Non-Inferiority Trials, Please, US FDA Implores Rheumatoid Arthritis Sponsors

RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.

Arthritic hands
The US FDA would like to see non-inferiority trial designs in rheumatoid arthritis drug development. • Source: Shutterstock

The US Food and Drug Administration continues to promote the use of active-controlled, non-inferiority trial designs in rheumatoid arthritis, but sponsor uptake has not been enthusiastic, speakers indicated at a recent virtual summit sponsored by the FDA and the American College of Rheumatology.

Rheumatoid arthritis was one of the first indications to benefit from the evolution of the immunology pharmacopoeia from disease-modifying antirheumatic drug warhorses to include new mechanisms in both small molecules...

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