Added in more references for training & links and a new news page for…

… pilot 3 (#12)

Co-authored-by: Christina Fillmore <[email protected]>

02R-tist.qmd

@@ -28,7 +28,13 @@ Substantial free training is available for R. A few links to get you started are
 
     -   [Efficicient R Programming - Colin Gillespie, Robin Lovelace](https://bookdown.org/csgillespie/efficientR/)
 
-    -   [Bookdown](https://bookdown.org/)
+    -   [quarto](https://quarto.org)
+
+    -   [Tidyverse Style Guide](https://style.tidyverse.org/)
+
+    -   [rOpenSci Package development](https://devguide.ropensci.org/building.html)
+
+    -   [R Packages (2e)](https://r-pkgs.org)
 
 -   Blogs/ Videos
 

index.qmd

@@ -31,11 +31,11 @@ The Application and Implementation of Medical Statistics (AIMS) Special Interest
 
 ::: long-hex
 ### Design and Reporting
--   [SDTM, ADaM & TFLs](https://pharmaverse.org/e2eclinical/)
+-   [SDTM, ADaM   & TFLs](https://pharmaverse.org/e2eclinical/)
 
 -   [Displays](https://rconsortium.github.io/rtrs-wg/)
 
--   [Statistical Methods](https://psiaims.github.io/CAMIS/)
+-   [Statistical Methods (CAMIS)](https://psiaims.github.io/CAMIS/)
 
 :::
 
@@ -49,6 +49,7 @@ The Application and Implementation of Medical Statistics (AIMS) Special Interest
 ::: long-hex 
 ### Other
 -   [Collaborations](https://psiaims.github.io/website/rcollaborations.html)
+-   [PHUSE R for Submissions](https://sway.office.com/PdIb3DFE9uLJtrRP?ref=Link&loc=play)
 :::
 
 

posts/test/CAMIS2023.qmd

@@ -0,0 +1,18 @@
+---
+title: "2023: A Year of Progress for PHUSE CAMIS Working Group"
+description: "PHUSE CAMIS WG describe their progress during 2023"
+author:
+  - name: Lyn Taylor
+    url: https://psiaims.github.io/website/
+
+date: 11-20-2023
+categories: [CAMIS, Comparison of Software] # self-defined categories
+draft: false # setting this to `true` will prevent your post from appearing on your listing page until you're ready!
+---
+
+As we draw towards the end of 2023, the PHUSE CAMIS Working Group reflect on their key progress and successes this year.
+The CAMIS repository went live in January 2023, drawing on the content from the PHUSE CSRMLW project.  This searchable repo compares analysis method implementations in software (CAMIS) such as SAS, R and python.  
+The White Paper was published in June, which highlighted the importance of clearly specifying your analysis, such that it can be replicated in different software, and isn’t relying on default options which can be different.
+For more complex analyses, it can still be hard to understand what defaults and algorithms your software is using, so the team focused 2023 on expanding our repo content, comparing SAS vs R methods.  By August, we had covered the following topics in the repo: quartiles, rounding, anova, mmrm, cmh, log-rank, cox-ph, mcnemar’s test, kruskal-wallis test and logistic. October saw the launch of the sub-working group: CAMIS-Oncology, led by Somasekhar Sriadibhatla (AstraZeneca).  This team will focus specifically on oncology endpoints and analyzing them in SAS, R and Python.  The CAMIS team have expanded in membership during 2023 presenting at numerous conferences around the world. In November, we welcomed Harshal Khanolkar (NovoNordisk), to join the leadership team alongside Christina Fillmore (GSK) and Lyn Taylor (PAREXEL).  Our focus for 2024, will be on the creation of additional content for the repo, and sharing awareness of the project across the medical research and wider community.  We’d like to take this opportunity to thank all of our team members and contributors, and encourage everyone to check out the repository and help us to grow our content CAMIS (psiaims.github.io).  If you would like to join the team please get in touch through the repo.
+
+    ![](../../images/CAMIS - 2023 update.jpg)

posts/test/FDApilot3.qmd

@@ -0,0 +1,17 @@
+---
+title: "FDA Pilot 3 submission"
+description: "R Submissions Working Group successfully submitted an R-based test submission pilot 3 package through the FDA eCTD gateway"
+author:
+  - name: Lyn Taylor
+    url: https://psiaims.github.io/website/
+
+date: 28-08-2023
+categories: [Regulatory, FDA] # self-defined categories
+draft: false # setting this to `true` will prevent your post from appearing on your listing page until you're ready!
+---
+
+The R Consortium is pleased to announce that on August 28, 2023, the R Submissions Working Group successfully submitted an R-based test submission *pilot 3* package through the FDA eCTD gateway! The FDA CDER staff are now able to begin their evaluation process. All submission materials can be found at: <https://github.com/RConsortium/submissions-pilot3-adam-to-fda> 
+
+The *pilot 3* test submission is an example of an all R submission package following eCTD specifications. These include the installation and loading of the proprietary {pilot3} R package and other open-source R packages, R scripts for the analysis data model (ADaM) datasets from *pilot 3* and tables, listings, figures (TLFs) from *pilot 1*, analysis data reviewer's guide (adrg), and other required eCTD components. To our knowledge, this is the first publicly available R-based FDA submission package, which includes R scripts to generate ADaM datasets and TLFs. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions from different sponsors. Additional agency feedback will be shared in future communications.  For any future questions, you may contact the *pilot 3* team here: <https://rconsortium.github.io/submissions-pilot3-adam/main/index.html>.
+
+See [here](https://www.r-consortium.org/announcement/2023/09/11/first-publicly-available-r-based-submission-package-submitted-to-fda-pilot-3) for more information about pilot 1, 2, 3 and the future plans for pilot 4.