Diagnosing fraudulent baseline data in clinical trials
نویسندگان
چکیده
منابع مشابه
Baseline data in clinical trials.
ALTHOUGH REPORTING BASELINE DATA seems simple, it is crucial information for readers in judging the validity of a trial. Knowing the baseline characteristics of the trial participants allows readers to assess how closely these match patients seen in their own clinical practice, and therefore how generalisable the results of the trial will be (so-called external validity). Baseline characteristi...
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Once the data from a clinical trial are available for analysis it is common practice to carry out 'tests of baseline homogeneity' on prognostic covariates before proceeding to analyse the effects of treatment on outcome variables. It is argued that this practice is philosophically unsound, of no practical value and potentially misleading. Instead it is recommended that prognostic variables be i...
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Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country’s drug regulator. An investigation of data for 1622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration said that 1308 of the applications should be withdrawn because they contained fabricated, flawed, or i...
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BACKGROUND Baseline data collected on each patient at randomisation in controlled clinical trials can be used to describe the population of patients, to assess comparability of treatment groups, to achieve balanced randomisation, to adjust treatment comparisons for prognostic factors, and to undertake subgroup analyses. We assessed the extent and quality of such practices in major clinical tria...
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In clinical trials investigating the treatment of chronic, progressive diseases, a common design is to make some physiologic measurement of the disease state at the start of the trial, randomize patients to either the experimental treatment or some control treatment (placebo), follow the patients over some period of time, and then measure once again the physiologic measurement of the disease st...
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ژورنال
عنوان ژورنال: PLOS ONE
سال: 2020
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0239121