A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols.
J Clin Epidemiol
; 149: 45-52, 2022 09.
Article
em En
| MEDLINE
| ID: mdl-35654268
ABSTRACT
OBJECTIVES:
Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency. STUDY DESIGN ANDSETTING:
In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.RESULTS:
Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (>500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.CONCLUSION:
RCT protocols should be made available at an early stage of the trial.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pesquisadores
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Prognostic_studies
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
J Clin Epidemiol
Assunto da revista:
EPIDEMIOLOGIA
Ano de publicação:
2022
Tipo de documento:
Article