SPCD

Sequential Parallel Comparison Design

  • The Sequential Parallel Comparison Design aims to:
    • Reduce the impact of high placebo response
    • Decrease study sample size
    • Accepted and published on by FDA
  • The SPCD model has two relatively short phases of treatment of equal duration
  • Only non-responders to placebo (P) during the first phase are included in the analyses of the second phase
  • Unbalanced randomization (2:3:3 assignment of DD, PP, and PD)
  • Analysis can be conducted by Maurizio Fava, MD and David Schoenfeld, PhD
  • Four authors from FDA have published an article discussing two of the several SPCD formats www.ncbi.nlm.nih.gov/pubmed/21540126
  • The SPCD methodology is licensed to Pharmaceutical Product Development, LLC (PPD), which PPD brands as Trimentumâ„¢. A one-time license fee is payable to PPD, for more information please visit www.ppdi.com/trimentum.

 

Example of an SPCD Design:

SPCD