Dyan Bryson from Inspired Health Strategies joined me for an in-depth discussion around Patient-Focused Drug Development, best practices for designing diverse and patient-centric trials, and how to use technology to improve the patient experience. We also dived into virtual clinical trials, tips for building and enhancing patient advocacy, adherence, and education programs, and much more!
Here is a sneak peek of our conversation:
Q: Can you talk a little bit about the concept of Patient-Focused Drug Development or Patient-Focused Medicines Development? What does this all mean and why should we all be listening to this?
A: You hit upon my favorite topic. The FDA has issued guidance a few years ago, patient-focused drug development, and then in Europe, there is a movement: patient-focused medicines development. They’re both after the same thing: ensuring that the patient is heard and participates not just in clinical trials but also in drug development in a meaningful way, from pre-IND all the way through to commercialization. This does not mean that just because someone is participating in a clinical trial that it would be enough, that’s not enough. That’s what you’re going to have anyway. What they’re really looking at is getting input before the protocol is even built.
Only about 11.3% of all clinical trials are completed every year. Usually, they are not completed because they can’t get the recruitment and the protocols are just too difficult. If you’re able to build a protocol around a person rather than the drug therapy, you’re going to have better luck at getting someone to complete that trial.
I had been practicing these principles before the FDA had even issued guidance and I had a friend who let me know that the FDA was going to have a meeting about this. I was going to stay home and do the webinar and she said “Nope, you need to get yourself down to DC and be in the room. I am so glad that she did, because I was there when the FDA finally said, “Movements are not happening enough, we’re going to issue guidance to push the industry along.” It probably wasn’t until I was on the train on the way home that I realized what that really meant.
I haven’t seen the activity that I thought I would see and I think it’s because the industry does not know exactly how to apply this. I remember working with a clinical operations team and trying to get them to get patient input early and they told me point-blank: “Why? They don’t have anything to offer me. They’re not going to be able to guide me on anything,” and that was just 5 or 6 years ago. That attitude has slowly changed but that’s because I think there is a movement out there and a lot of the work that the PFMD team has done to help really drive momentum, as well as issuing a training program to help people understand how to apply.
I think the industry’s changing, it’s getting there but it’s not quite there yet…
For more of our discussion, you can watch the whole Fireside Chat with Dyan Bryson, or listen to the podcast version, below.
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