Regulatory Perspective on Navigating the Safety Vs Toxicity Hurdle to Achieve Success in Clinical Trials by Agreeing on a Standardized Approach for Dose Escalation & Endpoints
Time: 9:30 am
day: Day Two
Details:
- Addressing trial design concerns to ensure the risks and benefits are well balanced
- Coupling preclinical knowledge to find the right dose that’s both safe and efficacious in the clinical realm
- How to anticipate adverse events to propose a mitigating strategy
