The FDA has issued guidance to help pharmaceutical and life sciences companies better engage with patients, caregivers and families for healthier outcomes.
With its draft guidance, Patient Focused Drug Development, the FDA encourages the industry to include patients in a meaningful way in drug development — from pre-IND through commercialization. Many pharma manufacturers aren’t fully aware of the implications this guidance will have on their business. As a result, few have made significant progress incorporating the guidance into their culture and operations
Conduent manages healthcare data for government agencies, manufacturers, health plans and providers – giving us the unique ability to support the industry’s efforts to help organizations comply with the requirements of PFDD.
What is the PFDD guidance?
The guidance simply says, “patients should be involved with drug development in a meaningful way from pre-IND through commercialization.”
How will this change how I do business?
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.
How does PFDD change clinical trial execution?
For years, many of us in the industry have been touting the value of getting patient insights early and using them to create protocols with endpoints that are meaningful to patients and families — not just researchers. Now, the FDA is asking that you do just that.
What if my company culture does not consider PFDD a priority?
This is an expected reaction as PFDD demands a change in thinking. But as the FDA begins to require NDAs to include this level of patient experience data, companies will inevitably start to fall in line and make it a priority. In the meantime, you can help your company move progress by staying informed about what needs to be done and when. This gradual trickle of information will eventually impact every organization.
What can I do if my drug is already in clinical trials?
Going to the IRB to change things takes time, effort and money – no one has any of that to waste. You can easily collect parallel data via the myriad of existing, patient-focused communities. You can engage with patient advocacy groups to develop market research instruments to gather behavioral data. Although this data will not be coming from the clinical trial participants, you will gather key data to help inform business decisions as you prepare for launch. It’s critical to build ongoing opportunities to learn from the patients, caregivers and families who manage the disease your drug targets on a daily basis. In the end, they are the experts.
We are already collecting quality of life data within our clinical trial— isn’t that enough?
Well, it is definitely a great start. Kudos to you and your team. The next step is to look at 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, to the most important goal with PFDD is to better understand how your drug will impact patients’ lives in the real world.