Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 –2017 cohort

Riedel, Nico; Wieschowski, Susanne; Brückner, Till; Holst, Martin R.; Kahrass, Hannes; Meerpohl, Joerg J; Salholz-Hillel, Maia; Strech, Daniel

doi:10.1016/j.jclinepi.2021.12.012

Cited by 26 publications

(48 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Additionally, it has been demonstrated that registry data regarding publications is often incomplete, necessitating manual searches for published articles [ 11 ]. These results were confirmed in a later cohort [ 12 ]. A meta-analysis of 14 methodological research studies that analyzed publication rates of registered trials after a follow-up period of at least 24 months arrived at a pooled estimate of 54.2% of published trials [ 13 ].…”

Section: Introductionsupporting

confidence: 64%

Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors

Thiele

2022

PLoS ONE

View full text Add to dashboard Cite

Introduction Analyses of clinical trial registries (CTRs) offer insights into methodological problems of published research studies, e.g., non-publication and outcome-switching. Here, we use CTRs as a tool to evaluate clinical studies conducted in Germany and test how their registration quality is associated with time and structural factors: Coordinating Centers for Clinical Trials (KKS) and Universities of Excellence. Methods We searched ClinicalTrials.gov, the DRKS, and the ICTRP for clinical trials recruiting participants in Germany. As a measure for the methodological quality, we assessed the proportion of trials that were pre-registered. In addition, the registration quality and availability of publications relating to the trials were manually assessed for a sample (n = 639). Also, the influence of the structural factors was tested using regression models. Results We identified 35,912 trials that were conducted in Germany. 59% of trials were pre-registered. Surprisingly, Universities of Excellence had lower pre-registration rates. The influence of KKS was unclear and also difficult to test. Interventional trials were more likely to be pre-registered. Registration quality improved over time and was higher in interventional trials. As of early 2021, 49% of trials that started until the end of 2015 have published scientific articles. 187 of 502 studies on ClinicalTrials.gov for which we found published articles did not reference any in the registry entry. Discussion The structural predictors did not show consistent relationships with the various outcome variables. However, the finding that the study type and time were related to better registration quality suggests that regulatory regimes may have an impact. Limitations of this non-pre-registered study were that no modifications to registry entries were tracked and the coarse measure of KKS involvement.

show abstract

Section: Introductionsupporting

confidence: 64%

Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors

Thiele

2022

PLoS ONE

View full text Add to dashboard Cite

show abstract

“…Outcomes typically have to be made public on registries within 12 months of a trial's primary completion date, which is considerably faster than typical publication timelines in peer-reviewed medical journals. 10 In 2017, WHO convened major medical research funders to sign up to the WHO joint statement on public disclosure of results from clinical trials (hereafter, WHO Joint Statement), which sets out global best practices in clinical trial registration and reporting. 11 Signatories committed to reducing research waste in their portfolios by requiring their grantees to preregister trials on a WHO-linked trial registry and make their results public on the same registry within 12 months of trial completion.…”

Section: Introductionmentioning

confidence: 99%

Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies

et al. 2022

Self Cite

View full text Add to dashboard Cite

IMPORTANCEResearch funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials. OBJECTIVE To determine the extent to which 21 major European research funders' efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study was based on 2 to 3 independent assessments of each funder's publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion.EXPOSURES Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured. MAIN OUTCOMES AND MEASURESThe primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures. RESULTS Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]).Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies. CONCLUSIONS AND RELEVANCEThis study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

show abstract

“…We used two cohorts of registered clinical trials and associated results previously developed by Wieschowski et al 29 and Riedel et al 30 and referred to as the “IntoValue” data set. 31 The data set consists of clinical trials registered on ClinicalTrials.gov or DRKS, conducted by a German university medical center, and completed between 2009 and 2017.…”

Section: Methodsmentioning

confidence: 99%

“…Trials were considered to be conducted by a German university medical center if one or more were included as a trial sponsor, overall official, and/or responsible party in ClinicalTrials.gov or provided in study addresses in DRKS; trials with a German university medical center as only a facility in ClinicalTrials.gov or recruitment location in DRKS were excluded. See Riedel et al 30 for further details on these criteria. We limited our sample to trials with results with a PubMed ID and full-text publication.…”

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers

2022

Self Cite

View full text Add to dashboard Cite

Background/Aims Informed clinical guidance and health policy relies on clinicians, policymakers, and guideline developers finding comprehensive clinical evidence and linking registrations and publications of the same clinical trial. To support the finding and linking of trial evidence, the World Health Organization, the International Committee of Medical Journal Editors, and the Consolidated Standards of Reporting Trials ask researchers to provide the trial registration number in their publication and a reference to the publication in the registration. This practice costs researchers minimal effort and makes evidence synthesis more thorough and efficient. Nevertheless, trial evidence appears inadequately linked, and the extent of trial links in Germany remains unquantified. This cross-sectional study aims to evaluate links between registrations and publications across clinical trials conducted by German university medical centers and registered in ClinicalTrials.gov or the German Clinical Trials Registry. Secondary aims are to develop an automated pipeline that can be applied to other cohorts of trial registrations and publications, and to provide stakeholders, from trialists to registries, with guidance to improve trial links. Methods We used automated strategies to download and extract data from trial registries, PubMed, and results publications for a cohort of registered, published trials conducted across German university medical centers and completed between 2009 and 2017. We implemented regular expressions to detect and classify publication identifiers in registrations, and trial registration numbers in publication metadata, abstracts, and full-texts. Results In breach of long-standing guidelines, 75% (1,418) of trials failed to reference trial registration numbers in both the abstract and full-text of the journal article in which the results were published. Furthermore, 50% (946) of trial registrations did not contain links to their results publications. Seventeen percent (327) of trials had no links, so that associating registration and publication required manual searching and screening. Overall, trials in ClinicalTrials.gov were better linked than those in the German Clinical Trials Registry; PubMed and registry infrastructures appear to drive this difference. Trial registration numbers were more likely to be transferred to PubMed metadata from abstracts for ClinicalTrials.gov trials than for German Clinical Trials Registry trials. Most (78%, 662/849) ClinicalTrials.gov registrations with a publication link were automatically indexed from PubMed metadata, which is not possible in the German Clinical Trials Registry. Conclusions German university medical centers have not comprehensively linked trial registrations and publications, despite established recommendations. This shortcoming threatens the quality of evidence synthesis and medical practice, and burdens researchers with manually searching and linking trial data. Researchers could easily improve this by copy-and-pasting references between their trial registrations and publications. Other stakeholders could build on this practice, for example, PubMed could capture additional trial registration numbers using automated strategies (like those developed in this study), and the German Clinical Trials Registry could automatically index publications from PubMed.

show abstract

Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 –2017 cohort

Cited by 26 publications

References 9 publications

Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors

Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors

Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies

Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers

Contact Info

Product

Resources

About