One way to ensure that results are valid is to prove that the active comparator is superior compared to a placebo. This could require a separate trial (which, again, could lead to ethical problems).
Brief Summary: This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe...
This phase 3, multicenter, double-blind, parallel-group, randomized, placebo- and active-comparator-controlled trial from Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO2) was conducted from May 2016 through November 2019...
...controlled trials published between 1 January 1996 and 24 November 2021 that examined the effect of bisphosphonates, denosumab, selective oestrogen receptor modulators, parathyroid hormone receptor agonists, and romosozumab compared with placebo or active comparator.
Introduction: Non-inferiority trials (NI) test the efficacy of an experimental treatment in comparison to an active-controlled treatment and indirectly with the historical placebo to demonstrate that the new treatment is no worse than the active comparator.
Data synthesis: A MEDLINE database search was performed to identify all RCTs, up to June 1st, 2021, with duration52 weeks, in which insulin was compared with either placebo or active comparators.
The ICMRA noted that phase 3 clinical trials should be randomized, double-blinded and controlled with a placebo or active comparators.
