In May 2018, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), invited the Life Raft Group to the ISPOR 10th Patient Representatives Roundtable during the ISPOR 2018 conference in Baltimore, MD. Dr. Yu Wang, representing the LRG, joined representatives from 20 other patient advocacy groups along with representatives from academic research institutes, government agencies, insurance companies, and pharmaceutical companies, to discuss important topics around patient reported data, patient initiatives, and research.
As the FDA recently announced the planned development of four guidances implementing their new patient experience data program, we shared our thoughts on re-defining patient engagement in research and how to measure meaningful patient engagement. The FDA is working on an effort to include “meaningful” patient experience data in its decisions on new drug approvals and post-marketing surveillance. We discussed which data should be collected, how it should be collected, and how it should be submitted. The attendees also had a data review on regulatory approval and discussed what type of patient-provided information are/are not valued by decision makers.
Information on the first guidance can be found here.
For patient initiatives, ISPOR presented their partnership with IMI PARADIGM project, co-led by the European Patients’ Forum and EFPIA. PARADIGM’s mission is to provide a unique framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement. The objective is to develop much needed processes and tools for three key decision-making points: research priority setting, design of clinical trials and early dialogue.
At the end of this roundtable meeting, ISPOR and the National Health Council announced the Research Matchmaking Project. Acknowledging the value within the real-world evidence from these patient advocate groups such as the LRG, this project helps in establishing collaborations between pro bono data scientists and patient organizations. Such one-on-one matchmaking tends to provide technical assistance to the patient groups in research project initiation, data analysis, and statistics.
The conference provided valuable information for advocacy organizations like the LRG, who are invested in the power of patient data and real-world evidence.