Idea submitted by: Joanne Buzaglo
The Cancer Support Community (CSC) and Duke Clinical Research Institute (DCRI) want to disrupt the way the FDA and pharmaceutical companies determine the value of current and new cancer treatments by incorporating patient-determined preferences. The idea is to quantify cancer patients’ value for treatments and treatment outcomes using stated-preference research.
Regulatory decisions are informed by advisory committees largely composed of scientists and clinicians. Although the clinical trial evidence that they review may include information on patient-reported outcomes, these data do not provide direct information on the willingness of patients to accept a treatment’s risks and benefits.
We propose to design and administer a discrete-choice experiment that incorporates general positive and negative features of cancer treatment to over 7500 members in CSC’s Cancer Experience Registry (CER). The results will determine the value of cancer treatments from the patient perspective. The group will develop effective materials and publications to disseminate study results to clinical, regulatory, and patient audiences to transform the way in which the patients’ experience can be used to inform the FDA, drug developers, payers and other stakeholders in their respective decision-making processes.
The technology represents a dynamic web-based portal that uses interoperable and interactive features to connect and form a bridge between persons impacted by cancer and research. The technology allows for an interactive learning environment and ongoing patient engagement. A person or caregiver of someone living with cancer can join the Registry and create a username and password protected profile, so that they can share their experience, learn from their peers and other experts as well as participate in ongoing research.