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| Title | BERD Facilitates Unique and Successful Collaboration between the FDA, Industry, and CTSA |
| Year | NA |
| Contributor/Contact | Mat Soukup (FDA), Mary Banach, Frank Harrell |
| CTSA | UC Davis, Vanderbilt |
| Success Topic | Collaboration |
| Description of Success |
Monitoring clinical trials for the safety of patients enrolled is a key component of RCTs. Unlike efficacy parameters, safety parameters are large in number and have a wide focus. Detection of safety signals by DSMBs and by biostatisticians is not easy when reviewing a myriad of data elements. Graphical presentation of safety data has been shown to be of major benefit to DSMB members and to pharmaceutical companies. To work on these important questions and develop a systematic approach to identifying best practices the Clinical Trials Safety Graphics Working Group was formed with the CDER branch of the FDA (George Rochester, Mat Soukup, and Rich Forshee). industry (representing Merck, Eli Lilly, Johnson & Johnson, Pfizer, Novartis, GlaxoSmithKline, Bayer, Roche, and others), and CTSA Biostatisics, Epidemiology, and Research Design (BERD) members (Frank Harrell - Vanderbilt; Mary Banach – UC Davis), using the CTSpedia platform. The Clinical Trials Safety Graphics Working Group is composed of four sub-groups: three discussing and identifying best graphical presentations of Adverse Event, Labs and Liver, and ECG/Vitals safety questions; and a fourth general principles sub-group looking at best practices in statistical graphics and data visualizations. Currently, the groups have uploaded 65 graphs with images, background information, answers to clinical questions, references, and code. The information is organized for the user to easily navigate between type of graph, clinical questions, images, and contributor information. Due to the collaborative nature of the wiki, users are encouraged to provide feedback and additional code for the graphical entries. This is a totally volunteer effort and is successful because all group members share a commitment to the final product. Using a wiki, all members can suggest clearer ways to present the information and new formats can be tested as the graphics are developed. One of the reasons for the success of the collaboration is that no proprietary information is provided on the site; but rather that ideas and best practices are discussed, tested, and revised. For more information, go to: Clinical Trials Safety Graphics Home Page. |
| Description Image | |
| Open to Public | Yes |
| BERD Watch | Yes |
| BERD Watch Suggestions | |
| Published_BERD_Watch | BERD Facilitates Collaboration among the FDA, Industry and CTSAs |
| Additional Information | |
| Disclaimer | The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated. |
Topic revision: r7 - 21 Jun 2012 - 13:26:24 - MaryBanach
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