This should be the second of two Phase III studies, which are pretty rigorous. Some drugs are just very hard to make a valid control for.
Some studies also use a drug placebo and a control group with a combination of interventions, or little to none at all, as best as I understand.
One can use statistics afterwards to help bolster claims of efficacy if a sham/placebo group is difficult to source.
This is my best understanding of the matter.
This should be the second of two Phase III studies, which are pretty rigorous. Some drugs are just very hard to make a valid control for.
Some studies also use a drug placebo and a control group with a combination of interventions, or little to none at all, as best as I understand.
One can use statistics afterwards to help bolster claims of efficacy if a sham/placebo group is difficult to source.
This is my best understanding of the matter.