Bioethics International has developed a benchmarking tool for “fair inclusion” in clinical trials, drawing on pivotal trials submitted to the FDA in support of 59 new cancer therapeutics – submitted by 25 sponsors – that were approved by the regulator between 2012 and 2017.
The aim is to identify those companies that are performing well on making sure trials include women, older adults, and racial and ethnic minorities, which is necessary to make sure that the outcomes of studies reflect the safety and efficacy that will be seen when therapies are used in the real world.
