A clinical trial aimed at evaluating the efficacy of a nutritional supplement in improving perinatal mood and stress was due to start in Singapore when the COVID-19 crisis hit. A fully decentralized operational model was then adopted to mitigate the impact of the strict lockdown measures. The fully decentralized model leveraged digital advertisement and recruitment modalities, electronic questionnaires, virtual visits, and the integration of a connected sensor for digital endpoint collection. Remarkably, there was a 33% acceleration in recruitment, and data capture achieved 100% completeness. Additionally, modeling the environmental impact of the decentralized operational model versus a site-centric model showed that decentralization decreased the impact on global warming by 61%. Furthermore, in all other environmental aspects, the decentralized model exhibited an impact that was between 23 to 80 times lower when compared to the site-centric one.

Patient centricity is at the core of trial design. New technology and digital tools, better informed patients, hybrid/decentralized trials, and a more collaborative relationship between sponsors and trial volunteers are all driving this change in tandem. So, how do you improved your trials, your enrollment planning, and your patient engagement strategy in a digital world?

To draw on the experience and learning today of best practices for Decentralised Clinical Trial (DCT) approaches in Europe and to think beyond just DCTs we are working on an integrated innovation and transformation roadmap for patients. This talk will provide insights into the opportunities and challenges, and give an update on our experience to date.

The clinical research enterprise is more patient-centric than it has ever been and requires greater understanding of the factors that allow for increased participation and retention of volunteer patient-participants. This presentation will provide session participants with important takeaways resulting from peer-reviewed research. The audience will gain an understanding of: Relationship between diversity in patient volunteer participation, and diversity among the clinical research workforce; Current state of racial, ethnic, and gender in representation in clinical research volunteer participation at clinical research sites in North America, Europe, and ROW; and Potential workforce-related strategies to increase patient engagement and retention.

Roche/Genentech prioritizes inclusive research to increase the representation of historically under-studied and under-represented patients, with a focus on diseases that disproportionately or differentially affect patients across races/ethnicities. This discussion will share insights from ongoing efforts to advance inclusive research, with a focus on operational tactics that support the recruitment of minority and special populations, to ensure that the populations which these new treatments will serve are represented in our clinical trials.

Stakeholders involved in drug development, evaluation, and clinical use are presently calling for evidence-based insights into ways for assessing and including patients’ preferences in a meaningful and systematic manner. Widespread implementation of robustly designed patient involvement methods in all steps of the process, from drug development to treatment and surveillance, will amplify patients’ unique voices in the medicinal product life cycle. This presentation will offer insights into patient preferences and participation, preference exploration, and elicitation methods for use in clinical trial protocol development and submissions to regulators and HTA bodies. Methodological learnings proposed ways, and present challenges for systematically integrating preference studies in medical research and practice, complementing existing methods, and fostering targeted multi-stakeholder discussions and internationally accepted recommendations and guidelines.