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. 2021 Jul 11;8(8):1730–1737. doi: 10.1002/acn3.51423

Table 1.

Toward a future state of metabolism‐based treatment for epilepsy

Challenges and opportunities
Challenge Opportunity
Insufficient rigor in pre‐clinical and clinical studies
  • Adherence to principles of rigor, reproducibility, sex as a biological variable, and including appropriate representation in both preclinical and clinical studies

  • Reporting adherence to published rigor guidelines

Animal models do not mirror the human condition
  • Studying species that more closely mimic human pathophysiology

  • In silico modeling human physiology

  • Basic science studies in humans

Incomplete understanding of network properties of metabolism Build on existing knowledge, tools, and approaches (e.g., by the BRAIN Initiative) to investigate metabolic circuits
Missing or incomplete data sets Adherence to data sharing guidelines
Clinical trial recruitment
  • Optimizing remote participation

  • Use of monitoring devices

  • Novel clinical trial designs (using appropriate statistics)

Poor relevance of measured clinical trial outcomes to patient wellbeing Inclusion of advocacy organizations
Neglect of individual biological differences in clinical trials Data‐intensive sub‐analysis methods to capitalize on potentially important biological information
Excessive proportion of negative trial results Rigorous failure analysis
No validated biomarkers Development of biomarkers (at various stages of investigation) within the BEST framework for future clinical studies