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Trk 11: Quality in CT/GCP [clear filter]
Monday, June 27
 

8:30am

#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
Limited Capacity seats available

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



Chair
avatar for Jonca Bull

Jonca Bull

Assistant Commissioner for Minority Health, Office of the Commissioner, FDA
Dr. Bull worked at the FDA from 1994 to 2006. She served as Director of Clinical Regulatory Policy at Genentech and as Vice President for US Regulatory Policy at Novartis, returning to FDA in 2012 to serve in the Office of the Commissioner as Assistant Commissioner for Minority H... Read More →

Speakers
avatar for Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing... Read More →
EP

Elektra Papadopoulos

Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome... Read More →
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Patient Advocate
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of... Read More →


Monday June 27, 2016 8:30am - 9:45am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Limited Capacity seats available

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



Chair
LC

Linda Coleman

Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory... Read More →

Speakers
avatar for Philip Coran

Philip Coran

Principal, Global Compliance and Strategy, Medidata Solutions
Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA