Drug Quality and Gender Parity of Clinical Trial Participants
AbstractDespite rapid advancements in medical technologies since the dawn of the 20th century, women are nearly two times more likely to experience an adverse drug event (ADE) than men. Existing literature concerned with the production of effective innovation point to short FDA review times, drug novelty, and duration of time between foreign and U.S. market launch as potential drivers of adverse drug events. However, it does not consider the extent to which clinical trial gender composition signal post market drug risks for women. Given that biological differences between sexes may lead to differential responses to a given drug treatment, gender disaggregated clinical trial results can inform regulator (un)certainty about safety risks new drugs pose for different populations. Using a novel dataset containing information on clinical trials and U.S. adverse drug reactions, this study exploits the 2012 FDA Safety and Innovation Act (FDASIA) requirement to report clinical trial results by sex to estimate the causal impact of clinical trial gender composition on risks associated with therapeutically novel drugs.
This is the first study to examine the effects of the 2012 FDASIA requirement to report clinical trial results by sex on ADE and a production function of effective innovation with the proportion of female clinical trial participants as an input. Three types of ADEs are considered including those leading to (1) death, (2) hospitalization, and (3) other serious events. An event study and difference-in-differences model is used to estimate the effect of clinical trial gender composition on adverse drug reactions.