Our voices regarding treatment-related side effects have been heard!
Earlier this year, the Patient-Centered Dosing Initiative presented the results of an MBC Patient Survey about the prevalence and severity of treatment-related toxicities to the FDA.
The result of this and similar endeavors is that the FDA has now begun advocating for Phase 1 Clinical Trials to release at least 2 doses for subsequent study in subsequent randomized trials, instead of the Maximum Tolerated Dose.
Feel free to watch the 11/10/21 conference with the FDA, Pharma, Friends of Cancer Research, and myself: youtube.com/watch?v=tO_Ta9K...
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Bestbird
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A very insightful look into the FDA as I had no idea of how it operated. I particularly liked Anne the patient advocate but I will say a lot of tryst later content went over my head. Thank you for sharing as it’s important about the MTD and I liked Anne’s acknowledgement that a lot more information is now being shared on social media about the side effects and efficacy
Hi Anne,I much appreciated your intelligent input during the first part of Day two of the online conference. I didn't learn much of interest during the second part with the FDA bureauocrats. As a former civil servant in Canada, I well know the PR needs of career civil servants. However, I think it was wise of your agency to include them in your conference now that they are onboard with the need to evaluate dosing issues.
queeneee, Thank you for your kind words! I'm hoping that after other countries hear about the FDA's new guidance, they will consider it as well! Thank you for helping to share it!
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Ibrance and others meds news
Amazing news!
Hi from the UK
