Inclusion of Participants with CKD and Other Kidney-Related Considerations during Clinical Drug Development: Landscape Analysis of Anticancer Agents Approved from 2015 to 2019.
Morgan A ButrovichAllison C ReavesJamie HeywardThomas J MooreG Caleb AlexanderLesley A InkerThomas D NolinPublished in: Clinical journal of the American Society of Nephrology : CJASN (2023)
Study participants with CKD continue to be excluded from anticancer drug development, and GFR estimation in pivotal trials and renal pharmacokinetic analyses remains imprecise and heterogeneous. Furthermore, kidney-related safety and dosing information is scarcely and inconsistently presented.