To cover for the possible adverse effects
Insurance policies often don't cover you while you're enrolled in a trial ("you wouldn't have broken your leg if you hadn't been in that cholesterol drug trial so we don't cover that").
The agency really cares a lot, especially about SAEs, and if someone is hit by a trolley while in a cholesterol drug study they will want the company to promptly determine that the drug didn't cause them to stumble, or lose vision, or be confused about where they were. We used to joke at one company, "but being hit by a meteor is not an SAE."
> We put the patient in the driver’s seat before, during, and after a trial. Because it’s not just doctors who help build a healthier future. It’s patients. And it’s time to do right by them.
It sounds like they're saying, "patients are treated very badly and we're here to fix that problem". How bad is it to be in a drug trial currently? Are trial participants really treated with neglect? I don't understand what actual problem they're addressing.