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Biometric Research Program (BRP)

Computational and Systems Biology Branch. Drug Discovery and Pre-Clinical Development. Computational and Systems Biology. Online Sample Size Calculation. Predictive Biomarkers in Phase II/III Clinical Trials. Optimal Two-Stage Designs for Phase II Clinical Trials. Integrated Phase II/III Study. Sample Size Planning for Developing Classifiers. Design, Monitoring and Analysis of Bayesian Basket Discovery Trials. Bayesian Phase II Single Arm Clinical Trials. Accelerated Titration Design Software. Our resear...

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Biometric Research Program (BRP) | brb.nci.nih.gov Reviews

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Computational and Systems Biology Branch. Drug Discovery and Pre-Clinical Development. Computational and Systems Biology. Online Sample Size Calculation. Predictive Biomarkers in Phase II/III Clinical Trials. Optimal Two-Stage Designs for Phase II Clinical Trials. Integrated Phase II/III Study. Sample Size Planning for Developing Classifiers. Design, Monitoring and Analysis of Bayesian Basket Discovery Trials. Bayesian Phase II Single Arm Clinical Trials. Accelerated Titration Design Software. Our resear...

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Biometric Research Program (BRP) | brb.nci.nih.gov Reviews

https://brb.nci.nih.gov

Computational and Systems Biology Branch. Drug Discovery and Pre-Clinical Development. Computational and Systems Biology. Online Sample Size Calculation. Predictive Biomarkers in Phase II/III Clinical Trials. Optimal Two-Stage Designs for Phase II Clinical Trials. Integrated Phase II/III Study. Sample Size Planning for Developing Classifiers. Design, Monitoring and Analysis of Bayesian Basket Discovery Trials. Bayesian Phase II Single Arm Clinical Trials. Accelerated Titration Design Software. Our resear...

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brb.nci.nih.gov

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Sample size planning for an integrated phase II/III study

https://brb.nci.nih.gov/brb/samplesize/ip23study1.html

Sample Size Planning for an Integrated Phase II/III Study. This program calculates either simulated or an approximate expected time, expected sample size and final power for. The integrated phase II/III design. A single randomized study with overall survival as the endpoint. A single study with overall survival as the endpoint with a futility analysis based on survival. Separate randomized phase II followed by phase III. Based on OS using approximations. Median Overall Survival (OS) time for Control Group.

2

Sample Size Calculation

https://brb.nci.nih.gov/brb/samplesize/index1.html

Biomarker Targeted Randomized Design. Targeted design randomizes only marker positive patients to treatment or control arm. Untargeted design does not measure marker and randomizes all who otherwise are eligible. Biomarker Stratified Randomized Design. Stratified design randomizes both marker positive and negative patients.

3

BRB-ArrayTools

https://brb.nci.nih.gov/BRB-ArrayTools.html

Developed by: Dr. Richard Simon and BRB-ArrayTools Development Team. Next Generation Sequencing Data. BRB-ArrayTools is free for non-commercial use. Download BRB-ArrayTools v4.5.1 Stable. Download BRB-Digital Gene Expression: Pre-Process RNA-Seq files. BRB-ArrayTools v4.6.0 Beta 1 is coming soon. BRB-Digital Gene Expression will have a variant calling analysis pipeline in the next release. What data types does our software handle? RNA-Seq count data processed through Galaxy web tools.

4

Sample Size Planning for Developing Classifiers Using High Dimensional Data

https://brb.nci.nih.gov/brb/samplesize/samplesize4GE.html

Sample Size Planning for Developing Classifiers Using High Dimensional Data. Kevin Dobbin and Richard Simon, Biostatistics. Kevin Dobbin, Yingdong Zhao and Richard Simon, Clinical Cancer Research. Enter standardized fold change [ 0.2 ]. Enter number of genes on array [ 50 ]. Enter population prevalence in largest group (2 groups only) [ between 0.5 and 0.85 ]. The program only considers sample sizes below 300. If 300 samples are needed, then an error message is returned indicating this.

5

Optimal Two-Stage Designs For Phase II Clinical Trials

https://brb.nci.nih.gov/brb/samplesize/otsd.html

Optimal Two-Stage Designs For Phase II Clinical Trials. Richard Simon, Controlled Clinical Trials. Enter probability of accepting poor drug (alpha) [between 0 and 0.3 only]. Enter probability of rejecting good drug (beta) [between 0 and 0.3 only]. Enter response probabilty of poor drug (P0) [between 0 and 1]. Enter response probability of good drug (P1) [P1 should be greater than P0].

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