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Although neonatal RCTs constituted only 7% of the trials in our database [ 7], severe ADRs were prominent in the neonatal RCTs reviewed.
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Comparability with the group of patients treated beyond the 4.5 hour time window in the randomised controlled trials is limited because maximum time from onset to treatment in the trials was six hours, while in our database, almost 400 patients were treated beyond six hours after stroke onset.
We did not evaluate the relationship of serum bilirubin concentrations with the other known or reported prognostic factors in PBC; the data on prothrombin time was not available in the randomised trials of UDCA, and neither in our database, as prothrombin time values are not routinely measured during followup of PBC patients.
This may have been due to the age of our trials and the out of date contact details for lead researchers on older trials in the database we used.
The presence of such trials in the database confers "undeserved legitimacy," he says.
However, we assume that NI trials retrieved from PubMed do not have different methodological characteristics than NI trials in other databases, so we do not think that this influenced our results.
Many researchers are ignoring a 2005 requirement that they register proposed clinical trials in a government database as a condition for publishing their results in medical journals.
In 2004, Drazen and editors at other journals made it much harder for companies to hide unflattering experiments, requiring drugmakers to register a summary description of their trials in a public database.
We conducted a literature search of relevant randomized clinical trials in the PubMed database and ongoing trials in Clinicaltrials.gov.gov
Two years ago, drug companies promised to register research trials in a public database and disclose outcomes as soon as possible.
2% (89/3812) of trials in the mRCT database described the use of qualitative research undertaken with the trial.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com