"I disagree that medicine is plagued by untrustworthy clinical trials, and particularly object to the view that you quote: “If you search for all randomized trials on a topic, about a third of the trials will be fabricated” (Nature 619, 454–458; 2023). That opinion is not backed by independently verified data, so I find this reporting sensationalistic and potentially offensive to medical authors.
Errors in trials can have many causes apart from negligence or fraud. All such cases should be investigated meticulously, and the responsible author(s) formally punished in cases of proven wrongdoing. Articles, their reported data and the authors should not be considered as untrustworthy from the outset.
Clinical trials aimed at regulatory submission must comply with guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH; see go.nature.com/3vkms), in particular sections E6 (on good clinical practices) and E8 (on general considerations for clinical-trial design). Those trials should meet strict ethical and scientific standards. They should incorporate quality control and quality assurance based on monitored data and audited processes. This generates a verifiable trail of information. Publishers should require authors to declare that ICH guidelines have been followed and should request more information in cases of doubt." [1]
1. Nature 621, 42 (2023). By Eduardo F. Motti
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