Publication and associated factors of clinical trials registered in Peru

Abstract

Objective We aim to determine the percentage of publication and its associated factors of clinical trials (CTs) registered in Peru.

Methods Using a cross-sectional study design, we assessed CTs registered at the CT's Peruvian Registry (REPEC) during the 2011-2016 period, and evaluated its percentage of publication and associated factors. We used a bibliographic search algorithm to determine if the CTs were published and assessed the associated factors by using a Cox regression to estimate the adjusted hazard ratios (aHR) as the magnitude of association of interest.

Results We analyzed 228 CTs, of which 63% were published. The regression analysis identified the year of registration (aHR 2012 = 1.15 [0.58-2.27]; aHR 2013 = 0.45 [0.21-0.95]; aHR 2014 = 0.89 [0.43-1.82]; aHR 2015-2016 = 0.16 [0.05-0.58]), total number of participants (aHR = 1.12; 1.05-1.18), and phase III-IV (aHR = 2.15; 0.1.16-4.03) as factors associated with the publication of the CTs.

Conclusions The percentage of publication of CTs executed in Peru is insufficient, and it increases the older the year of its registration in the REPEC, mayor of the number of participating countries, and if it is a phase III or IV study.