DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-604-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are the experts in their disease and its impact, and across the research enterprise, stakeholders are working to identify how to best leverage this expertise to enhance trial design, conduct, and overall relevance to patients. This session will provide patient, regulator, and industry perspectives on how this goal can be achieved. Speakers will review key FDA, Clinical Trials Transformation Initiative, and sponsor initiatives designed to bring the patient into the conversation as trials are designed, implemented, and their results reviewed. Presenters will discuss challenges faced and offer ideas on how these challenges may be proactively addressed.

Learning Objectives

Discuss key FDA initiatives related to patient engagement and how these may better incorporate the patient perspective into all stages of drug development; State a patient perspective on how patients could be better engaged in trial design and recruitment and learn about a project to facilitate patient engagement and recruitment.

Chair

Jonca C. Bull, MD

Speaker

Patient Perspective
Jane Perlmutter

Patient Centric Trial Design: It's More Than Just the Trial
Joseph Kim

FDA Perspective
Elektra Johanna Papadopoulos

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

As clinical care moves toward increasingly patient-centric models, research must also account for the participant’s perspective in order to maximize clinical trial recruitment, enrollment, adherence, and completion. Quality indicators that capture information about participant preferences and challenges can be used to inform clinical trial feasibility. Leveraging mobile technologies, in particular, can potentially empower a participant population, while emphasizing participant understanding of the commitment involved and, simultaneously, easing burdens on sites and study staff. This session will explore mobile applications, including eConsent, and at-home clinical trials, as potential tools—even providing the capacity to conduct remote trials—to spur participation through increased participant engagement, convenience, and satisfaction.

Learning Objectives

Identify emerging technologies and methods for both achieving efficiencies and optimizing effectiveness in clinical trial design; Evaluate quality metrics related to participant satisfaction and challenges associated with study implementation; Assess technologies and methods for their impact on clinical trial feasibility from a participant-focused perspective; Describe how to create an integrated plan, leveraging available technologies and methods, to improve the success of clinical trials.

Chair

Linda M Coleman, Esq, JD

Speaker

Mobile Clinical Trial Technologies: Use Cases and GCP Compliance Considerations
Philip J. Coran, Esq

Mobile Technology in Research: A Compliance and Ethics Review Perspective
Linda M Coleman, Esq, JD

Mobile Health Applications and eConsent: A Sponsor’s Perspective
Kevin Hudziak, MS