Part I: Foundations of Clinical Science and Viscosupplementation
Master the fundamental science, regulatory pathways, and clinical trial methodology that form the bedrock of evidence-based clinical conversations. This foundation enables you to speak with authority about drug development, statistical interpretation, and hyaluronic acid science.
Core Clinical Competency:
Understanding clinical trial phases and regulatory pathways to interpret study credibility and applicability
- Phase I-IV trial objectives and design principles
- FDA regulatory branches (CDER, CBER, CDRH) and device vs. drug pathways
- Controls in clinical studies: placebo, active control, arthrocentesis
- Industry sponsorship impact and Good Clinical Practice principles
Clinical Application:
Discuss study credibility using precise regulatory terminology and explain why different control types validate different clinical questions
Core Clinical Competency:
Deep understanding of HA sourcing, molecular weight, and formulation science to differentiate products clinically
- Knee OA pathophysiology and universal indication framework
- Bacterial fermentation vs. avian sourcing: clinical implications
- Molecular weight concepts and cross-linking technologies
- Specific product formulations: NASHA®, cross-linking, stabilization
Clinical Application:
Connect formulation science to clinical outcomes and address source-related contraindications appropriately
Core Clinical Competency:
Statistical literacy to interpret p-values, understand non-inferiority trials, and distinguish statistical from clinical significance
- RCT hierarchy: superiority vs. non-inferiority trial design
- Blinding methodology and bias reduction strategies
- P-values interpretation and the power of non-inferiority
- When "not significant" doesn't mean "no effect"
Clinical Application:
Explain complex statistical concepts in clinically relevant terms and handle p-value objections professionally