2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is — on the surface — good news for people with cancer.
But some of these approvals were based on clinical trials with substandard control arms, calling into question the effectiveness of some new drugs.
Drug approvals generally require randomised clinical trials in which an investigational agent is compared to a control, usually an established treatment. If the investigational agent is superior to the control, FDA approval is likely.
The choice of the treatment received by participants in the control arm is essential. It should be the current best standard of care. But it isn’t uncommon for the established agent chosen as the standard of care to be outdated, or something that practicing oncologists rarely or never use.