DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

Investigators and regulatory agencies find it commonplace to receive protocols with a wide variety of primary and secondary endpoints to demonstrate efficacy for a given disease area. It is also commonplace for a medical writer or clinician to need to reinvent the wheel of endpoints for every new compound. The resulting product is that investigators and regulators receive inconsistent endpoints for similar indications, requiring the interpretive skills of a wizard. We have all gone down the ‘Yellow Brick Road’ of developing protocols and improving our endpoints for a disease area many times. Despite a plethora of research publications with clear descriptions of endpoints, it is common place to begin protocol development with no clear standards of endpoints. Clinical teams involved in protocol development often find that the long circuitous path down the ‘Yellow Brick Road’ is filled with a multitude of choices, missing bricks, potholes and wrong directions. Some of the key inefficiencies in protocol development stem from delays to endpoint finalization and resultant cascade of delays to additional protocol content such as assessments and statistical analyses. Protocol authors, whether medical directors or writers, struggle to achieve clear, consistent endpoints and all wish for ‘Dorothy shoes’ to click together for the right path. Additionally, the common occurrence of endpoint creep translates into significant increases in development costs. This session will provide insights to optimal endpoint and protocol content development required for registration protocols.

Learning Objectives

Describe the approach used to develop primary and secondary endpoints in a therapeutic area.

Chair

Anne B. Cropp, PharmD

Speaker

The ABCs of Writing Effective Clinical Study Protocols
Julia Forjanic Klapproth, PhD