From: mark.e.sale@gsk.com
Subject: [NMusers] Comparison of simulated trials to real trials
Date:Tue, 6 Aug 2002 13:21:38 -0400

Dear Colleagues,
 I'm look for examples where clinical trial simulations have been done,  and the trials then
done (as simulated), with both results published.  An example is the (now famous) work by Mike
Hale on Mycophenolate with the simulation published (as a technical report)  and the actual
trial results  published (van Gelder T. Hilbrands LB. Vanrenterghem Y. Weimar W. de Fijter JW.
Squifflet JP. Hene RJ. Verpooten GA. Navarro MT. Hale MD. Nicholls AJ. A randomized
double-blind, multicenter plasma concentration controlled study of the safety and efficacy of
oral mycophenolate mofetil for the 
prevention of acute rejection after kidney transplantation. Transplantation.
68(2):261-6, 1999 Jul 27) for comparison.  There seem to be a few abstract: we have one
presented as an abstract.  "A method to assess congruence of a clinical trial simulation and a
phase II clinical trial"  There also were two abstracts by Peck et al at ASCPT 2000 ("PK/PD
modeling of moxonidiena and simulation of a phase 3 trial" and "Simulation of Clinical Trials:
Lessons Learned"), and one full paper 

(Kimko HC. Reele SS. Holford NH. Peck CC. Prediction of the outcome of a phase 3 clinical trial
of an antischizophrenic agent (quetiapine fumarate) by simulation with a population
pharmacokinetic and pharmacodynamic model

  Other examples?
Thanks

Mark Sale M.D.
Global Director, Research Modelling and Simulation
Clinical Pharmacology and Discovery Medicine
GlaxoSmithKline

------------------


From:JPEREZRU@PRDBE.jnj.com 
Subject:RE: [NMusers] Comparison of simulated trials to real trials
Date: 07-Aug-2002 09:31 

 Dear, 
   
 I think this could be other example. 
   
 Veyrat-Follet C, Bruno R, Olivares R, Rhodes GR, Chaikin P. 

Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage optimization.
Clin Pharmacol Ther. 2000 Dec;68(6):677-87. 
  
Best regards.
Juan Jose Perez Ruixo, Pharm.D, Ph.D. 
Senior Scientist, Advanced PK/PD Modelling &Simulation  
Global Clinical Pharmacokinetics and Clinical Pharmacodynamics. 
Johnson & Johnson Pharmaceutical R&D. 
------------------

From:mark.e.sale@gsk.com
Subject:RE: [NMusers] Comparison of simulated trials to real trials
Date:Wed, 7 Aug 2002 10:15:29 -0400

Thanks Juan Jose, 
But, I think that that simulation led to a decision not to do the phase III trial.  The simulations were compared
to the phase II trial from which they were derived, at least by my reading of the paper.


Mark
------------------