Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices

Some or all aspects of a decentralized clinical trial are conducted in locations that are not centralized at a specific research site, which can raise unique regulatory considerations. Equip your future digital/decentralized trial IRB and ethics submissions for success with a toolkit from MRCT and Medable that will be shared during this upcoming webinar.

Register Free: https://www.appliedclinicaltrialsonline.com/act/best-practices

Event overview
The MRCT Center and Medable created a task-force of diverse stakeholders with a core objective: tackling the nuanced ethical queries and regulatory discussions that arise with Decentralized Clinical Trials (DCTs).

DCTs are studies executed either in whole or in part remotely, through telemedicine, mobile technologies, local sites, and mobile healthcare providers. This may greatly increase the efficiency and/or reach of a trial, but there are specific differences to consider between DCTs & traditional trials...

Medable & MRCT’s joint undertaking will be discussed in this comprehensive webinar, In the words of Dr. Barbara Bierer from MRCT Center, "The ultimate intention of this initiative is not just to provide a useful framework, but to truly equip IRBs, ethics committees, and sponsors with the essential organizational tools and guidelines that enable proportionate ethical review of DCTs."

These tools & guidelines are grouped into 3 domains: People, Remote Data Collection, and Data Oversight, with 12 total components that feed into a particular domain.
Join this webinar where 4 industry spanning experts will cover how to equip your future digital/decentralized trial IRB & ethics submissions for success!

Key Learning Objectives

• Dr. Bierer and Dr. Tenaerts will share best practice guidance encapsulated across all 12 distinctive components - including eConsent, recruitment & remote visits.
• Jeff Nichols will highlight aspects of privacy and security unique to DCTs.
• Carl Franzetti will detail issues related to devices (phones and tablets) utilized in DCTs

Who Should Attend

• Clinical Operations/Development, TA Leads, R&D, Study Management, Project management, Regulatory leads, Compliance leads, Privacy leads, Chief Medical Officers, Chief Scientific Officers, Medical Affairs, Procurement, Clinical IT, Data management/processing/analysis, and HEOR
• Large Pharma and Mid-Market Biotech & CROs

Speakers:

Pamela Tenaerts
Chief Scientific Officer
Medable, Inc.

Pamela Tenaerts is Chief Scientific Officer at Medable, Inc. Dr. Tenaerts leads efforts at Medable to drive responsible advancement of decentralized research methodologies with evidence-based metrics and best practices. Dr. Tenaerts joins Medable from Duke University, where she led the Clinical Trials Transformation Initiative’s (Public Private Partnership co-founded by Duke University and the Food and Drug Administration) efforts to develop and drive adoption of practices that increase the quality and efficiency of clinical trials. She is a member of the Drug Forum at the National Academies of Science and a Board Member of the MedStar Research Institute and is a Dime Founding Members Council member.

Tenaerts is one of the leading advocates for innovation in clinical trials, with an emphasis on patient engagement, responsible evidence generation and clinical trial methodology improvements. With more than 30 years’ experience in the conduct of clinical trials across a number of stakeholders, she practiced medicine in both the emergency department and as a family practitioner in the private practice setting for several years before embarking on a career in research. She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida.

Barbara E. Bierer, MD
Professor of Medicine
Harvard Medical School

Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to improve standards for the planning and conduct of international clinical trials to harmonize policies for and approaches to clinical trial regulation. In 2017, the MRCT Center launched the non-profit organization, Vivli (www.vivli.org), a global clinical research data sharing platform. In addition, she is the Director of the Regulatory Foundations, Ethics, and the Law program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable the clinical trial enterprise from study planning through recruitment to data acquisition and dissemination. She is the Director and PI of SMART IRB (www.SMARTIRB.org), a national effort to align single site IRB review of multi-site trials. She serves as Faculty in the Center for Bioethics, Harvard Medical School, and as Affiliate Faculty in the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research at the Brigham and Women’s Hospital (BWH). During her tenure, Dr. Bierer founded and served as Executive Sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare. She has authored approximately 300 publications.

In addition to her academic responsibilities, Dr. Bierer served or serves as Chair of the Secretary’s Advisory Committee for Human Research Protections, Department of Health and Human Services (2008-2012); as a member of the National Academies of Sciences Committee on Science, Technology and the Law (2007-2016), and NASEM Forum on Drug Discovery, Development, and Translation (2023-); on the Executive Committee, Clinical Trials Transformation Initiative (2023-); on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R) (2011-2020), Management Sciences for Health (MSH) (2013-2022), Vivli (2017-), North Star Review Board (2020-), and Generation Patient (2023-). She chairs the Board of Trustees of the Edward P. Evans Foundation, a foundation supporting biomedical research, and is on the board of directors of Clinithink, a company that transforms unstructured clinical text into computable data for clinical trials and population health management.

Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.

Jeff Nicol, CIPP/G, CIPP/US, CIPP/E, CIPM, CIPT, FIP
VP, Global Privacy
Medable, Inc

Jeff Nicol is VP, Global Privacy at Medable, Inc. Jeff entered the privacy space back in 1999 as Intel’s first dedicated privacy resource. He built the global privacy team at Intel, with initial focus on customer and worker data privacy, along with early forays into product privacy engineering and ‘privacy-by-design’. He moved on from Intel to start Privacy Ready LLC, a boutique consulting practice doing foundational privacy operations work for the likes of TRUSTe and Cisco Systems. Privacy Ready had many repeat customer engagements, earning Mr. Nicol accolades from ComputerWorld as one of the ‘Top 25’ Privacy Experts. Prior to joining Medable in fall 2020, Jeff lived in Germany where he was a privacy expert for Huawei’s Consumer Business Group.

Jeff received a B.S. in International Business from California State University, holds multiple IAPP privacy certifications, and has been awarded the IAPP’s Fellow of Information Privacy designation.

Carl Franzetti
Technology Operations
Medable, Inc

Carl is the VP of Technology Operations at Medable. In this role, he oversees the training, onboarding and support of all users of Medable’s platform to include site users, participants and study builders. He also oversees the procurement, programming and global distribution of all study related electronic equipment (handheld devices and connected sensors / wearables).

Prior to joining Medable, Carl’s experience includes executing complex operations around the world as part of the United States Marine Corps and United States Cyber Command, obtaining the rank of Major before moving on to the private sector. Since his time in the United States government, Carl has worked in a series of startups in the clinical and technology space, executing global eCOA and overseeing global manufacturing and distribution of handheld electronics at other organizations before ultimately coming to work at Medable.

Carl has earned an MBA from the University of Maryland, a B.A. from Montclair State University and his Project Management Professional certification from the Project Management Institute amongst other certifications.

Register Free: https://www.appliedclinicaltrialsonline.com/act/best-practices