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Benefit/Risk Estimates in Clinical Trials

Title
Benefit/Risk Estimates in Clinical Trials

Abstract
Most current benefit/risk analyses of drugs in clinical trials are qualitative and subjective. This study details the development of scientific and objective equations to numerically estimate the benefit/risk (B/R) ratio. The methodology in this study is to consider different severity levels of adverse events and improvement of symptoms by assigning different weights to them. The set of equations to calculate the B/R ratio take into consideration the clinical data’s inherent uncertainties due to sample size, adverse event reporting, and many other factors. Furthermore, the uncertainties of clinical trial data are taken into account by treating the benefit and risk as random variables, utilizing the reliability index, and performing the firstorder analysis to evaluate the benefit and risk of the treatment. The methodology discussed can be used on quantitative assessments of not only drugs in clinical trials but also drug treatments of patients. To test the B/R ratio calculation, we applied the method to two large clinical trials obtained from published literature. This experimental approach could assist clinical investigators and regulatory oversight groups in comparing and determining the suitability of various clinical trials and drug treatments by providing a quantitative analysis beyond the existing subjective methods.