On April 13, Real4Reg hosted its second Patients Workshop entitled “Real-World Data and Patients: Breaking the Ice”. This event had an audience of over 100 people and even though patients and patients’ organisation representatives were a significant portion of the attendees, the workshop also showed to be interesting for pharmacists, nurses, regulatory affairs and pharmacovigilance specialists, researchers, data scientists, and statisticians.
The session’s speakers were Martin Russek (BfArM) and Erlyn Macarayan (PatientsLikeMe).
During the first session “Real-World Data (RWD): Patient Perspectives and Applications in Healthcare” some results of Real4Reg’s latest scientific publication “Key Stakeholders’ Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process – Results of an EU-Wide Survey” were addressed. Martin discussed the patients’ opinions and perspectives regarding the current use, future impact, and willingness of these stakeholders to share their health-related data. In addition, he also gave examples of how RWD can be useful for multiple healthcare areas, namely academic research, public health, regulatory agencies, and industry.
The second presentation “PatientsLikeMe: A Platform for RWD Sharing and Patients Engagement” was delivered by Erlyn Macarayan and the main goal was to present the PatientsLikeMe platform, which allows patients to share their health-related data and engage in forums with other people under the same circumstances. During this session, the type of data that patients can share, the different website sections, the reported benefits or data privacy aspects, were some of the addressed topics.
After Martin’s and Erlyn’s presentations, a discussion with Margarida Oliveira (INFARMED, I.P.) and Dirk De Valck (EUpALS) was moderated by Rebecca Moore (EIWH). Regarding Martin’s presentation, the questions revolved around ways to encourage patients to share their RWD and the benefits of this initiative to regulatory decision-making and health technology assessment (HTA). On the other hand, Erlyn’s presentation raised questions about the importance of online patient communities and the future of patient-driven data sharing platforms. At the end of the event, the audience was invited to ask questions to the speakers. The attendees were interested in topics related to ethical/privacy issues and representativeness when collecting RWD, the role of physicians in encouraging patients to share their health-related data, and how engaged patients are in these patient-driven data sharing platforms.
Recordings and presentations
RWD: Patient Perspectives and Applications in Healthcare
Martin Russek (BfArM)
PatientsLikeMe: A Platform for RWD Sharing and Patients Engagement
Erlyn Macarayan (PatientsLikeMe)
We Need Your Help for Real4Reg’s Final Symposium!
At the end of the year, Real4Reg will have its Final Symposium, where the project’s main results will be presented. Since all stakeholders are important, a patient dedicated session will take place and we need your help to choose the theme that you would be most interested in seeing addressed. To do that, please scan the QR code above or go to mentimeter.com and insert the code 5196 8269 and vote on your preferred option.
Key takeaways:
- Keywords: data privacy/security, representativeness, collaboration, training, patient involvement, decision-making
- Patient involvement in regulatory decision-making and HTA through RWD sharing is crucial, since information obtained from clinical trials is limited and nonrepresentative of the majority of the population. However, patients need to have more training to understand the concept and the potential benefits.
- RWD sharing is especially important in diseases with lack of treatment options and/or high mortality rates, for example amyotrophic lateral sclerosis (ALS). These patients are usually very willing to share their health-related data, allowing a direct understanding of their experience and day-to-day life with their condition.
- Patient main concerns when sharing their health-related data include data privacy/ethics issues and perception of lack of benefits. Addressing their worries in a clear and accessible way is extremely important, requiring a close collaboration between experts and patient organisations.
- Utilisation of patient-driven data sharing platforms helps patients to manage their symptoms, adjust to their new condition, and improves conversations with healthcare professionals. Apart from the medical benefits, interacting with people under the same circumstances helps patients to feel more seen and understood, creating a community that allows the establishment of relationships that are not only based on sharing a disease.