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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

Overview of stages of progress of the 2007 inception cohort of clinical drug trials in the Netherlands. The numbers in the boxes indicate the numbers of trials that succeeded to the specific stages of progress. From B1, C1, D1, E1 to F1 is the ‘perfect’ flow of a trial in the cohort, meaning that all aspects took place according to the application. The sum of the boxes B2, C2, E2 F1 and F2, which are the five final stages of progress, will be 622.
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BMJOPEN2015007827F1: Overview of stages of progress of the 2007 inception cohort of clinical drug trials in the Netherlands. The numbers in the boxes indicate the numbers of trials that succeeded to the specific stages of progress. From B1, C1, D1, E1 to F1 is the ‘perfect’ flow of a trial in the cohort, meaning that all aspects took place according to the application. The sum of the boxes B2, C2, E2 F1 and F2, which are the five final stages of progress, will be 622.

Mentions: For the 622 trials in the inception cohort, we will determine the various stages of progress (figure 1). For each clinical drug trial, we will discriminate 10 stages of progress. Of these, five are intermediate (meaning that further action is observed or possible), and five are definite (meaning that no further action is observed or possible). We named the stages of progress according to the flow of the cohort, shown in figure 1. The intermediate stages of progress are: B1 approved by IRB; C1 started inclusion; D1 completed as planned; D2 terminated early; E1 published as article. The definite stages of progress are: B2 rejected by IRB; C2 Never started inclusion; E2 Not published as article; F1 completely reported; F2 selectively reported. We primarily aim to investigate the publication-related stages of progress E1, E2, F1 and F2. However, to understand why these stages of progress are not reached, we also determine the other stages of progress. The stage of progress F2 (selectively reported) is definite for the end of our data collection; later publications can still fill the remaining gaps by moving trials to F1 (completely reported).


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)

Overview of stages of progress of the 2007 inception cohort of clinical drug trials in the Netherlands. The numbers in the boxes indicate the numbers of trials that succeeded to the specific stages of progress. From B1, C1, D1, E1 to F1 is the ‘perfect’ flow of a trial in the cohort, meaning that all aspects took place according to the application. The sum of the boxes B2, C2, E2 F1 and F2, which are the five final stages of progress, will be 622.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

BMJOPEN2015007827F1: Overview of stages of progress of the 2007 inception cohort of clinical drug trials in the Netherlands. The numbers in the boxes indicate the numbers of trials that succeeded to the specific stages of progress. From B1, C1, D1, E1 to F1 is the ‘perfect’ flow of a trial in the cohort, meaning that all aspects took place according to the application. The sum of the boxes B2, C2, E2 F1 and F2, which are the five final stages of progress, will be 622.
Mentions: For the 622 trials in the inception cohort, we will determine the various stages of progress (figure 1). For each clinical drug trial, we will discriminate 10 stages of progress. Of these, five are intermediate (meaning that further action is observed or possible), and five are definite (meaning that no further action is observed or possible). We named the stages of progress according to the flow of the cohort, shown in figure 1. The intermediate stages of progress are: B1 approved by IRB; C1 started inclusion; D1 completed as planned; D2 terminated early; E1 published as article. The definite stages of progress are: B2 rejected by IRB; C2 Never started inclusion; E2 Not published as article; F1 completely reported; F2 selectively reported. We primarily aim to investigate the publication-related stages of progress E1, E2, F1 and F2. However, to understand why these stages of progress are not reached, we also determine the other stages of progress. The stage of progress F2 (selectively reported) is definite for the end of our data collection; later publications can still fill the remaining gaps by moving trials to F1 (completely reported).

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