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