More than half of studies testing anticancer drugs against each other have rules with regard to dose modification and growth support 𝘵𝘩𝘢𝘵 𝘧𝘢𝘷𝘰𝘳 𝘵𝘩𝘦 𝘦𝘹𝘱𝘦𝘳𝘪𝘮𝘦𝘯𝘵𝘢𝘭 𝘥𝘳𝘶𝘨 arm, new analysis suggests.
More than half of studies testing anticancer drugs against each other have rules with regard to dose modification and growth support that favor the experimental drug arm, a new analysis suggests.
Olivier, with UCSF co-investigators Alyson Haslam, PhD, and Vinay Prasad, MD, report their findings online July 10 in theDifferent drug modification rules or growth factor support guidance may affect the results of randomized controlled trials of testing new cancer agents. The researchers assessed imbalance in drug modification rules, myeloid growth factor recommendations, or both, according to pre-specified rules.
“If you introduce unfair rules about dose modification or supporting medication that favors the new drug, then you don’t know if a positive trial is due to the effect of the new drug or to the effect of differential dosing or supporting medication,” he added.Olivier said the fact that most registration trials are industry-sponsored is likely the primary explanation of the findings.
Institutional review boards and drug regulators could also systematically evaluate drug dosing modification and supportive medication rules before a trial gets underway.
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