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The NIH will now also require investigators of Phase I and Phase II trials to submit at the time of grant application "clinical monitoring plans" that explain how the trial will be conducted.
As a further incentive for moderated media communications, we support Kimmelman's [ 66] recommendation that institutional review boards require investigators of clinical trials to submit a portfolio of their press releases as a component of ethics review [ 66].
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Eight journals required authors to follow the CONSORT checklist when preparing manuscripts reporting on trials or to submit a completed checklist together with the manuscript.
Although the NIH requires all clinical trial groups to submit raw data, only one out of ten published articles include full results.The shortage of federal enforcement and regulation of research groups has led to major clinical data hoarding, making it complicated when research groups want to replicate trials to help release new drugs into the market.
The US Food and Drug Administration has encouraged clinical trial sponsors to submit pharmacogenomic data, including GWASs, on a voluntary basis [ 25].
The MHRA has 30 days to object to the trial and give the grounds for nonacceptance (for full details, see http://www.mhra.gov.uk, under How we regulate > Medicines > Licensing of medicines > Clinical trials > How to submit a clinical trial application).
Publication bias originates primarily with the investigators, and sponsors performing trials who decide whether to submit their trial for publication.
In another example, in one UK clinical trial, researchers had to submit between one and 21 copies to each of 125 ethics committees [ 40].
Bewitched women choked with fits, whereas men — who stepped forward only once the trials had begun — tended to submit to paralyzing bedroom visits.
Publication bias could result from researchers and sponsors failing to submit trials with negative results, or from favouritism towards publication of positive results among peer reviewers, journal editors and publishers.
Investigators who would like access to the trial data set are encouraged to submit a brief application, outlining rationale and analytical plan, to the trial management group for approval for additional studies.
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