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Session 4: Special Topics for Clinical Research
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
- Adequate and Well-controlled Trials
- Adaptive Study Designs
- Comparative Effectiveness Research (CER)
- Patient Reported Outcomes
- Surrogate Endpoints
- The Animal Efficacy Rule
- Qualification of Drug Development Tools
- Foreign Clinical Trials
- Changes to the Investigational Drug
- Financial Disclosure by Clinical Investigators