The following whitepapers and resources are intended as starting points for the CT Virtual Patients working group.
- 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.
- Binomial R-Code This is R code demonstrating the VP framework using a binomial.
- 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.
- White Paper OPC R-Code This is the R code demonstrating the white paper information for the OPC trial.
- 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).
- WebEx Recording for Statisticians: From 28-JUL-2016
- BD Case Example: WebEx from 26-AUG-2016
- BSCI Case Example: RCT WebEx from 09-DEC-2016
Additional information that you may find useful:
- Incorporation of stochastic engineering models as prior information in Bayesian medical device trials, Haddad, et al., Journal of Biopharmaceutical Statistics (Online).
- MDICx – Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
- MDICx – Virtual Patient R Code Access and Case Examples
- 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
- 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
- Zhao, Y., Zalkikar, J., Tiwari, R. C., and LaVange, L. M. (2014), A Bayesian Approach for Benefit-Risk Assessment, Statistics in Biopharmaceutical Research, 6, 326–337.
- 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.