Posted by Michael Wonder on 15 Feb 2023
US Government payer funded trials to address oncology's drug dosing conundrum: a Congressional call to action?
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is better. Early phase clinical trials of new drugs therefore sought the maximum tolerated dose, which would then be compared with the standard of care in a randomised trial.
In nearly all other areas of drug development, a range of doses is evaluated before the pivotal trial is conducted. The US FDA Oncology Center of Excellence Project Optimus requires, as of 2021, dose optimisation of new oncology drugs.
However, this only applies to new drug applications—What of the cancer drugs developed and marketed before the Project Optimus effort?
