PharmPK Discussion - Analysis of placebos in placebo controlled studies

• On 16 May 1996 at 21:57:42, DGarg8838.aaa.aol.com sent the message
  

  
  I do not know about any FDA regulations or guidelines for analysis of placebo
  samples. We conduct many Phase I studies for phramaceutical and biotech
  companies. Many protocols clearly indicate that the blind will be broken for
  the purpose of the analytical laboratory and only subjects on active drug
  will be analyzed.
  
  Placebo controlled study designs are important for the purpose of safety,
  efficacy. If a protocol is measuring some pharmacodynamic parameter or
  surrogate end point then one will collect the information on Placebo
  subjects. We are currently involved in a protocol which requires platelet
  aggregation studies with ADP, TRAP and Arachidonic Acid and the lab is
  measuring the platelet aggregation on all subjects. However the analytical
  lab will measure drug concentrations on only the subjects who received active
  drug.
  
  I have not seen too many Open Label studies with Placebo control as suggested
  by Parsad in his E-mail. I donot know the significance of placebo in an open
  label study. Samples from Placebo subjects may be useful to understand the
  baseline noise of an analytical procedure.
  
  Dyal Garg
  Clinical Research Services, Inc.
  8838 Indian River Run
  Boynton Beach, FL 33437
  Phone:407-737-3954
  Fax: 407-732-1941
  
  

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Copyright 1995-2014 David W. A. Bourne (david@boomer.org)