3 years ago

Clinical Research Experience

Clinical Research Experience

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Potential for false negative findings if power assumptions are not assessed during trials Treatment effect on biomarker Anticipated relative risk reduction Active (n=4000) 1.0 20% 480 (12.0%) 0.7 14% 516 (12.9%) Control (n=4000) 600 (15.0%) 600 (15.0%) Power at p=0.01 91% 54% Not to check these assumptions may have adverse public health implications

SUMMARY: how can we innovate? • Innovation may be less important than doing what we already know better – Ensure that trials are LARGE enough to be informative by reducing costs per patient – Avoiding bad statistical practice (eg, country-specific subgroups, non-randomised analyses) • Quality can be built into trials by DESIGN, • Some procedures could be streamlined (eg, adjudication, on-site monitoring) • Statistical methods to improve sensitivity (but not solely as a way of reducing sample size) • Main problem in trials is type II errors: monitoring biomarkers can help avoid this

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