-
Views
-
Cite
Cite
Z.Z.N. Yiu, Disease‐specific treatment registries for research: psoriasis as an exemplar, British Journal of Dermatology, Volume 176, Issue 3, 1 March 2017, Pages 794–796, https://doi.org/10.1111/bjd.15291
Close - Share Icon Share
Extract
The quality of evidence for the efficacy and safety of psoriasis treatments is variable. There are few high‐quality randomized clinical trials (RCTs) investigating nonbiologic therapies. RCTs of biologic therapies for the treatment of psoriasis often have a short double‐blinded placebo/comparator‐controlled period and lack the adequate sample size to investigate rare adverse events. In addition, patients who are excluded from RCTs have a higher risk of serious adverse events.1 Observational studies, in particular those using patient registries, provide real‐world evidence where RCTs cannot.2
RCTs are often funded by one pharmaceutical company that is interested in demonstrating the superiority of their own drug and RCTs relating to biological therapies for psoriasis evaluate at most three different drugs (usually the drug of interest, a comparator drug and/or placebo). Furthermore, RCTs have a variety of exclusion criteria, which can reduce the generalizability of the results.
By contrast, observational studies utilize large routinely collected datasets or registries, where data has been collected over many years, to perform comparisons across many treatments, allowing for inferences to be made regarding the effectiveness and safety of multiple treatments. Observational studies are useful in the evaluation of nonbiologic psoriasis therapies, most of which are of little interest to the pharmaceutical industry. They are also valuable for testing clinical equivalence and comparative effectiveness/safety of biosimilars. Observational data minimizes the risk of a ‘Hawthorne’ or ‘trial’ effect and can be used to evaluate other aspects of real‐world drug utilization, such as drug adherence, prevalence of treatment switches and dosing patterns. Observational data can also be used to inform organizations involved with healthcare resource planning.
