- The Food and Drug Administration (FDA) has published a call for nominations for their newly-minted Patient Engagement Collaborative (PEC), which will consist of an outside group of patients and caregivers offering their input into FDA’s patient-centricity efforts.
FDA created the PEC in response to public comment on the Food and Drug Administration Safety and Innovation Act (FDASIA), in which stakeholders recommended FDA create a separate arm to inform patient engagement activities across the Administration.
The FDA’s Clinical Trials Transformation Initiative will coordinate the PEC nomination process, which is taking place now through January 29, 2018.
Nominees should fit the following criteria:
- Patients who have personal disease experience
- Caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have personal disease experience through this caregiver role
- Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience
The PEC will not necessarily comment on specific medical devices or drugs under development. Instead, the body will help shape the patient engagement initiatives that in turn will impact the development process, FDA explained.
These activities may include streamlining patient engagement, increasing transparency and education, boosting communication, creating new patient engagement strategies, and building new models for patient collaboration with medical product development partners.
On the whole, these activities should build on previous FDA efforts to improve patient engagement, including the Patient Focused Drug Development meetings and the Patient Preference Initiative.
The FDA’s Patient Affairs Staff (PAS) will lead the new collaborative, working to establish a functioning system that collects all patient and stakeholder voices. PAS will guide the PEC in the following areas:
- Creating and aiding public and private patient engagement partnerships
- Coordinating programs to leverage industry-wide best practices in patient engagement
- Fostering cross-center collaborations and adhering to Administration standards in patient engagement
- Building a patient engagement information database
- Establishing a triage protocol for patient engagement inquiries
- Hosting a central point of entry for patients and patient advocates
- Supporting external FDA communication relating to patient engagement activities
The PEC was modeled after a similar venture in Europe, the FDA said. The European Medicines Agency’s Patients’ and Consumers’ Working Party (PCWP) assists in enhancing the organization’s relationships with patients.
The PCWP has allowed patients to review medication instructions to test patient understanding, determined patient and advocate eligibility for patient engagement activities, and engaged patients as experts in regulatory activities. Ideally, PEC members will accomplish similar items.
This initiative aligns with other patient-centered activities that have been taking place at FDA as of late. In October 2017, FDA held its first Patient Engagement Advisory Committee (PEAC) meeting. This meeting began discussions regarding how FDA will regulate both developmental medications and medical devices, according to FDA Commissioner Scott Gottlieb, MD.
“The FDA’s work requires us to establish objective, consistent criteria on which we base our decisions,” Gottlieb wrote in a statement prior to the event. “But ultimately, the criteria we use to judge benefit and risk turn on the parameters that matter to patients. Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important.”
Although FDA did not release meeting notes, Gottlieb discussed some meeting goals prior to the event.
Foremost, the PEAC sought to assess patient perspectives on clinical trial design, recruitment, and results dissemination. The group was set to discuss elements such as outcomes data and patient-generated health data, two significant topics surrounding clinical trial development, Gottlieb said.
Additionally, the Committee discussed the use of patient preference data, which will be extremely helpful during the device development period.
Combined, these efforts are targeted at making FDA more patient centric and ensuring patients and other key stakeholders are fully involved in the creation of the medications and other medical tools patients will eventually use.