Highlights from the 2nd MELISSA Annual Meeting: Advancing Towards the Clinical Trial and The Relevance of Patient-Centric Engagement

Some weeks after our successful 2nd Annual MELISSA Meeting in Athens (3rd-4th of June, 2024), it is time to reflect on the key takeaways. The unique opportunity of having MELISSA scientists, developers, clinicians and patient representatives sitting all together in the same room marked a significant stride for our upcoming clinical trial. Here's a recap of the key highlights:

Intensified Preparation for Clinical Trials
The meeting underscored the current intense phase of preparation for the MELISSA clinical trial application. Chaired by WP4 leader NOH, sessions focused on the timeline presentation, including the formation of a dedicated coordination group among the clinical sites and the rigorous preparation of all necessary paperwork such as ethics and regulatory documents.
In addition to the MELISSA study, an observational study (EDUCATE) illustrated by UM will be run in parallel to quantify health literacy and numeracy among people with type 1 and type 2 on intensive insulin treatment. Furthermore, potential associations between health literacy and numeracy with other factors, such as glycaemic control, health behaviours, patient-reported outcomes will be investigated.

Advancements in the MELISSA Mobile Application
Significant progress has been made on the MELISSA mobile application, which will be used by the PwD during the clinical trial. Updates on development and testing were shared, along with discussions on the use of sensors and receivers. These technological advancements are set to enhance data collection and patient monitoring throughout the trial. A demonstration of the app, presented by WP2 leader DEBIOTECH, has been shown during the meeting and the main features have been discussed with the partners.

Interconnected Efforts: App, Clinical Trial, and Patient Perspectives
An insightful session was held for ensuring the major alignment between the scientists and developers of the App (WP2), the clinicians involved in clinical trial design (WP3 and WP4), and the members Patients Advisors Committee (PAC). Relevant decisions were achieved regarding the trial design and type, including patient visit schedules and logistics. A kick-off workshop for user interface design will be conducted with the Patients Advisors Committee (PAC) members during the summer, ensuring the app meets user needs effectively.

Empowering Patient Contribution and Engagement
Patient involvement was a focal point of the meeting. In multiple sessions, PAC members were invited to provide their vision and suggestions. Carmen Hurtado, Team Leader of Partner Breakthrough T1D (formerly JDRF), emphasized their critical role in the project, noting, “Patients involvement is something recent. Until 10 years ago, the research happens for the patients. Recently, we have reached a point where research happened with or by the patients”. To support the benefit of patients’ involvement for the project, Carmen cited as an example a study showing that drugs developed with patient-centric designs have a 20% higher chance of being launched and shorter recruitment times for clinical trial.

Patient engagement offers a practical solution to alleviate many of the frustrations researchers encounter when striving to create impactful research that enhances patient care. For this purpose, the benefit of a direct contact between scientists and patients was highlighted. Following discussions have been centered on the patients’ support for defined aspects of the project agenda and the importance for the researcher to set clear expectations. In MELISSA, active engagement was evident as the PAC has been involved in shaping all Work Packages (Fig.1), ensuring comprehensive patient representation. Additionally, active patient involvement in dissemination efforts is increasing the project’s visibility and impact. During the meeting, participants completed a live questionnaire on barriers and facilitators in patient recruitment, emphasizing the importance of using local languages.

The meeting concluded with a renewed commitment to integrating patient feedback and advancing our clinical trial preparations. The enthusiasm and collaborative spirit displayed by all participants promise an exciting year ahead for the MELISSA Project!

Stay tuned for more updates!

Figure 1: Engagement of PAC in shaping MELISSA research, with active contribution in all WPs.