CONFERENCE PRESENTATION · SCDM 2021 Global Conference
In Conduct of Decentralized Trials - Patient "IS" the Source
- Session Type: Oral Presentation
- Session Level: Intermediate
Overview
In today’s new environment, the Patient has become the central focus and challenge for clinical trials. Dramatic progress mushroomed after COVID and regulatory direction encouraged Sponsors in their approach to decentralized clinical trials (DCT). The goal of this panel is to discuss the new patient centric model for clinical trials, challenges found in globalization of clinical trials, successful strategies for including wearables, RWE/RWD, ePRO/eCOA, eSource, and analytics that disrupt the traditional model for clinical trial partnering and patient participation. Included in this presentation will be a case study using electronic medical records (EMR) and a deeper dive into medical claims data used in decentralized clinical trials.
What You'll Learn
- When the Patient is the Source in DCT, what are best practices for data management when moving to a hybrid or virtual setting?
- What are the globalization challenges impacting the implementation of DCT?
- What are best practices for Sponsors and CROs when it comes to leveraging Electronic Health Records and Medical Claims Data?
- In a case study, what are the lessons learned from challenges, limitations and lessons learned from employing EHR in a DCT?
Meet the Presenters
Sina Adibi
CEO
Adaptive Clinical Systems
Sina Adibi has over 25 years of experience in life sciences informatics. He is the founder of Adaptive-Clinical Systems, makers of the Adaptive eClinical Bus; A Simple, Validated, and Cost-Effective Solution for Clinical Data Integration. As Chief Technology Officer (CTO) at Parexel, Inc., he was responsible for design and development of eClinical technologies, such as IRT, EDC, CTMS, and medical imaging. As CTO at Thomson-Reuters Scientific & Healthcare, he had responsibility for scientific, technical, medical information management systems, data capture and content enhancement systems.
Adaptive Clinical Systems
Leah Mulfinger
Sr. Lead Data Manager
ICON
Leah is a Lead Data Manager at ICON, plc with 10 years of Clinical Data Management experience. In the last 2 years, Leah has lead Data Management activities on 2 fully decentralized clinical trials (DCT). Leah has gained extensive experience working with real world data, including medical claims data and EMR/EHR-EDC Integrated data.
ICON
Brian Smith
VP of Data Management
Science 37
Brian Smith has over 20 years of experience in the Clinical Trials space. He has been working at Science 37 since April 2021 and is the Vice President of their Data Management organization, leading the design and delivery of their direct data capture platform.
Science 37
Brian’s past roles include Vice President of Data Management at ERT and Vice President of Operations at iCardiac Technologies. His experience in clinical trials includes Central Laboratory, ECG Core Lab, Respiratory Core lab and eCOA capabilities across operations, project management and data management in multiple organizations.
Scott Bull
Clinical Scientist
Janssen R&D
Scott Bull is a Clinical Project Scientist at Janssen R&D with over 20 years of clinical research experience. He has led multiple late-stage clinical development programs and has participated in the preparation and submission of New Drug Applications. His R&D experience includes pragmatic/virtual trial design by leveraging Electronic Heath Record (EHR) data. Most recently Scott has led a workstream to harmonize and collect EHR data from sites participating in a phase 3 clinical study. The EHR data will be used to support trial monitoring and will be compared to data collected through the traditional eCRF/EDC process to assess quality and completeness.
Janssen R&D
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
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