The hybrid design combines superiority designs for some subgroups and non-inferiority designs for other groups in one trial.
Design: A superiority randomized double-blinded controlled trial from 2006 to 2010 in both medical and surgical ICUs.
16 Finally, the decision to design a superiority instead of an equivalence trial placed MMF in a more challenging position.
In this paper, the authors propose hybrid designs which may combine a superiority design in one subgroup with a non-inferiority design in another subgroup or combine designs with different control regimens in different subgroups in one trial when a uniform design is unethical or impractical.
Because BIG 1-98 was designed as superiority trial, a lack of difference between groups cannot be inferred as equivalence between treatments.
When treatments are equally effective regarding the primary endpoint and it is not clearly stated whether a trial was designed as superiority or non-inferiority trial, results should be classified as positive.
Because we did not have sufficient toxicity information regarding LDPF-RT at the time this study was planned, we prepared a phase II component within the phase III trial to determine whether the phase III trial would be designed as superiority or a non-inferiority trial (based on the relative toxicities of the two arms).
These designs could be superiority, non-inferiority designs, or historical controlled designs.
This study is a six-week, two-arm, parallel, randomized controlled trial (two weeks baseline and four weeks intervention; Figure 2) with a superiority design.
As the clinical study is based on a superiority design (it is hypothesized that nifedipine decreases preterm birth), the proper economic evaluation design is a cost-effectiveness analysis (CEA): the optimal strategy will probably be dominant, i.e. better health outcomes and lower costs.
These trials used superiority design aiming to address the question if one treatment is superior to another.
