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Posted On: 07/10/2019 11:55:34 AM
Post# of 72443
FDA looking at major changes in clinical trial design and approval. The article below goes into some good detail -- but an important takeaway is that they are looking more at PATIENT-centered outcomes -- looking at potentially small improvements that are meaningful to patients with bad diseases, and also looking at letting patients have the drug (not the placebo) when there is a lot of evidence about the outcomes without the drug. That would make it a lot easier to recruit patients for clinical trials, if they know they're going to get the drug, and it's also a lot more humane, when you've got people who are very sick, to let EVERYONE have a chance at a longer and/or better life.
https://endpts.com/the-fdas-janet-woodcock-ta...y-reviews/
https://endpts.com/the-fdas-janet-woodcock-ta...y-reviews/
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