TY - JOUR
T1 - Publication and associated factors of clinical trials registered in Peru
AU - Heredia, Paula
AU - Alarcon-Ruiz, Christoper A.
AU - Roque-Roque, Joel Sack
AU - De La Cruz-Vargas, Jhony A.
AU - Quispe, Antonio M.
N1 - Publisher Copyright:
© 2020 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
KW - biomedical research
KW - clinical trials
KW - Peru
KW - publishing
KW - registries
UR - http://www.scopus.com/inward/record.url?scp=85092139268&partnerID=8YFLogxK
U2 - 10.1111/jebm.12413
DO - 10.1111/jebm.12413
M3 - Artículo
C2 - 33034958
AN - SCOPUS:85092139268
SN - 1756-5383
VL - 13
SP - 284
EP - 291
JO - Journal of Evidence-Based Medicine
JF - Journal of Evidence-Based Medicine
IS - 4
ER -