Opinion: Substandard control arms question the utility of some new cancer drugs
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 randomized 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 are used, the newly approved drug wasn’t really compared to the standard of care. That can leave oncologists and patients wondering if a new drug is better than existing treatments, which may also be less expensive.
