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.
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.
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. Monique Gary, a breast cancer surgeon, pointed out: “We don’t talk enough about that. We shame, and we make people feel bad that they can’t continue or complete the dose.”
The speakers emphasized the importance of tailoring dosing to individual patients. Stephanie Walker, another breast cancer patient advocate, stated: “I believe that if we could get all patients to have the conversation, I think it would be a win-win for all groups.”
Key takeaways for patients included discussing dosing with their doctor, sharing priorities for treatment, addressing side effects promptly, and collaborating on treatment decisions. Maués added: “We often see that the medication that are needed to tolerate the side effects, the best ones are not covered, then you have to go with the second best, then it might not be the same.”
The speakers discussed ongoing efforts to improve how dosing is determined in clinical trials. Julia Maués mentioned: “The FDA has an initiative called Project Optimus where they are going to make pharma do trials that look at maybe more doses than these early trials and move two or three doses to phase two.” This approach could help identify more optimal doses for different patient groups.
A key message throughout the discussion was the importance of patients speaking up about their experiences and needs. TOUCH founder and breast cancer survivor Ricki Fairley emphasized: “We have to do it, and we have to – you know, we feel so victimized by cancer. We feel like we have no power. Like, there’s so many things that we feel like out of our control. You know, you guys know what I’m talking about.”
Dr. Gary added: “Don’t lose your power. Cancer takes enough things from you. Don’t give up your pen.”
By encouraging more patient-centered approaches in clinical trials and empowering patients to advocate for themselves, the speakers hope to improve treatment experiences and outcomes for cancer patients.
For more information on patient-centered dosing initiatives, visit therightdose.org or email [email protected].
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