This event was previously planned on June 11. All participants who signed up for the event on June 11 will automatically be signed up for the new date. If by any chance, this date does not suit, participation may be updated through the form below. All participants will receive a participation link over email in due time.
Presentation slides for this meeting are available per request to: firstname.lastname@example.org
This Spring the BMS-ANed and Pharmaceutical Statistics and Data Management working group (PSDM) jointly organise an online meeting:
Date: 7 July 2020
Time: 15:00 (Central European Summer Time)
Registration is required and is through the form below
Kit Roes – Radboud UMC
Stefan Driessen – Abbott Laboratories
COVID 19 impact on ongoing clinical trials: Regulatory perspective on methodology
The EMA has presented a reflection paper on methodological issues related to the fact that due to the COVID 19 pandemic and associated control measures many clinical trials cannot proceed as planned. This presents an enormous challenge to preserve the value of the trials, end with interpretable data and prevent research waste. The reflection paper is currently being updated as a result of public comments. In the presentation, the fundamentals of the reflection paper will be highlighted, including perspective on comments received and “unknowns” we were not able to address (yet). The role of DMCs, estimands and heterogeneity will be addressed. Where possible, illustration with real examples (albeit somewhat de-identified) will be given of potential issues and countermeasures.
COVID-19 impact on ongoing trials: Industry reaction on statistical issues
The COVID-19 pandemic has had a major impact on ongoing clinical trials. Due to quarantines and lock down, some studies have been halted or interrupted, others have put other measures in place to maintain patient safety and cope with operational issues. These unexpected changes to the conduct of trials also pose challenges to the analysis down stream. Statistical issues come to play in assessing the impact to the ability of still meeting the primary objectives of the trial, such as estimands, missing data, sample size, change of statistical analysis methods, and trial quality. In the presentation the reaction from industry on the questions around these statistical aspects will be given as well as first responses.