pharmacovigilance signal detection quantitative methods clinical trials statistics clinical development of medicines quackery homeopathy health technology evaluation health technology assessment medicines drug development medicinal products spontaneous reporting system databases cioms viii bad research causal inference internal validity bayesian statistics charlatanism charlatanisme fakemed fakemeds homeopathie cancer cancer medicines potarddechaine youpi subgroup analyses biomarkers oncology platform umbrella baskets dice statistical test power conditional approval regulation of medicines real world evidence adaptive pathways european medicines agency european union marketing authorisations procedures in the eu centralised procedure ema-hta parallel advice national institute for health and care excellence scientific advice health economics time to onset adverse drug reactions signal management spontaneous reporting systems signal prioritisation hypothesis testing compliance intention-to-treat protocol deviation assay sensitivity non-inferiority per protocol principal component analysis prioritisation masking ror rrr pharmacoviiglance confidence interval prr
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