From registration to publication: A study on Dutch academic randomized controlled trials

Huiskens, Joost; Kool, Boudewijn R. J.; Bakker, Jean-Michel; Bruns, Emma R J; Jonge, Stijn De; Olthof, Pim B.; Rosmalen, Belle V. van; Gulik, Thomas M. van; Hooft, Lotty; Punt, Cornelis J.A.

doi:10.1002/jrsm.1379

Cited by 6 publications

(9 citation statements)

References 28 publications

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“…Compared to previous research, in our project a high proportion of trials (83%) were published. Systematic reviews and retrospective research projects investigating the publication proportion of RCTs resulted in considerably lower proportions of 60 to 71% [ 4 , 35 – 37 ]. Only 37% of RCTs presented as conference abstracts were published in full as journal articles [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Blümle

Wollmann

Bischoff

et al. 2021

BMC Med Res Methodol

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Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

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Section: Discussionmentioning

confidence: 99%

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Blümle

Wollmann

Bischoff

et al. 2021

BMC Med Res Methodol

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“…Upcoming studies could conduct a survey, asking researchers for the reasons they had to change the start dates, or more broadly, other critical details of the registered study protocol. Studies that have dealt with changes within the registry, or between registry entries and publications (16)(17)(18)(19)(20)(21)(22), have to our knowledge not yet surveyed the authors. While we only considered the case of potential questionable research practices that concern changes to a clinical trial's start date, similar potential issues exist, as other elements of a trial's registration can also be changed retroactively.…”

Section: Discussionmentioning

confidence: 99%

Trials that turn from retrospectively registered to prospectively registered: A cohort study of ‘retroactively prospective’ clinical trial registration using history data

Holst

Carlisle

2022

Preprint

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Background.Prospective clinical trial registration is a methodological best practice, a moral requirement under the Declaration of Helsinki, and in many cases legally required. The US clinical trials register ClinicalTrials.gov allows for changes to a clinical trial registry entry at any time, including changes to the clinical trial start date, making it possible for a trial that was registered after the enrolment of the first patient (retrospective registration) to retroactively change its start date to a later one, making it appear to be prospectively registered.Methods.Using the novel R package cthist, we downloaded clinical trial history data for all clinical trials with a first registration date in the year 2015.Findings.We found 235 clinical trials to be retroactively prospective, comprising 2.0% of all clinical trials first registered on ClinicalTrials.gov in 2015 and 3.9% of all prospectively registered trials. Among the 113 retroactively prospective clinical trials with an accompanying publication, 10.6% explicitly stated in the publication that they had been prospectively registered.Interpretation.While the rate of retroactively prospective trial registration is lower than hypothesized, the existence of this issue has implications for the review and conduct of clinical trials, and it can be detected using fully automated and freely available tools. This is the first analysis of the potentially questionable research practice that we call retroactively prospective trial registration.

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“…We know that prompt reporting of clinical trials allows health information to be disseminated and implemented into practice and policy [ 1 ], however in reality for many trials this is not the case. Numerous studies have shown that the unpublished research rate remains high, approximately half of all existing clinical trials are not currently published [ 2 – 8 ]. The non-publication and delayed publication of research not only affects health care planning and delivery, but it is also a failure in our obligation to trial participants who have volunteered to participate in these trials with the expectation that their participation will help others [ 9 – 11 ].…”

Section: Introductionmentioning

confidence: 99%

Publication bias in trials registered in the Australian New Zealand Clinical Trials Registry: Is it a problem? A cross-sectional study

et al. 2023

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Background Timely publication of clinical trials is critical to ensure the dissemination and implementation of high-quality healthcare evidence. This study investigates the publication rate and time to publication of randomized controlled trials (RCTs) registered in the Australian New Zealand Clinical Trials Registry (ANZCTR). Materials and methods We conducted a cross-sectional study of RCTs registered with the ANZCTR in 2007, 2009, and 2011. Multiple bibliographic databases were searched until October 2021 to identify trial publications. We then calculated publication rates, proportions, and the time to publish calculated from the date of first participation enrolment to publication date. Results Of 1,970 trial registrations, 541 (27%) remained unpublished 10 to 14 years later, and the proportion of trials published decreased by 7% from 2007 to 2011. The average time to publish was 4.63 years. The prospective trial registration rate for 2007, 2009 and 2011 was 48% (952 trials) and over this time there was an increase of 19% (280 prospective trials). Trials funded by non-Industry organizations were more likely to be published (74%, 1204/1625 trials) than the industry-funded trials (61%, 224/345 trials). Larger trials with at least 1000 participants were published at a rate of 88% (85/97 trials) and on average took 5.4 years to be published. Smaller trials with less than 100 participants were published at a lower rate with 67% (687/1024 trials) published and these trials took 4.31 years on average to publish. Conclusions Just over a quarter of all trials on the ANZCTR for 2007, 2009, and 2011 remain unpublished over a decade later. The average time to publication of nearly five years may reflect the larger trials which will have taken longer to recruit participants. Over half of study sample trials were retrospectively registered, but prospective registration improved over time, highlighting the role of mandating trial registration.

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From registration to publication: A study on Dutch academic randomized controlled trials

Cited by 6 publications

References 28 publications

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Trials that turn from retrospectively registered to prospectively registered: A cohort study of ‘retroactively prospective’ clinical trial registration using history data

Publication bias in trials registered in the Australian New Zealand Clinical Trials Registry: Is it a problem? A cross-sectional study

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