Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

Scott, Allan; Rucklidge, Julia J.; Mulder, Roger

doi:10.1371/journal.pone.0133718

Cited by 95 publications

(86 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although no direct mechanism exists for identifying unregistered trials systematically, late registrations are a marker that stakeholders enable trials to proceed without prospective registration. 19,24 …”

Section: Assessing Clinicaltrialsgov and The Evolving Trsmentioning

confidence: 99%

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

et al. 2017

View full text Add to dashboard Cite

In the decade following the journal editors’ trial registration policy, a global trial reporting system (TRS) has arisen to supplement journal publication by increasing the transparency and accountability of the clinical research enterprise (CRE), which ultimately advances evidence-based medicine. Trial registration a foundation component of the TRS. In this article, we assess impact of the trial registration on the CRE with respect to two key goals: (1) establishing a publicly accessible and structured public record of all trials and (2) ensuring access to date-stamped protocol details that change during a study. After characterizing international trial registry landscape, we summarize the published evidence of the impact of the registration laws and policies on the CRE to date. We present three analyses using ClinicalTrials.gov registration data to illustrate approaches for assessing and monitoring the TRS: (1) timing of registration (i.e., prior to trial initiation [prospective] or after trial initiation [retrospective or “late”]; (2) degree of specificity and consistency of registered primary outcome measures compared to descriptions in study protocols and published articles; and (3) a survey of the published literature to characterize how ClinicalTrials.gov data has been used in research on the CRE. These findings suggest that, while the TRS is largely moving towards goals, key stakeholders need to do more in the next decade.

show abstract

Section: Assessing Clinicaltrialsgov and The Evolving Trsmentioning

confidence: 99%

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

et al. 2017

View full text Add to dashboard Cite

show abstract

“…In a review of five psychiatry journals that mandate registering of prospective clinical trials, it was reported that only 33% of trials were correctly prospectively registered and, of these, 28% had evidence of selective outcome reporting and 27% a large change in participant numbers. Overall, only 14.4% were correctly registered and reported 7. For psychotherapy RCTs, the results were even worse.…”

Section: ‘It-work-somewhere’mentioning

confidence: 92%

The limitations of using randomised controlled trials as a basis for developing treatment guidelines

Mulder

Singh

Hamilton³

et al. 2017

Evid Based Mental Health

View full text Add to dashboard Cite

Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality.

show abstract

“…As noted below, a system of prospective registration of clinical trials is in place to combat this issue. However, data suggest that the toptier psychiatric journals still allow changes in registered primary outcomes without this being highlighted in the paper (Scott et al, 2015). Outside the area of randomised control trials, there is little in place to avoid this problem.…”

Section: Other Ways In Which Negative Findings Are Minimisedmentioning

confidence: 99%

Failure to publish negative results: A systematic bias in psychiatric literature

Porter

Boden

Miskowiak

et al. 2016

Aust N Z J Psychiatry

View full text Add to dashboard Cite

Reprints and permissions: sagepub.co.uk/journalsPermissions.nav journals.sagepub.com/home/anp This month's edition of ANZJP publishes an important negative study. Dean et al. (2016) report on the effects of N-acetylcysteine in children with autistic spectrum disorder. The trial was prospectively registered in 2010, the last participant was enrolled in 2013, there was a 6-month followup and the trial was published online in June 2016. Notable also is that the primary outcome measures are exactly as stated in the registration. This represents relatively rapid publication of important negative data, in line with the appropriate transparent processes, for which the authors are to be commended. However, such rigorous and rapid publication of negative results is relatively rare, and this represents an important problem in psychiatric literature.

show abstract

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

Cited by 95 publications

References 27 publications

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

The limitations of using randomised controlled trials as a basis for developing treatment guidelines

Failure to publish negative results: A systematic bias in psychiatric literature

Contact Info

Product

Resources

About