I used to be more certain of things. The Chicago Cubs would never win a World Series. If you do not conduct a head to head superiority trial versus active comparator, a pharmaceutical company would not achieve commercial success.
Maybe I was right about the Cubs, but I now believe there are certain disease states where a head to head superiority trial versus active comparator is not necessary. Superiority to placebo can be commercially relevant when the indication you are seeking has a high level of patient heterogeneity and a paucity of drugs. For example, in Systemic Lupus Erythematous (SLE) a placebo controlled registration trial can yield payer relevant evidence by providing a new treatment option for patients and prescribers.
This may not be the Cubs year (once again), however rigid adherence requiring a head to head registration trial versus active comparator may not apply in every therapeutic area.
