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In Silico Clinical Trials: Is It Possible?
Simon Arsène1, Yves Parès1, Eliott Tixier1
1Novadiscovery SA, Lyon, France.
Methods in Molecular Biology (Clifton, N.J.)
|September 13, 2023
Summary
In silico trials, a key part of model-informed drug development (MIDD), accelerate drug discovery. This work proposes integrated workflows and tools to overcome adoption barriers for more efficient clinical research.
Area of Science:
- Computational biology and pharmacology
- Drug development and regulatory science
Background:
- Modeling and simulation (M&S), including in silico trials, are crucial for accelerating drug development and reducing costs within model-informed drug development (MIDD).
- Diverse M&S approaches, from data-driven to physiologically-based models, present challenges in integration due to differing setups and data requirements.
- Regulatory bodies and developers are increasingly exploring in silico trials to refine, reduce, or replace traditional clinical trials.
Purpose of the Study:
- To address challenges in widespread in silico trial adoption by proposing integrated workflows and collaborative tools.
- To provide a coherent set of solutions for establishing best-practice workflows in in silico clinical trial development.
- To outline the characteristics of an in silico trial software platform using jinkō.ai as an example.
Main Methods:
- Development of a dedicated workflow for the in silico clinical trial lifecycle, incorporating principles from systems biology and quantitative systems pharmacology.
- Integration of specific steps for regulatory qualification within the proposed workflow.
- Description of key features for an in silico trial software platform implementation.
Main Results:
- A structured workflow for in silico clinical trial development and regulatory qualification is presented.
- The jinkō.ai platform is highlighted as an example of an end-to-end in silico clinical trial solution.
- The breakdown of silos between distinct modeling approaches is observed.
Conclusions:
- Integrated workflows and collaborative tools are essential for overcoming barriers to in silico trial adoption.
- In silico trials hold significant promise for refining, reducing, and potentially replacing clinical research, ushering in a new era of efficient drug development.
- Future applications include synthetic control strategies and digital twins, further enhancing drug development efficiency.
Keywords:
Clinical trialsDigital twinsDrug developmentDrug regulationHealth technology assessmentIn silico trialsKnowledgeModeling and simulation (M&S)Software platformSynthetic control armsSystems biologySystems pharmacologyMore Related Videos
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