Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete

Wieschowski, Susanne; Riedel, Nico; Wollmann, Katharina; Kahrass, Hannes; Müller-Ohlraun, Stephanie; Schürmann, Christopher; Kelley, Seán; Kszuk, Ute; Siegerink, Bob; Dirnagl, Ulrich; Meerpohl, Joerg J; Strech, Daniel

doi:10.1016/j.jclinepi.2019.06.002

Cited by 44 publications

(86 citation statements)

References 27 publications

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“…Despite the fact, that eventually about 80% trial results were disseminated, some of them are hard to find, for example, published in non-indexed journals or not linked clearly with National Clinical Trial (NCT) identifier number. Overall dissemination rates outperformed the rates in similar studies in the USA and Germany 19 23. Nevertheless, timely reporting on the registry still remains very poor and the dissemination by both posting and publishing results was achieved by four trials (1.3%).…”

Section: Resultsmentioning

confidence: 78%

“…Overall, 3.9% (12/305) of all trials and 1.3% (1/75) of lead trials had met the criterion of posting the trial findings in the results section of the clinical trial registry within 12 months of primary study completion 15 16 18. Other research confirms such low reporting rates 20–25. This may be due to researchers’ anxiety that posting summary results in the results section on ClinicalTrials.gov will deprive them the chance to publish the same results in the journal.…”

Section: Discussionmentioning

confidence: 95%

“…Our protocol was prospectively posted on the Open Science Framework (OSF) website (https://osf.io/w4pfj/). We adapted methods used previously in similar studies 21 23…”

Section: Methodsmentioning

confidence: 99%

“…Even though the problem of under-reporting has been widely discussed and many attempts have been made to urge dissemination of trial findings at the international level, the concept of benchmarking the reporting of clinical trials across academic institutions at the country level is emerging 21 23–25…”

Section: Introductionmentioning

confidence: 99%

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Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

et al. 2020

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ObjectivesTo establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials.DesignCross-sectional study.SettingAMCs in Poland.ParticipantsAMCs with interventional trials registered on ClinicalTrials.gov.Main outcome measureResults reporting on ClinicalTrials.gov and publishing via journal publication.ResultsWe identified 305 interventional clinical trials registered on ClinicalTrials.gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials.gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%).ConclusionsOur cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare.

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Section: Resultsmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 95%

“…Our protocol was prospectively posted on the Open Science Framework (OSF) website (https://osf.io/w4pfj/). We adapted methods used previously in similar studies 21 23…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

et al. 2020

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“…On a national level, QUEST researchers recently examined rates of timely reporting for clinical trial results among all German universities. At most institutions, only 40% of clinical trial results are available within 2 years of trial completion [10]. On the basis of these data, we held a workshop to train clinicians and administrators from German universities to implement procedures to improve timely reporting of clinical trials at their institutions.…”

Section: Understanding the Problem: Research On Researchmentioning

confidence: 99%

Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative

2020

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The reproducibility crisis triggered worldwide initiatives to improve rigor, reproducibility, and transparency in biomedical research. There are many examples of scientists, journals, and funding agencies adopting responsible research practices. The QUEST (Quality-Ethics-Open Science-Translation) Center offers a unique opportunity to examine the role of institutions. The Berlin Institute of Health founded QUEST to increase the likelihood that research conducted at this large academic medical center would be trustworthy, useful for scientists and society, and ethical. QUEST researchers perform "science of science" studies to understand problems with standard practices and develop targeted solutions. The staff work with institutional leadership and local scientists to incentivize and support responsible practices in research, funding, and hiring. Some activities described in this paper focus on the institution, whereas others may benefit the national and international scientific community. Our experience, approaches, and recommendations will be informative for faculty leadership, administrators, and researchers interested in improving scientific practice. Reducing waste and improving value in biomedicine: A role for institutionsConcerns about robustness, reproducibility, and transparency have prompted worldwide initiatives to reduce waste and increase value in biomedical research [1]. Important triggers for this movement included the high failure rates of the pharmaceutical industry when trying to replicate pivotal findings of academic researchers [2]. Potential "breakthrough" therapies, which are spectacularly successful in animal models of disease, very often failed in clinical trials. At the same time, meta-research has exposed substantial weaknesses in planning, conducting, analyzing, and reporting of biomedical research [3].

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Implementing Incentives and Rewards to Improve the Research Ecosystem

Moher

2021

JAMA Netw Open

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Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete

Cited by 44 publications

References 27 publications

Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis

Improving the trustworthiness, usefulness, and ethics of biomedical research through an innovative and comprehensive institutional initiative

Implementing Incentives and Rewards to Improve the Research Ecosystem

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