishful thinking?
1Clinical Pharmacology Mannheim, University of Heidelberg, Mannheim, Germany. martin.wehling@pharmtox.uni-heidelberg.de
Journal of Translational Medicine
|June 19, 2008
Summary
Translational medicine aims to improve patient outcomes but faces challenges in translating preclinical findings to clinical success. Developing robust methods and a new science, translational science, is crucial for bridging this gap.
Area of Science:
- Biomedical Research
- Drug Discovery and Development
- Clinical Translation
Background:
- Despite increased R&D investment, novel medicine output is declining.
- A significant gap exists between biomedical research input and therapeutic output.
- The transition from preclinical to clinical stages is a major bottleneck in drug development.
Discussion:
- Current preclinical models (animal, in vitro) inadequately predict human efficacy and safety.
- Improved translation requires scientifically robust methods for biomarker development and predictivity assessment.
- Advanced biostatistical methods and optimized early human study designs are essential.
Key Insights:
- The "translational medicine" goal is hampered by the poor predictive power of existing R&D models.
- Reliable prediction of drug efficacy and safety necessitates better methods for evaluating compounds in human-relevant contexts.
- The development of novel biomarkers and sophisticated study designs is critical for successful translation.
Outlook:
- A new scientific discipline, "translational science in medicine," is proposed to address these challenges.
- This new science will focus on developing and implementing advanced methodologies for effective translation.
- The ultimate aim is to accelerate the delivery of novel therapeutics to patients by improving the R&D process.
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