Tuesday, March 29, 2022 at 1 pm EST, 12 pm CST, 10 am PST The popularity of decentralized clinical trials (DCTs) is making oversight of investigators more critical. As trial operations spread and become more remote, the role of the investigator as a center of gravity becomes increasingly vital. Approaching regulatory agencies to understand if there are regulatory issues with a proposed DCT solution will likely lead to more non-standardized regulations, which in turn creates additional regulatory uncertainty. What can be done?
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Decentralized clinical trials (DCTs) offer a new approach to running studies with the promise of increased study access and retention, especially acute for individuals with a rare disease—but the trial functions are not new. They are in most cases a decentralization of the investigator’s role in a clinical trial, and this role is clearly defined in the international good clinical practice ICH E6 (R2) guidelines and implemented regulations or directives.
The popularity of DCTs is making oversight of investigators more critical. As trial operations spread and become more remote, the role of the investigator as a center of gravity becomes increasingly vital.
Regulatory agencies have a variety of approaches to DCTs, but currently, there is no international standard. This is a major problem since most trials are intended to produce globally reflective results. Approaching these agencies to understand if there are regulatory issues with a proposed DCT solution will likely lead to more non-standardized regulations, which in turn creates additional regulatory uncertainty. What can be done?
Key Learning Objectives:
Who Should Attend:
ISAAC R. RODRIGUEZ-CHAVEZ
Senior Vice President, Scientific & Clinical Affairs
Dr. Isaac Rodriguez-Chavez is a biomedical leader with expertise in infectious diseases (viral immunology, viral oncology, microbiology), immunology, and vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phases I–IV), non-interventional clinical research, and post-marketing studies. He also has expertise in digital health technologies, modern clinical research development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance.
Dr. Rodriguez-Chavez joined ICON plc as a senior vice president for scientific and clinical affairs, leading the strategy of ICON’s decentralized clinical trials (DCTs) and digital medicine, including digital health technologies (DHTs)/digital wearable devices, digital endpoints, digital therapeutics, software as a medical device, and electronic clinical outcome assessments.
He has a BS in biology (Venezuela), MS in microbiology (Venezuela), MHS in clinical research (Duke School of Medicine), and a PhD in virology and immunology (University of Delaware). He did two post-doctoral specialty trainings in viral immunology and viral oncology linked to clinical research at the National Institute on Aging (NIA) and the National Cancer Institute (NCI) at NIH.
Dr. Rodriguez-Chavez is interested in driving clinical research modernization and in implementing advances in digital medicine for the industry.
Recherche Transformation Rapide
Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advises cancer centers, life sciences, AMCs, hospitals, and health systems process improvement initiatives for productivity, quality, and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP, and GCP.
Stevens has over 20 years of research/R&D experience, including over 12 years in research management serving in roles such as vice president research, senior managing director, director clinical trials office, director of clinical research, interim executive director, clinical trials office, and director of research operations. She is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer-reviewed journal publication for ACRP, and is the chair of the associate board of trustees. She is a director for Brightpoint Care and served on the MAGI advisory board. She is also a frequent speaker on research operations and compliance practices at international conferences.
Additionally, she is a published author whose work appears in a variety of peer journals including the “American Journal of Obstetrics & Gynecology,” “The Monitor,” “Clinical Researcher,” “Regulatory Focus,” “Applied Clinical Trials,” “Clinical and Translation Science,” and the “Journal of Mental Health and Aging.”
Stevens holds her BA from the University of Vermont, her MA from Case Western Reserve University, and her MA from Temple University. She also holds a graduate certificate in gerontology from Case Western University.
Risk Based Approach Ltd
Andy Lawton is one of the world’s leading experts on the implementation of risk management and quality by design in clinical development. He has provided ICH E6 R2 and ICH E8 consulting to over 40 companies/groups across five continents. He has extensive experience in computing, statistics, data management, RDE/RDC, system design, and risk-based approach in both CSV and clinical trials.
Lawton has 46 years of experience in the pharmaceutical industry and the UK’s NHS, and was a founding committee member of ACDM, a member of TransCelerate RBM work stream, and a member of EFPIA WG on Data Transparency.His most notable publications, include a paper with Dr. Alistair Ross on GP audit. Throughout the 1980s and 1990s, this was the most quoted paper in “The BMJ,” and he won “best author of the year 2015 and 2016” from the DIA, for his TransCelerate papers on SDV and central monitoring in the “TIRS Journal.”
Director, Industry Strategy
Oracle Health Sciences
Elvin Thalund is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including Hoffmann-La Roche and Johnson & Johnson. Thalund works as a product strategist and system architect in Oracle Health Sciences’ effort to optimize study startup. He is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.
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