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R Papers (, R/Pharma Papers)

1. Exploring Use of R for Clinical Trials, Kalpesh Prajapati

2. Is R language reliable and efficient tool for programming SAS datasets or just art for art’s sake?, Piotr Podlewsk [DPLYR, SDTMs]

3. Clinical Trial Datasets (CDISC - SDTM/ADaM) Using R, Prasanna Murugesan [Compare SAS Code, Presentation]

4. A Gentle Introduction to R From A SAS Programmer's Perspective, Saranya Duraisamy [Beginner Level]

5. Python and R made easy for the SAS® Programmer, Janet Li [Compare Code]

6. R for SAS programmers: It’s different, but friendly, Friedrich Schuster

7. SAS® and R - stop choosing, start combining and get benefits!, Diana Bulaienko

8. SAS and R Playing Nice Together, David Edwards, Bella Feng, Brian Schultheiss

9. Can clinical trial data sets (CDSIC - SDTM/ADaM) be generated using R? Blog


10. R: Validation Hub - A RISK-BASED APPROACH FOR ASSESSING R PACKAGE ACCURACY WITHIN A VALIDATED INFRASTRUCTURE [FDA, IQ/OQ/PQ]


11. CRAN Task View: Clinical Trial Design, Monitoring, and Analysis (packages)

12. SAS® and R Working Together, Matthew Cohen [Date formats]

13. Best Practices for Reproducible Package Management in R

14. Techniques for writing robust R programs, Martin Gregory , Merck Serono [Presentation, Defensive Programming]

15. How do I select an R package for my clinical workflow?, Sean Lopp & Phil Bowsher [Validation, Documentation, Version Control, Common FAQs]

16. The Challenges of Validating R [Presentation]

17. Using R to Drive Agility in Clinical Reporting [GSK Presentation]

18. CDISC Dataset-XML – A new Dataset Structure for Clinical Trial Data Transport for Future Drug Submissions, Jörg Dillert [R4CDISC, R4DSXML]

19. End to End Interactive TLF using R Shiny, Rohit Banga


20. Is there any better option than SAS for TLFs? Yes, there R!, Niccolo Bassani [Presentation - ddply(), Proc REPORT]

21. A quick introduction to plyr, Sean Anderson [PLYR package splits data]

22. Using R Programming for Clinical Trial Data Analysis Blog

23. The SAS® Versus R Debate in Industry and Academia, Chelsea Loomis Lofland, Rebecca Ottesen [Compare SAS and R]

24. Using R in a Regulatory Environment: some FDA perspectives

25. Using R: Perspectives of a FDA Statistial Reviewer [Presentation]


26. R-Pharma Papers

27. R for Clinical Reporting, Yes - Let's Explore It!, Hao Meng, Yating Gu, Yeshashwini Chenna (SASxport, sas7bdat, dplyr, White Paper)


28. Generating ADaM Compliant ADSL Dataset Using R, Vipin Kumpawat [SDTM, White Paper, Left Variable Assignment]


29. Generating TFLs in R - Challenges and Successes compared to SAS, Amol Waykar, Kevin Kramer, Kalyani Komarasetti, Andrew Miskell

30. Using the R interface in SAS ® to Call R Functions and Transfer Data, Bruce Gilsen

31. Expand Your Skills from SAS® to R with No Complications, Andrii Korchak [DPLYR, %>%]

32. Simulation in SAS with Comparisons to R, Chelsea Loomis Lofland, Rebecca Ottesen

33. Normal is Boring, Let’s be Shiny: Managing Projects in Statistical Programming Using the RStudio® Shiny® App, Girish Kankipati, Hao Meng


34. Building Automations for Generating R and SAS Code Supporting Visualizations Across Multiple Therapeutic Areas, Anastasia Alexeeva, William Martersteck, and Mei Zhao

35. Effective Exposure-Response Data Visualization and Report by Combining the Power of R and SAS Programming, Shuozhi Zuo, Hong Yan

36. A Brief Introduction to Performing Statistical Analysis in SAS, R & Python, Erica Goodrich, Daniel Sturgeon

37. The Power of Data Visualization in R, Babych Oleksandr

38. Open-NCA – R Scripts for CDISC-based Pharmacokinetic Analysis, Peter Schaefer

39. Statistical Computing Environments in CDER, Paul Schuette

40. Use of R Script to Create Trial Summary (ts.xpt) Domains for Nonclinical SEND Studies, Bob Friedman, Xybion; Anthony Fata, William Varady, William Houser, Kevin Snyder

41. R Package Oriented Software Development Life Cycle in Regulated Clinical Trial Environments, Yalin Zhu, Rinki Jajoo, Clare Bai, Sarad Nepal, Daniel Woodie, Keaven Anderson, Yilong Zhang [Presentation, GxP, SDLC]


42. R for SDTM and ADaM Data [Poster]

43. R syntax for SAS programmers, Max Cherny [Beginner, Tidyverse, SDTMs, White Paper]


44. Creating Graphs Simply with SAS® or R, John O’Leary, Jaclyn Scholl

45. Techniques for writing robust R programs, Martin Gregory , Merck Serono

46. Seamless R And SAS: For Shiny Visualizations, Pragathi Kotha Venkata [Presentation]

47. R for the Analysis of Clinical Data, Greg Jones [Presentation]

48. Numerical validation as a critical aspect in bringing R to the Clinical Research, Adrian Olszewski [R and SAS differences]

49. How much is it? Validation of Open-Source-Software Using the example of R, Peter Bewerunge [IQ/OQ/PQ]

50. Introducing LearnR package

51. An Automation Proof of Concept of Periodic Reporting via R Shiny [PSUR/DSUR, Presentation]


52. Open-Source Development for Traditional Clinical Reporting, Mike Stackhouse, Nathan Kosiba

53. r2rtf – an R Package to Produce Rich Text Format (RTF) Tables and Figures, Siruo Wang, Simiao Ye, Keaven Anderson, Yilong Zhang

54. Validating R – Part of the Uphill Battle in the Pharmaceutical Industry, Peter Schaefer and Debra Fontana [Installation, Operational, Performance Qualifications]


55. A Beginner’s Babblefish: Basic Skills for Translation Between R and SAS, Sarah Woodruff

56. Using R to Validate Results of Other Programming Environments, Nikhil Abhyankar, Vidyagouri Prayag


57. Drug Safety Reporting- now and then, David Garbutt

58. Exploring R as a validation tool for statistical programming in clinical trials, Uday Preetham Palukuru, Runcheng Li, Nileshkumar Patel, Changhong Shi [Extract rtf files]

59. Implementing and Achieving Organizational R Training Objectives, Jeff Cheng, Abhilash Chimbirithy, Amy Gillespie, and Yilong Zhang

60. Using R from end to end: CDISC SDTM and ADaM into .xpt and output generation, Antonio Rodriguez [Presentation]

61. Peaceful Co-existence: R and SAS, Martin Gregory, Manuel Cornes

62. ValidR Enterprise: Developing an R Validation Framework, Andy Nicholls


63. Defining Script Metadata for Sharing: Using phuse R package as an example, Hanming Tu [Presentation, HOW] [ValTools]

64. Making data mapping process easier and smarter with SAS and R, Andrii Artemchuk [PresentationSAS Macros]

65. Sample size: a couple more hints to handle it right using SAS and R, Andrii Artemchuk [Presentation]

66. Pan-pharma Industry collaboration - new horizon, success stories [Presentation]

67. Closing the Gap, Creating and End-to-End R package toolkit for the clinical reporting pipeline, Eli Miller, Ben Straub [Presentation]

68. Introduction to R for Statistical Programmers [Presentation]

69. Creating and End-to-End R Package Toolkit for the Clinical Reporting Pipeline, Eli Miller, Ben Straub [Presentation]

70. The Practical R [book]

71. R Programming Data frame: Exercises, Practice, Solution

72. Programming R

73. Create a Demographics Table with gt Package in R

74. Open-Source Development for Traditional Clinical Reporting, Mike Stackhouse, Nathan Kosiba

75. R Validation: Approaches and Considerations, Phil Bowsher, Sean Lopp

76. Transitioning to R for Clinical Submissions [Presentation, Step by  Step Instructions]

  1. Add RStudio as a Trusted Vendor
  2. Get users off the desktop
  3. Get a Server (cloud or onsite) for Development
  4. Create an R version and Package plan
  5. Created a Validated repository of packages based on Plan in Step4
  6. As time goes on, Don't upgrade R
  7. Validate your internal packages & UDFs
  8. Determine your method for data management & TLFs
  9. Harden Production and not RStudio
  10. Create a R cloud strategy for clinical reporting

77. Harmonizing your Traditional Workflow with R, Nick Masel, Mike Stackhouse [Presentation]

78. Patient Narrative Generation, PROC Report/Stream vs R - Markdown, Yuanyuan Gu and Mengmeng Zhao

79. Using R-Shiny Capabilities in Clinical Programming to create Applications, Prakasam R, Sujatha Kandukuri, Tyagrajan Swaminathan


80. Make your Data shine with R-Shiny, Pavan Vemuri [Patient Profiles, R code]


81. Using R Markdown to Generate Clinical Trials Summary Report [Presentation]

82. Using R Shiny to Explore Clinical Trial Data, Yaoxian Yuan, Jiaying Wu

83.  A Process to Validate Internal Developed R Package under Regulatory Environment, Madhusudhan Ginnaram, Simiao Ye, Yalin Zhu, Yilong Zhang, Amin Shiraz

84. The reporter package: A Powerful and Easy-to-use Reporting Package for R, David Bosak

85. Open-Source Development for Traditional Clinical Reporting, Mike Stackhouse, Nathan Kosiba

86. Table-Based Data Visualization using R, Matthew Kumar [Presentation]

87. R Package Development at Novo Nordisk [Presentation, Submission]

88. Data Handling with SASMarkdown in R Studio, Nandukrishnan, Senju Mani

89. Shiny for Submissions, Phil Bowsher, Eric Nantz

90. A Beginner’s Roadmap to Map Functions for Clinical Reporting in R, Samuel Curlee, Gabriela Piasecki, Xiaoqing Tang, Wenjian Xu

91. FY2018 Regulatory Science Report: Data Analytics [Shiny]

92. Implementing A Risk-based Approach to R Validation, Andy Nicholls [Presentation, Riskmetric]


93. The Data Validation Cookbook, Mark P.J [Book]

94. Using the R interface in SAS ® to Call R Functions and Transfer Data, Bruce Gilsen

95. An Introduction to Obtaining Test Statistics and P-Values from SAS® and R for Clinical Reporting, Brian Varney

96. R Tables via GT for Regulatory Submissions, Phil Bowsher, Rich Iannone


97. Building an Internal R Package for Statistical Analysis and Reporting in Clinical Trials: A SAS User’s Perspective, Huei-Ling Chen, Heng Zhou, Nan Xiao

98. R Package Quality & Validation: Current Landscape, Phil Bowsher


99. admiralonco - the cross-company R package for Oncology admirers, Neharika Sharma, Matthew Marino

100. R Package Qualification: Automation and Documentation in a Regulated  Environment, Paul Bernecki, Nicole Jones, Uday Preetham Palukuru, Abhilash Vasu Chimbirithy


101. Using R to Automate Clinical Trial Data Quality Review, Melanie Hullings, Emily Murphy, Andrew Burd, Derek Lawrence, Michelle Cohen

102. Real Projects, Real Transition, Really Revolutionary – Transitioning to R for Biometrics Work, Danielle Stephenson, Rebekah Oster and Alyssa Wittle



103. Are you planning to create/validate CDISC data set in R? Here is a step-bystep guide!, Ganesh chandra Gupta [SDTMs, ADaMs, White Paper]


104. R Package Quality and Validation, Phil Bowsher [Presentation]

105. INTRODUCTION TO THE R PACKAGE 'RISKMETRIC' [Validation Hub, Video]


106. R String Manipulation Functions vs SAS Character Functions, Jagadish Katam [stringr, str_view_all()]

  • str_detect() vs find(), filter(CM,str_detect(CONMED,“RIFAP”))
  • paste() vs catx(), CM$CONMEDOS <- paste(CM$CONMED,CM$DOSE)
  • strsplit() vs scan(), CM$CONMED <- sapply(strsplit(as.character(CM$CONMEDOS), "/"),"[", 1)
  • str_extract() vs substr(), CM$DOSE <- str_extract(CM$CONMEDOS, "\\d+\\s\\w+|\\d+\\.\\d\\s\\w+")
  • str_replace() vs tranwrd(), CM$CONMEDOS <- str_replace(CM$CONMEDOS, "mg", "mcg")

107. External R Package Qualification Process in Regulated Environment, Jane Liao, Fansen Kong, and Yilong Zhang

108. Analysis and Reporting in Regulated Clinical Trial Environment using R, Peikun Wu, Uday Preetham Palukuru, Yiwen Luo, Sarad Nepal, Yilong Zhang

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