Thank you for participating in the MS Caregiver Patient-Focused Drug Development survey.
Patient-Focused Drug Development (PFDD) is an initiative from the Food and Drug Administration (FDA) that incorporates the patient perspective into the development and evaluation of new medicines. The goal of PFDD is that patients are able to voice their perspectives, experiences, needs, and priorities on specific diseases and their treatments. Through the PFDD process, individuals impacted by a specific disease share their personal experiences of living with the disease, and share insights on treatment impacts that would be most important or beneficial.
The FDA’s description of PFDD includes not only patient input but also the input of caregivers.
Participation in PFDD may include:
* identifying what symptoms matter most to patients and their caregivers, and what outcomes should be measured to determine if a treatment is working;
* identifying ways to increase patient participation in clinical trials including how to reduce the burdens and obstacles of participating;
* providing input on how to capture information related to patient and caregiver preferences related to treatments and how patients and caregivers think about the tradeoffs between treatment benefits and risks;
* identifying the information that is most important to patients and caregivers related to understanding treatment benefits, risks, and burden; and,
* providing suggestions as to how to communicate clearly with patients and caregivers throughout the clinical trial design, recruitment, and reporting process.
For the purposes of this project, we are defining a caregiver as someone who provides unpaid assistance to a relative, friend, or neighbor requiring help with activities of daily living related to managing multiple sclerosis (MS). The role of MS caregivers in PFDD is an emerging topic of interest as industry, the FDA, and advocacy organizations such as Accelerated Cure Project/iConquerMS are looking to better understand the caregiver perspective on participating in PFDD.
This survey will gather information from MS caregivers about their awareness of PFDD and their interest in participating in it.
This survey is expected to take 10 minutes to complete.