PubMed · 7904085
Protocol development for combination therapy with disease-modifying antirheumatic drugs.
Abstract
To date, it has been exceptionally difficult to prove that any combination of disease-modifying antirheumatic drugs is more effective than its components used one at a time. However, only a few of many possible combinations have been evaluated in clinical trials. Careful attention to the details of patient selection, study design and duration, and choice of primary outcome measures is essential. A logical strategy for protocol development emphasizes the use of multiple small pilot studies to screen series of combinations and doses to identify a few that appear to show clinical benefit. The most promising combinations can then be evaluated in large, double-blind, randomized, pivotal studies with a higher probability of success.
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H E Paulus. 1993. Protocol development for combination therapy with disease-modifying antirheumatic drugs.. https://doi.org/10.1016/s0049-0172(10)80004-6
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