Ensayos clínicos de baja intervención en España: ¿progresan?

Low-Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non-commercial clinical trials (NCCTs); the mandatory implementation of CTIS in 2023 may have impacted LICTs feasibility. Our aim was to describe the main characteristics of LICTs approved in Spain over a ten-year period.

Cross-sectional descriptive analysis of LICTs registered between 2014 and 2023, in the Spanish Clinical Studies Registry (REec) database, mandatory to all authorized trials.

Between January 2014 and December 2023, 8497 clinical trials were registered in REec, of which only 3.8% (N = 322) were classified as LICTs. No drop in the overall proportion of LICTs was seen in 2023. Most LICTs were sponsored by non-commercial entities and funded primarily through sponsors' own resources. LICTs were frequently monocentric phase IV studies evaluating commercialized medicinal products. The principal objectives of the trials included efficacy and/or safety, while pharmacoeconomics, pharmacogenetics, pharmacogenomics and bioequivalence were comparatively infrequent as main objectives. Most trial designs were randomized, but blinded trials were less frequent, and only a minority were placebo-controlled.

Despite their critical role in establishing effectiveness and safety of authorized medicinal products in pragmatic clinical settings, LICTs still constitute a relatively small proportion of all clinical trials approved in Spain, and their designs have area for improvement in terms of robustness. There was no apparent effect of CTIS implementation on LICTs activity.