Janick Weberpals

Sep 17, 2024 | ascpt.onlinelibrary.wiley.com | Janick Weberpals |Shirley Wang

Regulators increasingly rely on real-world evidence generated from routine-care health data to evaluate novel therapies. Particularly, external control arms are increasingly used to supplement and contextualize efficacy and safety claims of single arm clinical trials for rare disease therapies. However, there are a number of methodological issues that may affect the validity of results derived from such comparisons.

Jan 3, 2024 | onlinelibrary.wiley.com | Janick Weberpals |Shirley Wang |Selby JV

CONFLICT OF INTEREST STATEMENT The authors declare no conflict of interest. Supporting Information Filename Description pds5740-sup-0001-Supinfo.pdfPDF document, 513.4 KB Data S1. Supporting Information: Supplementary Appendix and Figures (pdf ). REFERENCES 1 United States Food and Drug Administration. Framework for FDA's real world evidence program. 2018.

Aug 19, 2023 | dovepress.com | Janick Weberpals |Sudha R. Raman |Pamela A. Shaw |Hana Lee

Back to Journals » Clinical Epidemiology » Volume 16 Authors Weberpals J , Raman SR, Shaw PA, Lee H, Russo M, Hammill BG, Toh S , Connolly JG, Dandreo KJ , Tian F, Liu W, Li J, Hernández-Muñoz JJ , Glynn RJ, Desai RJ Received 19 August 2023 Accepted for publication 9 April 2024 Published 21 May 2024 Volume 2024:16 Pages 329—343 DOI https://doi.org/10.2147/CLEP.S436131 Checked for plagiarism Yes Review by Single anonymous peer review Peer reviewer comments 4 Editor who approved publication:...