BMC Medicine | Full text | Comparison of serious adverse events posted at and published in corresponding journal articles 2015-08-14


[Abstract] Background The reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at, we assessed the consistency between SAEs posted at and those published in corresponding journal articles. Methods All records from up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles. Results Among the sample of 300 trials with SAEs posted at, 78 (26 %) did not have a corresponding publication, and 20 (7 %) had a publication that did not match the record. For the 202 remaining trials, 26 published articles (13 %) did not mention SAEs, 4 (2 %) reported no SAEs, and 33 (16 %) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32 %), the number of SAEs per group published did not match those posted at For 31 trials, the number of SAEs was greater at than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11 %) had a publication reporting matching numbers of SAE and describing the type of SAE. Conclusions Many trials with SAEs posted at are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with These results underline the need to consult for more information on serious harms.


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Tags: oa.comment oa.clinical_trials oa.usa oa.pharma oa.medicine oa.biomedicine

Date tagged:

08/14/2015, 07:44

Date published:

08/14/2015, 03:44