Are Standard-of-Care Treatments in Clinical Trials Really ‘Standard’?
Posted: Thursday, November 9, 2017
For valid evaluation of novel treatments in clinical trials, comparison against the current standard of care is essential. However, Rachel F. Dear, MBBS, PhD, of the University of Sydney, and colleagues found that 29% of the 210 breast cancer clinical trial studies they analyzed lacked control arms that were consistent with the standard of care.
“An inappropriate comparator, such as a drug or dose that is less effective than the standard of care, may result in a new treatment appearing more effective than it really is,” said Dr. Dear and colleagues in the Journal of the National Comprehensive Cancer Network.
This study reviewed 210 phase III randomized breast cancer clinical trials comparing drug treatments with “standard care” between 2004 and 2014, including more than 229,000 patients. The investigators found that 60 of these trials did not provide control group treatment in line with the concurrent standard of care. In addition, a higher number of trials that recruited patients outside the United States were not consistent with the National Comprehensive Cancer Network Guidelines® compared with those that recruited patients in the United States (39% vs. 13%).
“Better guidance needs to be available to investigators to ensure provision of the best current care to patients in control groups of clinical trials,” the investigators concluded.