Patient engagement drives innovation and leads to better retention, trials that meet the needs of patients and faster approvals. Involvement of different types of patients is important, from Patient Organisations, Expert Patients to Lay Patients. There are today clear methods, tools, guidances and best practices available for implementing effective patient engagement. However, many challenges remain in implementing this vision. A clear need for education and training for sponsors on patient involvement has been identified. Resources are also a challenge, as changing the current procedures and a paradigm shift does require re-allocation of investment. There is also a need to build strong relationships with the patient community and enhance an open and transparent communication and exchange of information, especially within rare diseases.

Patient-centricity in R&D requires a different mindset and adaptation of ways of working in the pharma industry. Patients are a preferred partner to support this process. This presentation will share how the creation of an expert patient board with different cross-functional teams allows an organization to speed up what is an ever-changing process. The main results, experience, and lessons learned will be shared in this talk.

This talk will focus on learnings of a larger R&D organization to ask, listen, and ACT along the lines “from insights to impact.” We will share examples of how patient voice has shaped protocol design or elements of the study conduct. In addition, we will share how to pilot and scale patient voice across different therapeutic areas – e.g., rare diseases vs. prevalent diseases.

This innovative project by Cancer Research UK has enabled the development of a pioneering app that amplifies the voice of patients and enables researchers to better understand their needs and preferences. This talk will explain why patient feedback is crucial for improving recruitment and engagement in clinical trials, and why now is the right time for this new technology to be incorporated routinely in clinical trials.

A paradigm shift: the role of individual participant data in advancing care options and drug development, commitments to a new mindset, and operational strategies to optimize meaningful, flexible, personalized clinical trial options that strengthen patient alliances and experiences, opportunities to evolve efficiencies, maximize cross-collaboration impact, and accelerate participant data-sharing models to facilitate interoperability of clinical data collection systems and bridge the gap between clinical care and clinical research.

Sanofi will share their clinical operations transformation project, Act4Patients. The overarching goal of A4Pts is to transform and simplify the clinical trial process for our patients and sites. In addition to simplifying for our patients, our other key transformations center on digitizing and automating our data and work, leveraging data and science to make decisions, raising trial awareness, and making trial participation an option for all patients.

Launching a global clinical trial recruitment platform at a large company, like MSD, can be an arduous process. Although difficult, standardizing the way our company brings clinical trial information to our global audience is critical to enhancing clinical trial awareness and education in addition to facilitating recruitment of clinical trials. Through partnership with our local in-country leads it is expanding with localizations incorporating local culture and nuances into each build for our major global markets. The platform enables new clinical trials to launch digital platforms and awareness campaigns with efficiency significantly reducing resource effort without sacrificing quality and compliance. MSD is effectively enabling flexible options for recruitment via this digital resource.

Nestlé has led a fully decentralized study on ketogenic treatment for migraines. All aspects of the trial were performed remotely including recruitment, screening, consent and study visits. Whether it's due to advancement in digital technologies, COVID-19 pandemic or increased focus on a patient-centric approach, decentralized clinical studies are becoming more common. However some sponsors still hesitate to implement fully decentralized studies due to the complexity or inexperience in this approach. We wish to share our first experience in conducting a decentralized study to help other sponsors understand some of the operational considerations and implications.