title: Are clinical trial results transferable in the real life?
abstract: Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than post-hoc analyses.
authors.affiliation: S. Camillo Forlanini. natale.enrico@tiscali.it.
authors.forename: Enrico
authors.initials: E
authors.lastname: Natale
authors.forename: Alfiera
authors.initials: A
authors.lastname: Marsocci
mesh_terms: D006801:Humans; D064887:Observational Studies as Topic; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D016896:Treatment Outcome