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Monday, June 25 • 11:00am - 12:00pm
#108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-521-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Andrea Lukes, MD, MHS


Best Ways to Partner with Advocacy Group: From a CRO Perspective
Clint Dart, MS

The Advocacy Group's Voice
Michelle Witkop, DrSc

avatar for Clint Dart

Clint Dart

Senior Director, Biometrics, Health Decisions
Clint is responsible for the oversight of Biometrics (statistics) and Medical Writing at Health Decisions and have over 21 years of clinical trial experience. He is the principle investigator of the statistical and clinical coordinating center that HD runs for the NICHD. He is responsible... Read More →
avatar for Andrea Lukes

Andrea Lukes

Co-Founder, OB/GYN, Carolina Research and Wellness Clinic
Dr. Andrea S. Lukes is a board-certified OB/GYN, a Fellow of The American College of Obstetricians and Gynecologists and an expert on clinical development of women’s health products in indications across the female lifecycle. As the Chief Medical Officer, Dr. Lukes advises Health... Read More →
avatar for Michelle Witkop

Michelle Witkop

Head of Research, National Hemophilia Foundation
As the Head of Research, Dr. Witkop, a Doctor of Nursing Practice, leads the National Hemophilia Foundation’s research initiatives. Previously the lead practitioner at the Northern Regional Bleeding Disorders Center in Traverse City MI, she is the 2015 recipient of the Nurse of... Read More →

Monday June 25, 2018 11:00am - 12:00pm EDT
Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session