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Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.

van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, van Hunnik M, Koëter GH, Leufkens HG, Bouter LM - BMJ Open (2015)

Bottom Line: The definite stages of progress are: rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported.We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3 months.Hence, a first draft of an article containing the results is expected before the end of October 2015.

View Article: PubMed Central - PubMed

Affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands Central Committee on Research involving Human Subjects (CCMO), The Hague, The Netherlands National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.

No MeSH data available.


Related in: MedlinePlus

Publication search algorithm. EudraCT, European Union Drug Regulating Authorities Clinical Trials: obligatory registration database for clinical drug trials carried out in the European Union.
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BMJOPEN2015007827F2: Publication search algorithm. EudraCT, European Union Drug Regulating Authorities Clinical Trials: obligatory registration database for clinical drug trials carried out in the European Union.

Mentions: We search for publications on the trial results in the scientific literature using a standardised algorithm (figure 2). A publication is defined as a peer-reviewed article containing at least methods and results. All reports not fulfilling this publication (eg, results reported in registries, conference abstracts containing results, trial summaries on sponsor websites containing methods and results) will be also collected. Peer-reviewed publication is in our opinion the golden standard for reporting clinical research, but trial results can be reported by other means (eg, registries, sponsor websites, conference abstracts). Using only peer-reviewed articles as end point for non-publication is in line with the majority of other research.47 If we identify more than one publication of trial results, we classify the publication as either primary (ie, containing the overall results and conclusions) or secondary (ie, interim, post hoc, subgroup or other analysis). In general, we assume that this will be clearly stated in the publications.42 Other information collected includes the full-text of the article, the journal and the first date of publication (eg, advance online publication). We have completed this part of the publication search in March 2015.


Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.

van den Bogert CA, Souverein PC, Brekelmans CT, Janssen SW, van Hunnik M, Koëter GH, Leufkens HG, Bouter LM - BMJ Open (2015)

Publication search algorithm. EudraCT, European Union Drug Regulating Authorities Clinical Trials: obligatory registration database for clinical drug trials carried out in the European Union.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4499740&req=5

BMJOPEN2015007827F2: Publication search algorithm. EudraCT, European Union Drug Regulating Authorities Clinical Trials: obligatory registration database for clinical drug trials carried out in the European Union.
Mentions: We search for publications on the trial results in the scientific literature using a standardised algorithm (figure 2). A publication is defined as a peer-reviewed article containing at least methods and results. All reports not fulfilling this publication (eg, results reported in registries, conference abstracts containing results, trial summaries on sponsor websites containing methods and results) will be also collected. Peer-reviewed publication is in our opinion the golden standard for reporting clinical research, but trial results can be reported by other means (eg, registries, sponsor websites, conference abstracts). Using only peer-reviewed articles as end point for non-publication is in line with the majority of other research.47 If we identify more than one publication of trial results, we classify the publication as either primary (ie, containing the overall results and conclusions) or secondary (ie, interim, post hoc, subgroup or other analysis). In general, we assume that this will be clearly stated in the publications.42 Other information collected includes the full-text of the article, the journal and the first date of publication (eg, advance online publication). We have completed this part of the publication search in March 2015.

Bottom Line: The definite stages of progress are: rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported.We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3 months.Hence, a first draft of an article containing the results is expected before the end of October 2015.

View Article: PubMed Central - PubMed

Affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands Central Committee on Research involving Human Subjects (CCMO), The Hague, The Netherlands National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.

No MeSH data available.


Related in: MedlinePlus