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DIA 2018 Global Annual Meeting
From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design
Andrea Lukes, MD, MHS
- Chief Medical Officer
- Health Decisions, Inc., United States
Too often sponsors resort to obtaining input from their most important stakeholder, the patient, only after their study is not enrolling to plan. Improving the quality of health outcomes, the goal of our collective efforts, can only happen if we keep those receiving our treatments involved in the life of the process. Led by a practicing physician, this session will provide real life examples of effective collaboration with advocacy groups, sites, and CROs to inform and help develop a protocol that be of interest to and will benefit the patient.
Learning Objective : Describe best practices for obtaining and incorporating input from key stakeholders in protocol design; Discuss strategies for collaborating with advocacy groups; Identify protocol development best practices including template creation, facilitating review, and finalization strategies.
Best Ways to Partner with Advocacy Group: From a CRO Perspective
Clint Dart, MS
- Senior Director, Biometrics
- Health Decisions, United States
The Advocacy Group's Voice
Michelle Witkop, DrSc
- Head of Research
- National Hemophilia Foundation, United States