Improving natural product research translation: From source to clinical trial

Area of Science:

• Integrative biology
• Translational science
• Natural product research

Background:

• Significant interest exists in the health effects of natural products (NPs), including dietary supplements and foods.
• However, promising preclinical NP research often fails to translate into successful clinical trial (CT) outcomes.
• Clinical trials, particularly phase III, are expensive and demand meticulous planning for optimal data acquisition.

Purpose of the Study:

• To enhance the translation of natural product research into actionable clinical trial outcomes.
• To identify and promote best practices across the continuum of natural product research and clinical application.
• To foster a more effective bridge between preclinical NP studies and clinical trial design and execution.

Main Methods:

• Convened a transdisciplinary workshop in September 2018 focused on improving NP research to CT translation.
• Facilitated discussions on key areas including NP characterization, quality control, and model system validity.
• Emphasized the importance of rigorous experimental design, interpretation, reporting, and transparency.

Main Results:

• Replicability and successful translation are contingent upon rigor throughout the NP research process.
• Key practices include robust NP characterization, validated predictive models, and control of experimental artifacts.
• Prioritizing research questions based on convergent data and public health needs is crucial.

Conclusions:

• Implementing standardized rigorous practices in NP research, from characterization to reporting, is essential for successful translation to clinical trials.
• Coordinated implementation of these best practices will improve the knowledge gained from future NP research.
• This approach aims to enhance the impact of natural product research on public health.