[Danish clinical intervention research--can it be done better?].
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Biomedical Research↗
Biomedical subjects
Christian N Gluud
Publications and source records attributed to Christian N Gluud.
[Nonabsorbable disaccharides for the treatment of hepatic encephalopathy--a systemic review of randomized clinical trials--a secondary publication].
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Humans↗
[Are treatment effects or adverse effects of significance for the association between financing and conclusions in randomized trials?].
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Bias↗
[The GCP directive--consequences for clinical drug research].
The contents and implications of the EU Directive on good clinical (research) practice (GCP) regarding drug trials are described. As of May 2003, clinical researchers in Denmark must have standard operation procedures, conduct monitoring, consider quality assurance, and expect inspections. The industry may be better prepared, but the Directive makes GCP part of the law and phase IV studies become subject to GCP. Patients will be assured the same quality in trials irrespective of the industry or investigator being the sponsor and may look forward to quality improvement of drug trials.
Adverse Drug Reaction Reporting Systems↗
[Evidence-based clinical practice].
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Clinical Medicine↗