Starting in 2012 the Food and Drug Administration (FDA) began to integrate the patient perspective into the drug development process through their Patient-Focused Drug Development (PFDD) initiative. As part of this initiative the FDA held 24 disease-specific meetings to gather input directly from patients about what it is like to live with a specific condition with the hope that this input would be taken into consideration when the FDA is reviewing applications for the approvals of new drugs. These meetings began a culture change of including the patient perspective into drug development and approval. CSC is very supportive of including the voice of the patient in the drug development process and we have been working closely with the FDA, and other researchers, to explore ways to do so in a more meaningful way.
A cornerstone of the Cancer Support Community’s mission is to better understand the full patient experience and our work at the Cancer Policy Institute translates the findings from our Cancer Experience Registry into policy discussions with legislators and regulators such as those at the FDA. The FDA is continuing to incorporate the patient voice into their workflow and the recent sixth authorization of the Prescription Drug Reauthorization Act has laid out more opportunities for patients and advocates to provide feedback as to how the FDA should incorporate the voice of the patient. It is incredibly important that the patient community engage with the FDA in these conversations.
Think about the 1988 blockbuster movie Big where Josh Baskin turns from a 12-year-old boy into a 30-year-old man after making a wish on a “Zoltar Speaks” wish machine and soon after finds himself working for MacMillen Toy Company. Because Josh was really just a young boy, he understood what mattered most to children when it came to playing with toys. And because Josh brought the voice of the child to the table, he was able to tell MacMillen which toys were cool and meaningful to children, and which missed the mark. Without knowing they were doing it, MacMillen was incorporating the voice of the children, their target market, into the toy development process. Now imagine how much better the drug development process would be if the voice of the patients was continuously incorporated from early on in the process of designing research, through to approval of the product and forward into the post-marketing surveillance studies. Patients need to be involved to tell the FDA and the research community what truly matters most, so that these factors can be measured during the clinical trial and drug development process, allowing drugs to be developed that meet the needs of patients.
The patient advocacy community can and should partner with the FDA to ensure that they are measuring the full patient experience in clinical trials to include the physical, social, and emotional impacts of a therapy. We know that the social and emotional impact of cancer is undeniable and that distress related to cancer can also negatively impact a patient’s adherence to their treatment plan and ultimately their path towards better health.
How can you share your voice to help the FDA measure what matters most to patients?
- Share your experience by joining the Cancer Experience Registry (for patients, survivors, and caregivers)
- Join our Grassroots Advocacy Network to stay up to date on opportunities to comment about proposed regulations and guidance with the FDA
- Read some of CSC’s comments to the FDA about the drug development and approval process
- Read more about Patient-Focused Drug Development
- Learn more about the FDA, the drug development process, and where to add your voice at ProgressForPatients.org
- Learn about the FDA’s Patient Engagement Advisory Committee
- Learn about the National Cancer Institute (NCI) Office of Advocacy Relations and the NCI Council of Research Advocates
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- Welcoming Kim Czubaruk to the Cancer Support Community
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- Shared Decision Making and Value Based Cancer Care Research