Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study

Abstract

Background: Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. Methods: This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ≥ 80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. Results: From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2-8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n = 134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n = 232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n = 53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. Conclusion: Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.

Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports

“…Despite the widespread endorsement of CTR globally, CTR in FFC remains suboptimal, with no registration or, in many cases, unknown existence of the protocol itself (24%). Our findings are consistent with previous studies that reported protocols were not fully registered [ 16 , 17 , 18 , 19 , 20 , 21 ]. Gopal et al [ 18 ] concluded that unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%, relative risk = 1.38, 95% confidence interval = 1.20–1.58; p = 0.004).…”

“…There are also few registrations in the fields of surgery [ 19 ] and addiction [ 20 ] or for trials in a single country’s health research [ 21 ], which could be because the journal’s regulation did not require registration as a prerequisite for submitting papers. The same might be inferred in the field of nutrition, so journals other than ICMJE member journals are also considered to have an urgent need to register protocols.…”

Repurposed agents in the Alzheimer’s disease drug development pipeline

“…Inaccurate reporting of dual-registered trials on EUCTR is a prevalent issue [ 46 ], which may in part reflect the register’s reliance on sponsors to manually enter study results onto the EudraCT database. Suboptimal completion of RCT protocols and results may lead to overestimates of trial activity [ 47 – 50 ].…”

Sharing of Data from Clinical Research Projects

“…In 2014, The Lancet published the article series "Increasing Value and Reducing Waste" that describes underlying problems and provides possible solutions (3)(4)(5). Even though the first version of the CONSORT statement was published more than 20 years ago, quality of reporting remains suboptimal (6,7). But even if adherence to reporting guidelines would be perfect, essential information often remains unclear for certain aspects (5).…”

“…• Manipulations to decrease precision: Too much precision bears the risk of making entries linkable to persons. Possible methods to decrease precision include relative time in the course of the study instead of precise dates and times 6 , rounding of continuous data, grouping and aggregation (categorization), introducing random noise (jittering, perturbation), setting certain values to missing (suppression), data swapping, resampling or subsampling.…”