Successful patient recruitment and retention is only possible when you truly understand your patient population; when you view the protocol from the patient’s perspective. During this presentation we will focus on a paediatric rare disease case study and explore how Pfizer has been working in close collaboration with patients to bring their voice into the design, planning and execution of the study and its associated recruitment/retention activities.

• Paediatric rare disease case study
• Successful patient recruitment and retention planning
• Establishing early patient and caregiver engagement regarding protocol design
• Collaborating with patient groups to gain insights into operational plans and recruitment/retention activities
• Conducting paediatric protocol simulations to understand trial burden
• Continuing close engagement and collaboration with patient communities throughout the study duration

One of the known tools for fueling recruitment and retention is focused interaction with site staff during trial conduct. Here large mid-study investigator meetings can be an option. Investigator meetings, presenting trial results, can also positively affect site recruitment for future trials. However, face to face meetings are time consuming and costly.  An alternative way to achieve these goals is via virtual meetings. They enable multiple participants to join without increased cost and introduce a huge flexibility in meeting time and place. In this presentation different types of virtual meetings – as well as learnings – will be shared of how to conduct a virtual investigator/results meeting.

• Recruitment and Retention
• Retaining sites for future trials
• Virtual meetings – what are the options?
• Pro’s and con’s
• Learnings and practical tips

By definition, Non- Interventional Studies (NIS) should be less burdensome then interventional study for patients. Nonetheless, patient’s experience on participating to NIS is still to be improved from the consent form signature up to the study end experience. These studies are also great opportunity to learn more from patients and to shape real medical practice with patients for patients to improve their quality of life. This is a well-understood strategic objective of the ClinOPs medical affairs team that started their transition to more patient-centric program. Our case study will share the goal of one NIS that is not only to gather information from a real-life cohort, it also aims at a better understanding of disease management impact on patients’ quality of life, assessed through patient and physician questionnaire. A subsequent patient workshop was planned to ensure the collection of patients’ advices on materials needed to help study patients and future patients understand the questionnaire setting concept and process. We propose to share with you the setup of this workshop from patient engagement up to the concrete deliverables further to the patient workshop.

• Patient centricity at Ipsen: work for patients with patients to help improve patient outcomes
• Patient centricity as a mindset and process
• Real-world study and patient engagement
• Listening and co-creation with patients on supporting tools
• Patient workshop setup, conduct and lessons learned

Virtual trials are gaining popularity in the pharmaceutical world and AstraZeneca is evaluating this innovative approach for the benefit of patients and to improve recruitment/retention in clinical trials. During this session, we will share with the attendees some of our recent learnings from a paediatric study.

• Hybrid Virtual Trial
• Paediatric
• Lessons learned