DIA 2018 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-704-L04-P; CME 1.25; IACET 1.25; RN 1.25

Meaningful engagement with patients is planned with a purpose, and as it is more fully integrated into the medical product life cycle, measuring its impact is increasingly important. Patients, sponsors, and regulators want to know if their expected outcomes have been achieved. How to measure the impact of patient engagement depends on your viewpoint. In this session, stakeholders discuss their perspectives on the outcomes they might expect from patient engagement and what types of measures can signal achievement. A case example of evaluating the impact of a patient engagement effort from the dual perspectives of patient satisfaction and clinical development deliverables will be examined.

Learning Objectives

Describe the relationship of expected outcomes of patient engagement to impact measurements; Identify one outcome of patient engagement that is important to each key stakeholder; Discuss possible measures to assess the impact of patient engagement from the perspective of each key stakeholder.

Chair

Roslyn F Schneider

Speaker

Thank You! The Power of Gratitude to Improve Clinical Development Quality
Mary Stober Murray, MBA

Patient Engagement
Ellen Coleman, MPH, MS

Patient Perspective
Suzanne Schrandt, JD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-612-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will demonstrate how advocacy groups can be effectively leveraged for protocol design and in capturing valuable information from standard clinical practice-information that is real-world evidence driven and much needed to develop effective clinical trials.

Learning Objectives

Discuss the importance of using advocacy groups to provide experiences in the real word setting outside of clinical trials that can help understand a disease and develop drugs more effectively; Distinguish the type of information that can be learned from these groups in real world evidence that can influence the development of better medications.

Chair

Shazia Ahmad

Speaker

Panelist
Isabelle Lousada, MA

Panelist
Mary Dunkle

Panelist
Nadia Bodkin

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-627-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session outlines the key issues in maintaining and maximizing patient engagement at all stages of the development of PRO and ePRO measures, with examples drawn from our experience of developing PRO measures. Recommendations are made regarding the most appropriate qualitative and quantitative approaches and a framework suggested for quantifying the degree of patient engagement during the multiple stages of scale development.

Learning Objectives

Recognize the opportunities for patient engagement through all stages of PRO development; Evaluate the degree of meaningful patient engagement in PRO development.

Chair

Sarah Clifford, PhD, MSc

Speaker

Ways in Which Patient and Caregiver Recorded Outcomes and Assessments Will Affect Regulators, Industry, and Patients and Payers in the Coming Years
Christine McSherry, BSN, RN

Patient Affairs Perspective
Michele Rhee, MBA, MPH

Clinical Outcomes
Alison M. Skrinar

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-628-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include examples of enhanced patient registry design and implementation by bringing together diverse stakeholders, including industry, regulators, researchers, clinicians, patients, families, and patient advocacy groups. Patient engagement is included at each stage of the process.

Learning Objectives

Describe ways in which patient engagement can facilitate development of registry governance to satisfy multiple stakeholder priorities; Identify at least three methods used to involve and align multiple stakeholders in registry design and governance; Discuss challenges of designing registries for rare disorders and ways to help address such challenges.

Chair

Steven L. Roberds, PhD

Speaker

United We Stand: How Can Patients and Other Stakeholders Develop Registries to Speed up Research into Rare Diseases?
Stella Blackburn

Patient Registry Data Governance: Considering the Priorities of a Diverse Group of Stakeholders
Kate Avery, MPH

EMA Perspective
Tânia Teixeira, PharmD

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-662-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this session, participants will hear several recent examples of how to best engage with different patient communities with respect to clinical trial design.

Learning Objectives

Discuss examples of how to best engage with different patient communities with respect to clinical trial design.

Chair

Scott Schliebner, MPH

Speaker

Nothing About Us, Without Us: Best Practices for Engaging With the Rare Disease Patient Community
Scott Schliebner, MPH

Enrollment: Using Patient Advocacy Groups to Design a Better Trial and Manage Studies in Rare Diseases
Bruce Wynne, PharmD

Early Engagement with the Kabuki Syndrome Patient Community to Understand Clinical Phenotype and Unmet Needs
Deborah Hartman, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-691-L04-P; CME 1.25; IACET 1.25; RN 1.25

As organizations involve patients, caregivers, and other untapped advisors in the design of clinical trials, questions exist about how best to incorporate the perspectives of these audiences and validate their contributions. Panelists will discuss how organizations are integrating these advisors in drug development.

Learning Objectives

Describe the advantages, practical difficulties, and unanswered questions with involving children, young adults, parents, siblings, partners and other untapped advisors in the clinical development process.

Chair

Jennifer Helfer

Speaker

2017-2018 National Rare Diseases Caregiver Survey Findings
Grace Grace Whiting, JD

Establishing a European Network of Young Persons Advisory Groups to Increase the Involvement in Pediatric Clinical Research
Begonya Nafria Escalera, MEd

What's Love Got to Do with It? Illuminating the Caregiver Treatment Journey
Ann M Moravick