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