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SUMMARY:Predictive analytic modelling in clinical trials  (patient recruit
 ment\, randomization and drug supply)  - Vladimir Anisimov\,  Qunitiles
DTSTART:20121009T133000Z
DTEND:20121009T143000Z
UID:TALK39605@talks.cam.ac.uk
CONTACT:Dr Jack Bowden
DESCRIPTION:The advanced analytic methodology for modelling and predicting
  stochastic processes describing the behaviour in time of different stages
  in Phase III multicentre clinical trials is discussed. \nA statistical me
 thodology for predictive patient's recruitment modelling is developed in [
 1\,2\,4] where the patient's flows are modelled by using Poisson processes
  with random delays and gamma distributed rates (Poisson-gamma model). ML 
 and Bayesian techniques for estimating parameters and asymptotic approxima
 tions for the mean and predictive bounds in time for the number of patient
 s recruited in the regions and for time to complete trial are developed. T
 he optimal number of clinical centres and trial performance can be also ev
 aluated. \nAnalytic technique for predicting in time the number of differe
 nt events in trials with waiting time to response is developed [5]. The cl
 osed-form expressions for predictive distributions are derived and used in
  oncology trials. \nAnalytic technique for predicting in time randomisatio
 n processes in centres/regions is developed and the impact of stratificati
 on on sample size is investigated [3\,4]. A risk-based supply modelling to
 ol based on these results is developed [2]. \nSoftware tools in R supporti
 ng these techniques are created. These tools are implemented on R&D GSK le
 vel and already led to significant benefits and cost savings.\n\nReference
 s\n\n1.	Anisimov\, V.V.\, Fedorov\, V.V.\, Modeling\, prediction and adapt
 ive adjustment of recruitment in multicentre trials. Statistics in Medicin
 e\, v. 26\, No. 27\, 2007\, pp. 4958-4975.\n\n2.	Anisimov\, V.V.\, Predict
 ive modelling of recruitment and drug supply in multicenter clinical trial
 s. Proc. of the Joint Statistical Meeting\, Washington\, USA\, August\, 20
 09\, pp. 1248-1259.\n\n3.	Anisimov\, V.V.\, Effects of unstratified and ce
 ntre-stratified randomization in multicentre clinical trials. Pharmaceutic
 al Statistics\, v. 10\, iss. 1\, 2011\, pp. 50-59.\n\n4.	Anisimov\, V.V.\,
  Statistical modeling of clinical trials (recruitment and randomization)\,
  Communications in Statistics - Theory and Methods\, 40: 19-20\, 2011\, pp
 . 3684-3699. \n\n5.	Anisimov\, V.V.\, Predictive event modelling in multic
 entre clinical trials with waiting time to response\, Pharmaceutical Stati
 stics\, v. 10\, iss. 6\, 2011\, pp. 517-522.\n
LOCATION:Large  Seminar Room\, 1st Floor\, Institute of Public Health\, Un
 iversity Forvie Site\, Robinson Way\, Cambridge
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