Thursday, January 11, 2024

Tables, Listings and Figures

What is Tables, Listings and Figures?

TLFs (Tables, Listings, and Figures) are outputs that are generated from clinical trial data to summarize the results of the study. TLFs are a critical component of the clinical trial reporting process, as they provide a clear and concise summary of the trial results for regulatory submissions and publications.

Tables are typically used to summarize the key findings of the study, including demographic data, efficacy, and safety results. Listings provide a detailed view of the data, often organized by subject or by treatment group. Figures, on the other hand, are used to visually represent the data and may include graphs, charts, or other visualizations.

It involves a number of steps, including data cleaning and processing, statistical analysis, and the generation of the actual tables, listings, and figures. SAS is a widely used software in clinical trials for data management and statistical analysis, and it provides tools for creating TLFs that are compliant with industry standards and regulatory requirements.

Different Types of TLFs Used in Clinical SAS

  • Summary tables: These tables provide a summary of the key findings of the study, including demographics, baseline characteristics, efficacy, and safety results.
  • Adverse event listings: These listings provide a detailed view of the adverse events that occurred during the study, including the severity and frequency of the events.
  • Laboratory data listings: These listings provide a detailed view of the laboratory data collected during the study, including the results of blood tests, urine tests, and other laboratory analyses.
  • Efficacy plots: These figures provide a visual representation of the efficacy results, such as Kaplan-Meier curves, forest plots, or scatter plots.
  • Safety plots: These figures provide a visual representation of the safety results, such as bar charts, pie charts, or stacked bar charts.
  • Demographic tables: These tables provide a summary of the demographics of the study population, including age, gender, race, and ethnicity.
  • Subject disposition tables: These tables provide a summary of the number of subjects who completed the study, dropped out, or were withdrawn for other reasons.
  • Protocol deviations tables: These tables provide a summary of any protocol deviations that occurred during the study.

The specific types of TLFs used in a clinical trial will depend on the study design, the data collected, and the regulatory requirements for the trial.

Listings in TLFS

Listings are an important component of Tables, Listings, and Figures (TLFs) in Clinical SAS. Listings provide a detailed view of the data collected in a clinical trial and can be used to supplement the summary information presented in tables and figures. Some common types of listings used in clinical SAS TLFs include:

  • Adverse event listings: These listings provide a detailed view of the adverse events that occurred during the study, including the severity and frequency of the events.
  • Laboratory data listings: These listings provide a detailed view of the laboratory data collected during the study, including the results of blood tests, urine tests, and other laboratory analyses.
  • Demographic listings: These listings provide a detailed view of the demographic data collected during the study, including age, gender, race, and ethnicity.
  • Medical history listings: These listings provide a detailed view of the medical history data collected during the study, including pre-existing conditions and concomitant medications.
  • Concomitant medication listings: These listings provide a detailed view of the medications taken by subjects during the study, including the frequency and duration of use.
  • Vital sign listings: These listings provide a detailed view of the vital signs data collected during the study, including blood pressure, heart rate, and temperature.

Listings can be presented in various formats, such as a table or a listing report. The data in listings can also be filtered and sorted to provide a customized view of the data for specific analysis needs. In Clinical SAS, listings can be generated using SAS procedures such as PROC PRINT or PROC REPORT and can be customized to meet the specific needs of the study.

Difference between Tables and Listings

  • Summary vs. detailed information: Tables typically provide a summary of the key findings of the study, while listings provide a more detailed view of the data. Tables may include summary statistics, such as means or proportions, while listings provide individual data points.
  • Format: Tables are typically presented in a tabular format, while listings may be presented as a list of data points or in a report format.
  • Purpose: Tables are often used to present key findings in a concise and easy-to-read format, while listings are used to provide a more detailed view of the data for further analysis.
  • Regulatory requirements: Both tables and listings are important for regulatory submissions, but the specific requirements for each may differ. For example, regulatory authorities may require certain types of tables for efficacy or safety data, while listings may be required to provide detailed information on adverse events.
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