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Sunday, June 24 • 8:30am - 12:00pm
#22: Protocol Co-Design with Patients and Advocates

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Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-18-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

This course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates. Following a brief introduction outlining the benefits of interactive activities with multiple stakeholders, you will engage in several activities:
  • Protocol red lining (individual/partner activity)
  • Design your own protocol (small group activity)
  • Walk the protocol (large group activity)
The first activity asks you to react to a draft protocol individually. You will then share your reactions with a partner representing a different stakeholder group. The second activity encourages collaboration among multiple stakeholders as table teams work to design a protocol that meets the needs of all stakeholders. The third and final activity will have the entire group reacting individually to a sample protocol (represented by posters on the wall), then discuss their reactions and seek consensus. Each activity will be debriefed to not only assess the experience, but to discuss how a similar activity might be applied to your needs. We will conclude by presenting a case-study that outlines the successful application of these methods for trial design. These exercises were designed by clinicians, instructional designers, and experts in patient literacy. They have been used successfully in numerous workshop settings to obtain input on protocol design features and trial recruitment and retention methods. Feedback on the experience from past participants has been very positive. It is our hope that you will leave the workshop with an understanding of how these types of exercises can be designed and executed to encourage collaboration and to design clinical trials that meet the needs of all stakeholders. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for individuals responsible for clinical trial design and protocol development; clinical trials operations professionals; advocacy leaders who wish to collaborate with trial sponsors; CRO professionals; patient engagement professionals; advocacy engagement professionals

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate valuable and detailed input from patients and advocates on clinical trial design
  • Design patient interactions that encourage collaboration among patients, sponsors, and advocacy groups
  • Critique clinical trials to ensure they meet the needs of all stakeholders

avatar for Kelly Franchetti

Kelly Franchetti

Vice President, Global Head Patient Insights and Engagement, ICON plc
Kelly Franchetti has a diverse background comprised of nursing, patient advocacy and clinical research. This broad range of experiences gives her a unique view of patients’ and caregiver’s perspectives in the realm of disease management and treatment. As a critical care nurse... Read More →

Marsha Jones

Director, Pharmacovigilance, Mapi

Sunday June 24, 2018 8:30am - 12:00pm EDT
Room 159 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  Short Course, Tutorial