Registry data on the use of biologics give important additional information on how the drug is behaving in daily practice.
As Prof. Bruce E. Strober (UConn Health, USA) pointed out, randomised controlled clinical trials (RCT) lasting up to 1 year now exist for all biologics and present the “gold standard” of evidence-based medicine . However, they have several important limitations: they allow no long-term (>1 year) comparative efficacy assessments; milder patients are often excluded as only more severe patients are enrolled; and due to strict inclusion criteria, patients are generally healthier than in daily practice and have fewer comorbidities. No combination therapy is evaluated in these trials, even though combinations are very common in daily practice.
“To get a thorough picture of a drug, registries are required to establish comparative long-term effectiveness,” said Prof. Strober. They allow longer term cross comparisons, often beyond ...
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