The Perils Of Ignoring Patients In Drug Development

Lack of early patient involvement in trial design can lead to burdensome studies, inappropriate endpoints, and in some cases clinical failure, delegates heard at a recent regulatory meeting.

Patients and trial — Early patient involvement in drug development can help secure success • Source: Shutterstock

Patient involvement in drug development from the early stages is no longer a “nice to have” but is essential for securing clinical success. Not adequately involving patients can lead to selection of the wrong endpoints, erroneous assumptions about unmet need and trials that are too burdensome for patients to take part in, according to Jo Dewhurst, director of therapeutic expertise at contract research organization ICON.

“Regulators are always telling developers to engage with them as soon as possible, but the same principle needs to be...