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learningcurve2020

05/27/26 11:52 AM

#827846 RE: learningcurve2020 #827819

Deemed unimportant here. LOL. It’s all about future trials and patient level data. No way MHRA gives the ancient Plll a thumbs up, imo. Your one shot to recoup losses is with the CDMO, imo. And that’s not going so well with hardly any business after ten years.

>>When we re-analyzed the data from the INSIGhT trial, we obtained the same result when using our external control datasets as the original randomized trial. This supports the use of external control datasets for future clinical trials.

>>To serve as possible external control arms for GBM trials, we derived patient-level data from multiple real-world and clinical trial datasets, including data from our institution and others. We did this over several years, as it’s very challenging to assemble this type of data.

https://www.massgeneralbrigham.org/en/about/newsroom/articles/external-controls-promising-for-glioblastoma-clinical-trials