I hate to say it, but this one I agree with RFK Jr on. You have to have a control group. If it’s ethically wrong to not treat with the standard of care then make the placebo group opt-in to placebo so they know they are not getting the current standard of care.
You can still do the compare vs current standard of care, but also need the placebo. Also diseases can evolve so re-comparing to baseline should be a must to make sure the current standard is actually helping like we think it does.