FDA Public Meeting for Patient-Focused Drug Development on Chronic Pain

https://www.eventbrite.com/e/public-meeting-for-patient-focused-drug-development-on-chronic-pain-registration-44555070415

On July 9, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Chronic Pain. FDA is interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.

The questions that will be asked of patients and patient representatives at the meeting are listed below, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patients and patient representatives in the audience. Webcast participants will also have an opportunity to provide input through webcast comments. 

If you are attending the meeting in person and are interested in providing comments as part of the initial panel discussion on July 9^th, indicate so during the registration process. Potential panelists must send a brief summary of responses to the discussion questions below by June 25^th to PatientFocused@fda.hhs.gov. Panelists will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient stakeholders 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 occur on-site during the day of the meeting.

For more information, please visit the FDA meeting website: 

https://www.fda.gov/Drugs/NewsEvents/ucm603093.htm.

 DISCUSSION QUESTIONS

Topic 1: Symptoms and daily impacts of chronic pain that matter most to patients

1. How would you describe your chronic pain? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)
2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)
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 chronic pain? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
4. How has your chronic pain changed over time? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities)

Topic 2: Patients’ perspectives on current approaches to treatment of chronic pain

1. What are you currently doing to help treat your chronic pain? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies)
2. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects)
3. What factors do you take into account when making decisions about selecting a course of treatment?
4. How well does your current treatment regimen manage your chronic pain? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities)
5. What are the most significant downsides to your current treatments, and how do they affect your daily life?
6. What challenges or barriers to accessing or using medical treatments for chronic pain have you or do you encounter?
7. What specific things would you look for in an ideal treatment for your chronic pain?

 

 

Filed under: General Problems