{"id":22543,"date":"2023-02-01T13:14:51","date_gmt":"2023-02-01T18:14:51","guid":{"rendered":"https:\/\/participatorymedicine.org\/epatients\/?p=22543"},"modified":"2023-02-01T13:14:51","modified_gmt":"2023-02-01T18:14:51","slug":"patients-and-industry-starting-our-new-life-together-in-2023","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2023\/02\/patients-and-industry-starting-our-new-life-together-in-2023.html","title":{"rendered":"Patients and Industry: Starting Our New Life Together in 2023"},"content":{"rendered":"

Flash back to my article for the Society for Participatory Medicine last year: Let\u2019s Save the Date and Make Patient Engagement Official in 2022.<\/a> I\u2019m here to deliver some great news: we tied the knot! By the power vested in clinical research, the FDA now pronounces us patient and industry. You may now kiss the cancer survivor.<\/p>\n

The FDA issued a series of four patient-focused drug development (PFDD) guidance documents<\/a> which outline how patient co-design needs to successfully happen. Based off of the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I, our officiant provides counsel on the what <\/strong>(comprehensive and representative patient input), the why <\/strong>(because patients are the best subject matter experts of our lived conditions and have a direct stake in drug development and in the outcome of the FDA review process for new drugs), and the how<\/strong> (methods for eliciting information from individuals, thus gathering information about what aspects of symptoms, impacts of our disease, and other issues are important to patients).<\/p>\n

Global regulatory bodies took note, as similar direction was put forth by the EMA under the ICH<\/a>. Patient insights will go from a \u201cnice to have\u201d to a \u201cneed to have\u201d to a \u201cmust have.\u201d Our honeymoon commenced in April with what some pharmaceutical sponsors refer to as a \u201cmandate\u201d to show proof of a diversity, equity, and inclusion plan<\/a> \u201cas soon as practical\u201d in the new drug application process, further solidified by the passage of the omnibus spending package<\/a> at the end of 2022. This activity sent pharma and biotech companies scrambling to hire DE&I officers and related patient advocacy, engagement, and experience personnel as they came to terms with this foreign notion of actually collaborating with real, live patients. We patients rejoiced at our day of reckoning, finally getting a seat at the table to have our representative and collective voices heard by decision makers. I\u2019m not really sure what\u2019s been happening with PDUFA VI<\/a> the past seven years, but I\u2019m hoping that PFDD activity that took place in 2022 are the new tires needed to get that car out of the shop and back on the road.<\/p>\n

Interestingly, I didn\u2019t observe the same vigor around PFDD from payers and health systems as sponsors, but I\u2019m optimistic they\u2019ll jump on board as key opinion leaders in the drug\/medical product development process, since the healthcare ecosystem is a small world comprised of codependent partners. Power to the patients continued to surge throughout the year, capped off by the ONC with the information blocking\u2019s limitation on the scope of electronic health information (EHI) lifted as of October 6<\/a>, granting patients full real-time access to our medical records, despite 10 major healthcare industry groups\u2019 opposition.<\/p>\n

Just like any marriage is more than its license, patients are wondering how the FDA PFDD guidelines will be enforced. This hasn\u2019t been made clear yet due in part to the fourth and final guidance session on clinical outcome assessment data yet to occur in 2023. After this, patients will anxiously await implementation of the series. Will it be a punishment (such as a delay of a new drug application until proof of concept) or an incentive (such as accelerated approval)? After all of this time and energy expended, it\u2019s only right that patients would be witness to accountability of pharma\/biotech to incorporate our collective voice. Having sat in on some industry meetings between clinical research organizations and study sponsors, I am excited at the patient stakeholder group having equal representation and influence with the operationalization of drug development. Even more so, after listening to medical affairs, regulatory, feasibility, site strategy, data management, procurement, pharmacovigilance, logistics, and risk based monitoring present, I was the one who had the privilege to speak up and tell pharma and biotech the implications that their actions would actually have on living, breathing patient participants, thus helping to break new industry ground.<\/p>\n

Now more than ever, thanks to the FDA taking the plunge with us, patients have proper validation to ensure that trial design has endpoints and outcomes with meaningful use. What good is a walk test if a patient is disabled and unable to walk? What good is progression free survival when a patient just wants a day without pain?<\/p>\n

We did a great job of learning empathy these past two years. So with regulatory blessing, it\u2019s time to transform advocacy into activism with demonstrative patient involvement.<\/p>\n

Stacy Hurt, MHA, MBA works as a Patient Engagement Consultant to represent the consumer perspective in clinical decision making, health IT user experience, and pharma\/biotech drug development. She is currently contracted by Parexel as their first Patient Ambassador. Stacy was named to the Medika Life Top 50 Healthcare Influencers list and regularly advocates and keynotes on how COVID driven innovations such as telehealth and decentralized clinical trials need to remain as permanent options to enhance patient care. Connect with Stacy at<\/em> https:\/\/stacyhurt.net\/<\/em><\/a>.<\/p>\n

\u00a0<\/em>Would you like to see more articles like this?\u00a0 Please consider supporting the Society by joining here: https:\/\/participatorymedicine.org\/memberships\/<\/a>.\u00a0 Thank you!<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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