Reflections on the Evolution of Patient Engagement in Drug Development.

This article presents the author's opinion on the past and present state of the Patient Engagement movement and discusses ways in which the movement will need to change and evolve if it is to become viable and standard practice in drug development. For most of the past decade, drug development sponsors-both government-funded and industry-funded research-have been aspirational in their support of Patient Engagement initiatives. New frameworks and guidelines have been proposed and developed, and a wide variety of initiatives have been planned and piloted. Many factors have facilitated a tentative and experimental posture-these include internal resistance to modifying legacy practices and processes; insufficient funding and staff to implement and manage initiatives; lack of clarity from regulatory and health authorities; and uncertainty around expected impact and return on investment. Recently, research sponsors have begun restructuring their Patient Engagement capabilities and they have been seeking more concrete return on engagement measures. These developments signal that the Patient Engagement movement has entered a new phase, becoming more rigorous as it seeks to balance ethical and moral obligations with scientific and business imperatives.