Selection for the FDA Patient Engagement Collaborative
I was ill last December following a surgery that had gone badly. It was my second time in the hospital within two weeks, and the recovery seemed a long way away. That was when I saw it. It was a notice that the FDA would be accepting applications for something called the Patient Engagement Collaborative (PEC). I was intrigued, but honestly, I was too ill even to consider completion of an application.
Then in late January a colleague contacted me and asked if I had thought about applying. We discussed my situation, and why I had set it aside. We also talked about the selection process and the fact that there was little on time to apply. After weighing the pros and cons, and discussing the commitment if selected with Sheryl, I decided to apply.
Preparing the application
My first task was to familiarize myself with the functions of the PEC. It seemed that the intent is to make the PEC a patient sounding board for the FDA. But this sounding board will not be about medications or devices. This group is designed to be the sounding board for ways to better involve patients in the FDA decision process. That mission appealed to me.
My next step was to gather endorsements. The application required each applicant to be endorsed by at least one patient organization. I contacted six organizations and received letters from four organizations and one individual. The sixth contact was out of town, and he could not authorize an endorsement without more discussion within the organization. Given the timeline for submission, it was impossible to get the endorsement in a timely fashion. I received two endorsements from the arthritis community and three from the diabetes community. The most influential endorsement I received came from the Arthritis Association.
With the endorsements secured and my part of the application completed, I sent it off in late January. Then I waited. In April I received a note saying they had received my application. Then in late May, I was invited to participate in a telephone interview.
In late June I was asked to submit a list of industry contacts that might be considered a conflict of interest. I had a few potential conflicts of interest and was as transparent as possible. A week later I was informed that I had been selected for an initial two-year term. Half of the group was given a two-year term and the other half a three-year term. Each term may be extended once for three years. The two and three-year terms were decided by lot.
My commitment for two years is to meet with the group each month via telephone and twice per year in person. The first meeting is scheduled for August 2018 in Washington. The meetings will be conducted by an appointed administrator from Duke University Clinical Trials Transformation Initiative (CTTI). You can read the press release from CTTI. I do not know anyone else who was selected to serve, meaning our first meeting ought to be interesting as we work to get to know each other and form a working relationship.
I am excited and humbled to be chosen to be part of this group. As we in the RA community advocate for ways to increase the pool of options to treat RA, and other Rheumatic conditions I will be cognizant of making recommendations that if adopted will improve access to the medications and devices we need to survive.
I was selected to represent the broader community, and that is what I hope to do starting in August in Washington. Please wish me well as I embark upon a new form of advocacy for Diabetes, RA, and the broader autoimmune community.
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