Sample size and Minimal Detectable Relative Risk

This page provides a simple power estimator for drug-outcome research. For each drug ingredient and each Health Outcome of Interest, an estimated minimal detectable relative risk (MDRR) can be computed. This MDRR can be detected given the population size of the database and the frequency of drug and outcome in 10 age and 2 gender strata:

  • The paper discussing the estimation of MDRR
  • MDRR values for all ingredients used in the Truven MSLR, MDCR, MDCD and CCAE as well as GE databases from 2003-2009 and the 35 HOIs
  • Oracle SQL query to calculate these values

The MDRR decreases over time with more and more drug exposure. It is important for newly introduced drugs to know when sufficient sample size has accumulated to power a MDRR of as low as necessary to detect typical drug outcome risks. This following provides the MDRR over time for detection the 35 HOIs for all drugs introduced to the market between 2003 and 2009 .

  • Spreadsheet with monthly MDRR values for ingredients introduced between 2003 and 2009 in the Truven MSLR, MDCR, MDCD and CCAE as well as GE databases and the 35 HOIs
  • Oracle SQL query to calculate these values

A table with all drugs and their FDA approval date can be found here.