Delighted and honoured to have been invited to address the prestigious European Society of Cardiology Congress 2024, the foremost gathering in the field of cardiology worldwide (25k participants). As a member of the ESC Patient Forum and representing AIPI Italian Pulmonary Hypertension Association and the Alliance for Pulmonary Hypertension, I spoke on the vital topic of integrating the patient perspective into future pulmonary hypertension clinical trials.
My aim was to underscore the invaluable knowledge patients bring, derived from firsthand experience with the disease, which can significantly augment the expertise of medical professionals. Increasingly, patients are being recognized as essential contributors across EU institutions, regulatory bodies, scientific societies, academia, research institutes, and the healthcare industry.
Notably, in the realm of pulmonary hypertension, significant strides have been made, including the inclusion of patient representatives in the latest clinical guidelines. Additionally, the establishment of a patient perspective within the World Symposium on Pulmonary Hypertension, the field’s premier scientific event, marks another critical advancement. I was honoured to be a part of both these initiatives.
Despite these gains, patient involvement in research remains limited, as does the utilization of Patient-Reported Outcome Measures (PROMs), valuable tools for capturing the patient experience.
During my presentation, I highlighted key findings from a recent (2022) survey conducted by the European Medicines Agency (EMA), which underscored the critical impact of patient input:
🔹 20% of the scientific advice responses provided by EMA to companies between 2017-2020 were modified following patient input.
🔹 Patient input prompted additional reflection by EMA procedure coordinators in over 50% of cases.
This data compellingly demonstrates that patient involvement should begin early in the drug development process.
I also addressed the current challenges surrounding patient participation in clinical trials and the use of Patient-Reported Outcome Measures (PROMs). In this context, I made some suggestions for future trials:
🔹Enhanced patient information and education: Patient associations can play a pivotal role in improving awareness and understanding of clinical trials, including sharing findings, and about the value of the use of PROMs
🔹Decentralization of trials: Conducting some tests and visits from home or local healthcare facilities can ease the burden on patients.
🔹Use of digital health technologies: Allowing patients to provide data directly from home with wearables or other activity trackers, can streamline the trial process.
These recommendations aim to foster a more patient-centered approach in clinical research, ultimately improving outcomes for all stakeholders involved.
#pulmonaryhypertension #pulmonaryarterialhypertension #PAH
