Patient Input into Trial Design – what can protocol authors do to help? – EDG

Incorporating patient input into the trial design/protocol has been shown to not only lead to more successful trials (with fewer dropouts) but also completed more quickly and are more cost-effective than those lacking a patient-centric approach. Patient-centric designs can include patient advocacy groups, decentralization of trial activities, and reducing participant burden. For many Sponsors, the “who, what, when, where, and how” to engage patients remains an obstacle to adoption and one that is often left until it is too late to materially impact the trial design or protocol. In this Expert Discussion Group, we will discuss different ways that patient input can be included into trial design and how medical writers can support patient-centricity during the protocol development stage. Covered topics will include common methods for patient input, direct and indirect approaches to encourage patient input, and future perspectives that promote adoption.

Participant profile: Expert Discussion Groups (EDGs) are group discussions led by a moderator/moderators, and the moderators will pose 2-3 questions ahead of the discussion on one topic to lead the discussion or to bring the discussion back to topic. There will be a max of 10 attendees, and we ask the moderators to set experience levels to keep the discussion standards and the level high. These sessions will be 1.5 to 2 hours.