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Research article
Anette Blümle
Institute for Evidence in Medicine (for Cochrane Germany Foundation)
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2877-1029
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Decisions in healthcare are ideally made on basis of the results of clinical trials, published in study registries, as primary journal articles or summarized in secondary research articles. It is still unclear, whether and to what extent public and commercial expenses invested in clinical trials pays out in a way that their findings have an impact on publication output and medical practice.
Methods
The aim of this project was to examine the lifecycle of clinical trials from their registration to their publication and citation in secondary research articles by determining the proportion of trials that were published and were included in systematic review and clinical guidelines.
We set-up a cohort of randomized controlled trials (n=691). We created and compared four sub-cohorts of investigator initiated trials (IITs) and industry sponsor trials (ISTs) with and without German contribution. For each trial, we searched for corresponding publications and citing systematic reviews and clinical guidelines.
Additionally, we investigated what study characteristics are associated with publication and impact by using multivariable logistic regressions.
Results
Of the 691 trials, 576 (83%) were published as method article or result article in a medical journal and/or the trial results were made available in study registries; results were available for 555 (80%) of the trials. More than half (52%) of the trials were cited by a systematic review and about a quarter (26%) reached impact in a clinical guideline. Drug trials and larger trials are 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 journal article, results of ISTs more often in study registries. International ISTs gain less often impact by inclusion in systematic reviews or guidelines than publicly sponsored trials.
Conclusion
A considerable proportion of clinical trials investigated was published and had an impact on clinical practice, whereas the proportions depend on specific study characteristic. Study registries are an important alternative or complement to journal articles for publishing study results. There is still a need to improve the transfer of knowledge generated in clinical research into practice.
Keywords
Randomized controlled trial, study registry, access to information, evidence-based medicine, systematic reviews, clinical guidelines, knowledge translation, clinical decision making, investigator initiated trials, industry sponsored trials
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This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.docx
Sources where published articles were identified
- Additionalfile1.docx
Sources where published articles were identified
- Additionalfile2.docx
Number of published articles
- Additionalfile2.docx
Number of published articles
- Additionalfile3.docx
Publication frequency: Proportion of trials (total: n=472) with n published method and results articles (total: n=947)
- Additionalfile3.docx
Publication frequency: Proportion of trials (total: n=472) with n published method and results articles (total: n=947)
- Additionalfile4.docx
Study characteristics associated with publication of trial results
- Additionalfile4.docx
Study characteristics associated with publication of trial results
- Additionalfile5.docx
Medical Fields
- Additionalfile5.docx
Medical Fields
- Additionalfile6.docx
Number of published articles cited by systematic reviews and/or by clinical guidelines per sub-cohort and type of publication
- Additionalfile6.docx
Number of published articles cited by systematic reviews and/or by clinical guidelines per sub-cohort and type of publication
- Additionalfile7.docx
Citation frequency for published articles (n=599) by systematic reviews (n=2631)
- Additionalfile7.docx
Citation frequency for published articles (n=599) by systematic reviews (n=2631)
- Additionalfile8.docx
Study characteristics associated with citation by systematic reviews
- Additionalfile8.docx
Study characteristics associated with citation by systematic reviews
- Additionalfile9.docx
Study characteristics associated with citation by guidelines
- Additionalfile9.docx
Study characteristics associated with citation by guidelines
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CURRENT STATUS: Under Revision
Version 1
Posted 18 Nov, 2020
No community comments so far
Editorial decision: Major revision
On 24 Dec, 2020
Review #1 received
Received 23 Dec, 2020
Review #2 received
Received 21 Nov, 2020
Reviewer #2 agreed
On 12 Nov, 2020
Reviewer #1 agreed
On 10 Nov, 2020
Reviewers invited
Invitations sent on 09 Nov, 2020
First submitted
On 08 Nov, 2020
Editor assigned
On 08 Nov, 2020
Submission checks complete
On 08 Nov, 2020
Editor invited
On 08 Nov, 2020
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at BMC Medical Research Methodology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Anette Blümle
Institute for Evidence in Medicine (for Cochrane Germany Foundation)
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2877-1029
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Revision
Version 1
Posted 18 Nov, 2020
No community comments so far
Editorial decision: Major revision
On 24 Dec, 2020
Review #1 received
Received 23 Dec, 2020
Review #2 received
Received 21 Nov, 2020
Reviewer #2 agreed
On 12 Nov, 2020
Reviewer #1 agreed
On 10 Nov, 2020
Reviewers invited
Invitations sent on 09 Nov, 2020
First submitted
On 08 Nov, 2020
Editor assigned
On 08 Nov, 2020
Submission checks complete
On 08 Nov, 2020
Editor invited
On 08 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Decisions in healthcare are ideally made on basis of the results of clinical trials, published in study registries, as primary journal articles or summarized in secondary research articles. It is still unclear, whether and to what extent public and commercial expenses invested in clinical trials pays out in a way that their findings have an impact on publication output and medical practice.
Methods
The aim of this project was to examine the lifecycle of clinical trials from their registration to their publication and citation in secondary research articles by determining the proportion of trials that were published and were included in systematic review and clinical guidelines.
We set-up a cohort of randomized controlled trials (n=691). We created and compared four sub-cohorts of investigator initiated trials (IITs) and industry sponsor trials (ISTs) with and without German contribution. For each trial, we searched for corresponding publications and citing systematic reviews and clinical guidelines.
Additionally, we investigated what study characteristics are associated with publication and impact by using multivariable logistic regressions.
Results
Of the 691 trials, 576 (83%) were published as method article or result article in a medical journal and/or the trial results were made available in study registries; results were available for 555 (80%) of the trials. More than half (52%) of the trials were cited by a systematic review and about a quarter (26%) reached impact in a clinical guideline. Drug trials and larger trials are 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 journal article, results of ISTs more often in study registries. International ISTs gain less often impact by inclusion in systematic reviews or guidelines than publicly sponsored trials.
Conclusion
A considerable proportion of clinical trials investigated was published and had an impact on clinical practice, whereas the proportions depend on specific study characteristic. Study registries are an important alternative or complement to journal articles for publishing study results. There is still a need to improve the transfer of knowledge generated in clinical research into practice.
Figure 1
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Figure 3
Figure 4
Figure 4
Figure 5
Figure 5
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This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.docx
Sources where published articles were identified
- Additionalfile1.docx
Sources where published articles were identified
- Additionalfile2.docx
Number of published articles
- Additionalfile2.docx
Number of published articles
- Additionalfile3.docx
Publication frequency: Proportion of trials (total: n=472) with n published method and results articles (total: n=947)
- Additionalfile3.docx
Publication frequency: Proportion of trials (total: n=472) with n published method and results articles (total: n=947)
- Additionalfile4.docx
Study characteristics associated with publication of trial results
- Additionalfile4.docx
Study characteristics associated with publication of trial results
- Additionalfile5.docx
Medical Fields
- Additionalfile5.docx
Medical Fields
- Additionalfile6.docx
Number of published articles cited by systematic reviews and/or by clinical guidelines per sub-cohort and type of publication
- Additionalfile6.docx
Number of published articles cited by systematic reviews and/or by clinical guidelines per sub-cohort and type of publication
- Additionalfile7.docx
Citation frequency for published articles (n=599) by systematic reviews (n=2631)
- Additionalfile7.docx
Citation frequency for published articles (n=599) by systematic reviews (n=2631)
- Additionalfile8.docx
Study characteristics associated with citation by systematic reviews
- Additionalfile8.docx
Study characteristics associated with citation by systematic reviews
- Additionalfile9.docx
Study characteristics associated with citation by guidelines
- Additionalfile9.docx
Study characteristics associated with citation by guidelines
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