Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals

Abstract

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015

“…In 2013, the registration rate of randomized controlled trials was only 19.8% (13), but our study, which followed a similar methodology, found an overall registration rate of 59.9% in 2015. Moreover, among all registered trials, the rate of prospective registration increased from 6.9% to 48.3% in 2013–2015 (14 – 16). This increase, over a relatively short time period, is a promising trend that may represent the increasing concern for the quality and transparency of clinical trials in LAC countries.…”

“…While adherence to trial registration has increased in recent years, it is still difficult to get an accurate measurement. Some studies have been monitoring the prevalence of trial registration among published studies (14).…”

Identification of biomedical journals in Spain and Latin America

“…In addition, 12.3% of the identified journals do not meet the minimal criteria required of academic journals: even though they are indeed periodical journals that publish some original research, they do not have an ISSN number, which is an internationally accepted code for identifying periodical publications . Another study recently published determined that just 19.8% of a sample of 101 trials published in 2011 in 56 Latin American journals mentioned trial registration . Of these journals, only 68% endorsed guidelines from the International Committee of Medical Journals Editors, and 36% required trial registration.…”

Lack of transparency in clinical trials: a call for action

“…The Consolidated Standards for Reporting Clinical Trials (CONSORT) were published in 2001 with the intention to improve the quality of reporting clinical trials in medical journals. A large number of interventional studies published in indexed medical journals do not comply with these guidelines 2,3 . Nowadays, these requirements are absent in a considerable number of peerreview medical journals around the world.…”

“…Only one out of five published clinical trials by Latin American and Caribbean journals reported a registration number. Author's information about CONSORT is currently provided only by 13% of these medical journals 2 . The Latin-American Ongoing Clinical Trials Registry (LATINREC) is not operating despite the efforts of many people involved in their creation and promotion 5 .…”