[Statistically validated evaluation of clinical trials].
Data of clinical trials of medicinal products must be evaluated in statistically valid models. The statistical validity criteria are defined. Statistically invalid models will result in biased parameter and confidence interval estimations, erroneous statistical inferences and clinical interpretations. Finally, wrong decisions will call forth deleterious consequences in the judgement of the therapeutic effect and the frequency and severity of the adverse reactions of the tested new medicinal, and generic products. Statistically validated analyses will promote the international harmonization of the scientific evaluation of medicinal products according to the idea of the evidence-based-medicine. The study presents examples of clinical trials evaluated with a software checking statistical validity assumptions while performing evaluation of data.
Lugosi
L
L
MEDISTAT Szoftver Kutató és Fejlesztö Társaság, Budapest.
Molnár
I
I
D002986:Clinical Trials as Topic / Q000592:standards*; D003627:Data Interpretation, Statistical; D006801:Humans
Klinikai vizsgálatok statisztikailag validált értékelése.