Whitepapers and Resources

The following whitepapers and resources are intended as starting points for the CT Virtual Patients working group.

  1. The statistical plan background from the MDIC CM&S Virtual Patient mock submission.. This is uses an engineering model instead of historical data as the Virtual Patient, the Bayesian prior. However, it gives good conceptual information on the method.
  2. Binomial R-Code This is R code demonstrating the VP framework using a binomial.
  3. An implementation example of Incorporation of stochastic engineering models as prior information in Bayesian medical device trials. This is a white paper showing how to implement the VP statistical framework for an OPC trial.
  4. White Paper OPC R-Code This is the R code demonstrating the white paper information for the OPC trial.
  5. Shiny Graphical User Interface (GUI) for Virtual Patient: Updated to address One- or Two-Sided Loss Functions.  (Please Note – Currently the Shiny account is limited to 25 hours per month.  We will continuously evaluate our need for expanded access).
  6. WebEx Recording for Statisticians: From 28-JUL-2016
  7. BD Case Example: WebEx from 26-AUG-2016
  8. BSCI Case Example: RCT WebEx from 09-DEC-2016

Additional information that you may find useful:

  1. Incorporation of stochastic engineering models as prior information in Bayesian medical device trials, Haddad, et al., Journal of Biopharmaceutical Statistics (Online).
  2. MDICx – Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
  3. MDICx – Virtual Patient R Code Access and Case Examples
  4. Use of historical control data for assessing treatment effects in clinical trials, Viele, et al., Pharm Stat. 2014 ; 13(1): 41–54. doi:10.1002/pst.1589
  5. Gamalo, M. A., Tiwari, R. C. and LaVange, L. M. (2014), Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products. Pharmaceutical Stat., 13: 25–40. doi:10.1002/pst.1588
  6. Zhao, Y.Zalkikar, J.Tiwari, R. C., and LaVange, L. M. (2014), A Bayesian Approach for Benefit-Risk AssessmentStatistics in Biopharmaceutical Research, 6, 326337.
  7. Rietbergen C.Klugkist I.Janssen K.J.M.Moons K.G.M.Hoijtink H.J.A. (2011). Incorporation of historical data in the analysis of randomized therapeutic trials. Contemporary Clinical Trials,  32  (6) , pp. 848-855.