diseaseDate: April 28, 2015
Time: 9:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
(Enter at Building 1 to clear security)
On April 28, 2015, FDA is conducting a public meeting on Chagas Disease Patient-Focused Drug Development. FDA is interested in obtaining patient input on symptoms and daily impacts that matter most to patients (topic 1), and current available approaches to treating chagas disease (topic 2). The questions for discussion on these topics are below.
For each of these topics, a panel of patients and patient representatives/advocates will present comments to begin the dialogue and will be followed by a facilitated discussion inviting comments from all patients and patient representatives in the audience.
If you are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Panelists will be confirmed prior to the meeting.
There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign-up for Open Public Comment will take place the day of the meeting.
Webcast participants will also have an opportunity to provide input through webcast comments.
For more information, refer to the FDA meeting website at: http://www.fda.gov/Drugs/NewsEvents/ucm420130.htm.
Questions for Discussion
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
1) What worries you most about your condition?
2) Do you have symptoms that you experience because of your condition? If so, of all the symptoms that you experience, which 1-3 symptoms have the most significant impact on your life? (Examples may include irregular heartbeat, shortness of breath, difficulty swallowing, stomach pain or constipation)
3) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, being a blood or organ donor, or for women in reproductive age concern about getting pregnant and transmitting the infection to your children, etc.)
4) How have your condition and its symptoms changed over time?
5) Do your symptoms come and go? If so, do you know of anything that makes your symptoms better or worse?
Topic 2: Patient Perspectives on Current Approaches to Treat Chagas Disease:
1) What are you currently doing to help treat your condition? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as diet modification.)
a) What specific symptoms do your treatments address?
b) How has your treatment regimen changed over time, and why?
2) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, length of treatment, number of pills to take daily, going to the hospital for frequent check-up or treatment, restrictions on driving, potential consequences to your health and your child’s health during pregnancy, etc.)
3) What specific things would you look for in an ideal treatment for your condition?