General Comments and Recommendations

1. CDDS recommends that the draft guidance be accompanied by a glossary of technical terms used in the document. Among terms that are used interchangeably in the guidance that should be defined are the following:
2. 1. study, clinical trial, investigation
   2. pharmacodynamics, pharmacodynamic effects, clinical effects
   3. surrogate endpoint, clinical endpoint
   4. efficacy, effectiveness
   5. concentration, blood level, exposure
   6. replication, substantiation, confirmation
   7. empirical, mechanistic, model, modeling
   8. statistically very powerful finding, extreme p-value
3. We recommend that the draft guidance be expanded or supplemented to incorporate a consideration of the following issues and concepts:
4. 1. surrogate vs clinical endpoints
   2. pharmacological and biological modeling vis-á-vis clinical trial designs and data analysis
   3. effectiveness as a continuum of degrees of effectiveness versus as an all-or-none phenomenon

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