
StataCorp will be a sponsor and exhibitor at the SCT 2023 Annual Meeting. Attending from StataCorp: Chuck Huber, Director of Statistical Outreach, and Yulia Marchenko, Vice President, Statistics and Data Science. We're also hosting an in-conference workshop. For more information about the meeting, visit the SCT 2023 Annual Meeting page.
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Title: | Reproducibility and automated reporting in clinical trials |
Presenters: |
Chuck Huber, Director of Statistical Outreach Yulia Marchenko, Vice President, Statistics and Data Science |
Date: | Monday, 22 May 2023 |
Time: | 12:45–2:15 p.m. ET |
Abstract: | Reproducibility of clinical trials (and scientific studies in general) has been gaining increasing attention in recent years. But what exactly is reproducibility in the context of clinical trials? How is it related to replication, repetition, and automation? When can we achieve reproducibility and to what degree? How can we incorporate reproducibility in our data analyses? And how can we produce reproducible reports such as DMC reports? We will answer these questions and more in this workshop. Finally, as an example of reproducible analyses and reporting of the results, we will go over the steps of creating an abridged version of a DMC report, following the most recent guidelines. The demonstration will use Stata, but the concepts and methodologies can be applied to other software of choice. (Temporary Stata licenses will be provided to workshop participants so that they can reproduce analyses both during and after the workshop.) |
Goals: | The goal of this workshop is to define and discuss the concepts of reproducibility, replication, and automation in the context of data analysis and reporting in clinical trials. The examples will focus on the content and style of DMC reports and how to automate their creation while keeping in mind reproducibility. We will review the recent recommendations for best practices for DMC reports, including the content and style of tables and graphs. Then we will demonstrate how to automate the creation of these reports using Stata, but the presented advice and methodology can be adapted to other software as well. We will include details such as FDA software installation verification, integrated version control, extraction of data from secure databases, checking data integrity, reproducible data analysis, and the creation of tables, graphs, and final DMC reports. |
Fee: | $50.00 |
Chuck Huber is Director of Statistical Outreach at StataCorp and Adjunct Associate Professor of Biostatistics at the Texas A&M School of Public Health and at the New York University School of Global Public Health. In addition to working with Stata's team of software developers, he produces instructional videos for the Stata YouTube channel, writes blog entries, develops online NetCourses, and gives talks about Stata at conferences and universities. Most of his current work is focused on statistical methods used by behavioral and health scientists. He has published in the areas of neurology, human and animal genetics, alcohol and drug abuse prevention, nutrition, and birth defects. Dr. Huber currently teaches survey sampling at NYU and introductory biostatistics at Texas A&M, where he previously taught categorical data analysis, survey data analysis, and statistical genetics.
Yulia Marchenko is Vice President, Statistics and Data Science at StataCorp. Yulia has been with Stata for over 15 years and has more than 20 years of software development experience. Her primary responsibility is to oversee Stata's scientific software development. Her areas of interest include Bayesian analysis, multiple imputation, meta-analysis, multilevel modeling, survival analysis, power analysis, causal analysis, and other areas of statistics, biostatistics, and econometrics. Yulia has a PhD in statistics from Texas A&M University.
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