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While group-sequential testing is regularly done in pivotal clinical trials with therapeutic intent, it is much less common in diagnostic trials.
If confirmed, larger randomised diagnostic trials will be necessary to determine whether myocardial perfusion imaging by CT will be beneficial compared with established options using appropriate clinically relevant endpoints.
In diagnostic trials, clustered data are obtained when several subunits (e.g., organs or vessels) of the same patient are observed where no, several, or all subunits may be diseased or non-diseased as classified by a gold standard.
The result publication rates for trials of preventative and health services research were higher than those of supportive care, treatment and diagnostic trials.
Lack of methodological rigour in diagnostic trials is a cause for concern as it may prove to be a major hurdle for effective application of diagnostics in controlling TB, malaria and HIV.
Diagnostic trials are different from therapeutic trials, requiring different scientific approaches and expertise.
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General considerations in the design of evaluation of diagnostic test trials and statistical principles for reporting the results are discussed.
Ethyl glucuronide (EtG) has been proven to be a reliable biomarker for the detection of recent drinking; however, no randomized, diagnostic trial to date has tested its impact on drinking outcomes.
A cluster randomized diagnostic trial.
This is a prospective diagnostic trial.
The study is a prospective diagnostic trial.
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