Patient-Focused Drug Development (PFDD)
Based on the 21st Century Cures Act the FDA has issued guidance to help us better engage with patient, caregivers, and families to produce improved outcomes..
The guidance simply says “patients should be involved with drug development in a meaningful way from pre-IND through commercialization
For years, we at IHS have been touting the value of getting patient insights early to inform building protocols with endpoints meaningful to patients and families, not just researchers. Now, the FDA is asking that you do just that.
There is a greater expectation that you will follow what happens with your brand in the real world. Your clinical trials have been performed in sterile, vacuum-sealed environments. What happens when people take your drugs in their real lives? The adverse events you have shied away from collecting can now be seen as early warning signs you can use to inform your business decisions. We encourage you to collect all the data you possibly can to make the best decisions possible for both the patients and your business.
What can I do if my drug is already in clinical trials? Going to the IRB to change things takes time, effort and money - we don't have any of that to waste.
You can easily collect parallel data via the myriad of patient-focused communities. You can engage with patient advocacy groups to develop market research instruments to gather behavioral data. Certainly, this data will not be coming from the clinical trial participants but you will get data to help inform business decisions as you prepare for launch. The real deal is, do not plan your launch in a vacuum. Build ongoing opportunities to learn from the patients, caregivers, and families who manage the disease your drug targets on a daily basis. They are the experts!
It depends on the segment of the business that you are in, but it certainly means changes for the entire life sciences industry. Below links to examples illustrating how you do business can change.
That is expected as PFDD demands a change in thinking, that is the real innovation here. Time will tell, though. As the FDA requires NDAs to include this patient experience data, let’s see whose NDA gets rejected due to not including this data. We bet that will be a motivator. In the meantime, you can help your company along by staying informed, avail yourself of the resources on this site and others. This gradual drip drip of information will eventually impact every organization. Face the fact that the life sciences industry is incredibly slow to change. The real innovative companies will get on the bandwagon early.
Well, it is a great start! Kudos to you and your team! Next, ask your self HOW you are collecting this data? Is it via a paper-based questionnaire that is administered at the clinical trial site? Can the questionnaire be updated with information you learn along the way? Can the data be collected in real time? Remember, what we are going for here is to understand better how your drug will impact patients lives in the real-world.
We think so, but only if you listen to the patients , caregivers and families in addition to academia and researchers. We have to learn to value this information we can gain from potential study participants. If you need blood collected or other tests during the clinical trial ask yourself how you can make that collection easier for patients – can it be done though a local center rather than a trip to the study site? The more we take down barriers to study participation the more chances we have at people actually completing a trial. Just because you included travel costs in your protocol does not make things easier on patients. Sure, that covers the costs but what about the inconvienence? How long does the participant have to stay out of work or get child care? How does travel impact the overall health of the participant? The more we think about these things and make amendments to protocols to reduce the barriers the better chance we have at greater study completion. Again, this demands a change in OUR thinking.
In this section we provide links to the freee resources we find so you, too, can take advantage of these resources to learn more. Also, check out our Patient Engagement Resources tab on this site for additional free downloadable resources.
We have experience developing customized training to help your organization to strait to think differently and adapt to PFDD. We can talk about your needs and customize training for you. Every organization is different and demands a different approach. Know that the first thing we will do is work with you to assess where your organization sits on the valuing of PFDD continuum.
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