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The null hypothesis in clinical studies is that the investigational drug doesnt work. Most of the time it doesnt and patients are better off getting standard o
by aaavl2821 8y ago
The null hypothesis in clinical studies is that the investigational drug doesnt work. Most of the time it doesnt and patients are better off getting standard of care
There are also ethics guidelines that deal with control group selection. If an effective approved drug exists, usually that has to be the control arm, not a placebo. So a patient will get a drug that works in the control arm, though maybe not in the active arm
- nordsieck 8y ago> Most of the time it doesnt and patients are better off getting standard of care The context for "right to try" is a person with a terminal condition that does not respond to any conventional therapies. In essence, the choice is between experimental treatments and hospice. > If an effective approved drug exists, usually that has to be the control arm, not a placebo. There will always be a placebo in a stage 3 trial.
- aaavl2821 8y agoThere is not always a placebo in Phase 3 studies. You can have an active control. Here's an example [0]: active arm is upadacitinib, control is methotrexate (the standard of care) FDA guidelines are you need "at least two adequate and well-controlled studies, each convincing on its own, to establish effectiveness" [1]. Well controlled can be placebo controlled or active control [0]: https://www.prnewswire.com/news-releases/upadacitinib-monotherapy-meets-all-primary-and-ranked-secondary-endpoints-versus-methotrexate-in-a-phase-3-study-in-rheumatoid-arthritis-300659605.html https://www.prnewswire.com/news-releases/upadacitinib-monoth... [1]: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072008.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...