|
1 | 1 | --- |
2 | 2 | engine: knitr |
3 | 3 | title: "Demographic Table" |
| 4 | +execute: |
| 5 | + echo: false |
4 | 6 | --- |
5 | 7 |
|
6 | | -# Learning objectives |
7 | 8 |
|
8 | | -::: nonincremental |
9 | | -- THESE ARE NICE TO HAVE BUT NOT ABSOLUTELY NECESSARY |
10 | | -::: |
| 9 | +# Introduction |
| 10 | + |
| 11 | +## SDTM |
| 12 | + |
| 13 | +- SDTM: a standard for organizing and formatting "raw" data (e.g from paper diaries, or e-diaries) |
| 14 | + |
| 15 | +- Defines **standard domains** |
| 16 | + |
| 17 | +- Relies on **standardized** variable names, metadata, and controlled terminology |
| 18 | + |
| 19 | +- Supports the submission of data to regulatory authorities |
| 20 | + |
| 21 | +Created with help of CDISC genius. |
| 22 | + |
| 23 | +## ADAM |
| 24 | + |
| 25 | +- ADaM: provides a standard framework for derivations for statistical analyses. |
| 26 | + |
| 27 | +- Promoting: transparency, reproducibility, and regulatory compliance. |
| 28 | + |
| 29 | +- **Traceability**: Clear linkage from analysis results back to source data (often SDTM). |
| 30 | + |
| 31 | +- **Standard structures**: Like ADSL (Subject-Level Analysis Dataset), BDS (Basic Data Structure), and OCCDS (Occurrence Data Structure). |
| 32 | + |
| 33 | +- **Derived variables**: Emphasis on clarity and documentation of derived data used in analysis. |
| 34 | + |
| 35 | +Created with help of CDISC genius. |
| 36 | + |
| 37 | +## ADAM |
| 38 | + |
| 39 | +- **Integration with Define-XML**: |
| 40 | + |
| 41 | +- Enables metadata-driven submissions to regulatory agencies |
| 42 | + |
| 43 | +- Explains derivation of variables |
| 44 | + |
| 45 | +- Enables re-creation of derivations & statistical analyses by regulatory authorities |
| 46 | + |
| 47 | +Created with help of CDISC genius. |
| 48 | + |
| 49 | +# Tables, Listings and Graphs/Figures (TLGs/TLFs) |
| 50 | + |
| 51 | +TLFs: Static output generation for Clinical Study Report |
| 52 | + |
| 53 | +- Listings: One proc away (filtering , subsetting etc. ), lay-out |
| 54 | +- Tables/ Figures: pre-processing, calculate summary statistics, lay-out (e.g.bars/lines/scatter/ presentation summary statistics) + formatting (e.g titles and footnotes) + export output (e.g. pdf, rtf & html) |
| 55 | + |
| 56 | +Created with help of CDISC genius. |
| 57 | + |
| 58 | +## TLGs |
| 59 | + |
| 60 | +Static outputs are part of the clinical reporting process. They are a vital part to summarise the results of the clinical trial. They can summarise safety, efficacy and exploratory outcomes, e.g. biomarkers, QOL, questionnares etc. |
| 61 | + |
| 62 | +Safety outputs (medical history, adverse events, and concomitant medications) are pretty much similar and standard outputs that you will see across all clinical trials ( regardless of sponsor/therapeutic area). |
| 63 | + |
| 64 | +Note. These domain names come from SDTM. |
| 65 | + |
| 66 | +## TLGs workflow |
| 67 | + |
| 68 | +```{r} |
| 69 | +#install.packages("DiagrammeR") |
| 70 | +library(DiagrammeR) |
| 71 | +mermaid(" |
| 72 | +graph TD |
| 73 | + A[SAP/Protocol] --> B[MOCK TFLs] |
| 74 | + B --> C[ADAM] |
| 75 | + C --> D[TFLs] |
| 76 | +") |
| 77 | +``` |
11 | 78 |
|
12 | 79 | ::: notes |
13 | | -- You can add notes on each slide with blocks like this! |
14 | | -- Load a deck in the browser and type "s" to see these notes. |
| 80 | +ProtocoL: Defines parameters to be analysed SAP: Defines how analyses to be conducted ADAM: Contains all variables and metadata that is required for the production of all outputs TLG: Present analysis results |
15 | 81 | ::: |
16 | 82 |
|
17 | | -# SLIDE SECTION |
| 83 | +## TLGs Catalogs |
| 84 | + |
| 85 | +Catalogs with many examples are available here: |
| 86 | + |
| 87 | +- [TLG Catalog](https://insightsengineering.github.io/tlg-catalog/stable/) |
| 88 | +- [Biomarker Catalog](https://insightsengineering.github.io/biomarker-catalog/stable/tables/) |
| 89 | +- [Teal Gallery](https://insightsengineering.github.io/teal.gallery/) |
| 90 | + |
| 91 | +# Demographic Table |
| 92 | + |
| 93 | +[DMT01](https://insightsengineering.github.io/tlg-catalog/stable/tables/demography/dmt01.html) |
| 94 | + |
| 95 | +## Method 1 |
| 96 | + |
| 97 | +- The {cards} package creates Analysis Results Datasets (ARDs, which are a part of the CDISC Analysis Results Standard). |
| 98 | +- The {gtsummary} utilizes ARDs to create tables. |
| 99 | + |
| 100 | +## Method 2 |
| 101 | + |
| 102 | +- NEST Package: A collection of open-sourced R packages: |
| 103 | + |
| 104 | + - {rtables}: Foundational layer of the table creation - can create simple to complex table lay outs via nested splitting - in row- and column - space and the specification of analysis functions which will calculate cell values. |
| 105 | + |
| 106 | + - Customize tables by defining how to split data into rows and columns, and what calculations to perform in each cell. |
| 107 | + |
| 108 | + - Provide a framework to create, tabulate and render. |
| 109 | + |
| 110 | + - Provides a variety of options for table customization. |
| 111 | + |
| 112 | + - {rlistings}: create listings |
| 113 | + |
| 114 | + - {tern}: Layers analytics from descriptive summaries to more complex statistics on top of the foundational table layouts, analytic and content controls. |
| 115 | + |
| 116 | + - Act as wrapper around {rtables} / Reporting layer that sits on top of rtables. |
| 117 | + |
| 118 | + - Contains analytical functions for creating tables and graphs. |
| 119 | + |
| 120 | + - Functionalities included: data visualization functions, statistical modelling, analyze functions amongst others. |
| 121 | + |
| 122 | + - {formatters} |
| 123 | + |
| 124 | + - {teal} |
| 125 | + |
| 126 | +- Other Package: |
| 127 | + |
| 128 | + - GGPLOT2 |
18 | 129 |
|
19 | | -## SLIDE |
| 130 | +## {rtables} |
20 | 131 |
|
21 | | -- DENOTE MAJOR SECTIONS WITH `# TITLE` (eg `# Installation`) |
22 | | -- ADD INDIVIDUAL SLIDES WITH `##` (eg `## rustup on Linux/macOS`) |
23 | | -- KEEP THEM RELATIVELY SLIDE-LIKE; THESE ARE NOTES, NOT THE BOOK ITSELF. |
| 132 | ++-------------------+--------------------+ |
| 133 | +| | {rtables} function | |
| 134 | ++===================+====================+ |
| 135 | +| Demographic table | basic_table() | |
| 136 | ++-------------------+--------------------+ |
| 137 | +| | split_cols_by() | |
| 138 | ++-------------------+--------------------+ |
| 139 | +| | add_overall_col() | |
| 140 | ++-------------------+--------------------+ |
| 141 | +| | show_col_counts() | |
| 142 | ++-------------------+--------------------+ |
| 143 | +| | build_table() | |
| 144 | ++-------------------+--------------------+ |
| 145 | +| | export_as_rtf()/ | |
| 146 | +| | | |
| 147 | +| | export_as_pdf() | |
| 148 | ++-------------------+--------------------+ |
24 | 149 |
|
25 | | -## SLIDE |
| 150 | +## {Tern} |
26 | 151 |
|
27 | | -# SLIDE SECTION |
| 152 | ++-------------------+------------------------------+ |
| 153 | +| | {tern} analyze function | |
| 154 | ++===================+==============================+ |
| 155 | +| Demographic table | analyze_vars() | |
| 156 | +| | | |
| 157 | +| | ( before: summarize_vars() ) | |
| 158 | ++-------------------+------------------------------+ |
28 | 159 |
|
29 | | -## SLIDE |
| 160 | +## Analyze functions |
30 | 161 |
|
31 | | -## SLIDE |
| 162 | +- .stats: which statistics to be displayed in the ta |
| 163 | +- .formats: which value formats should be u |
| 164 | +- .labels: which row labels should be used |
| 165 | +- .indent_mods: indent modifiers for the labels |
| 166 | +- .show_labels: whether variable label(s) should be visible or hidden |
0 commit comments