Establishing Early Efficacy in Depression Clinical Trials
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This article is featured on The Association of Clinical Research Professionals (ACRP). Bradley D. Vince, DO and Sheldon H. Preskorn, MD discuss the process of developing a new molecular entity (NME) for FDA approval and strategies for establishing early efficacy.
Key points covered:
- Importance of early efficacy assessments in determining a drug’s potential effectiveness
- Use of rating scales in assessing treatment response in depression studies
- Role of biomarkers as surrogates for efficacy