Why We Need Patient-Centered Dosing in Clinical Trials

Clinical trials play a crucial role in developing new cancer treatments, but how drug dosing is determined in these trials can significantly impact patients. A recent discussion on BlackDoctor.org between cancer advocates and medical professionals highlighted the need for more patient-centered approaches to dosing. How drug dosing is determined Julia Maués, a metastatic breast cancer patient advocate, explained how cancer drug dosing is typically established: “The way that cancer drug dosing is determined is in the early phase clinical trials. They probably have animal [tests] that indicate what dose would be right for a human. And then at some point, they have that first [human] trial, and they try different doses until they get to a dose that the patients can’t tolerate.” She noted that these trials often involve very small numbers of patients, sometimes as few as one to three people per dose level. Once the maximum tolerated dose is found, that becomes the recommended dose for larger trials and eventual widespread use. Challenges with current dosing approaches Several issues with this approach were discussed, including limited diversity in early trials, short observation periods for side effects, and lack of consideration for long-term tolerability, especially for metastatic patients. Dr....