When new drugs are approved, the marketing authorization holders often have to commit themselves to perform additional post-authorization studies. These studies have a different set up. Most countries have adjusted the regulations for studies where the drug is commercially available; although there is no "one fits all" concept.
Synthetic Control Arms: Considerations Around Definition, Drivers, and Design
Those that work in the biopharmaceutical or device industry are likely familiar with the term synthetic controls. But what exactly are synthetic…
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