Clinical studies are notorious for delivering late. Most delays are at the point of contact with the patient. Yet, during the COVID pandemic, clinical trials were delivered at unprecedented speed. Each COVID vaccine called for studies with upwards of 30,000 subjects and were delivered in weeks, not months. Evidently, the problem of scaling clinical trials can be overcome. Given the difficulty of patient accumulation we normally see, how did that happen and is it repeatable?
Patient recruitment has traditionally relied on brick and mortar research sites, which run very few studies and have limited opportunity to achieve a high level of competence. The CROs of the 20th century held the promise of establishing better site relationships and supporting a more organized infrastructure. Multi-site organizations, focused purely on research, have evolved but have not scaled to meet voracious global industry demand. Decentralized methodologies have attempted to re-engineer patient interaction so fewer sites are needed.
Did COVID-19 studies signal a turning point for patient accumulation to truly scale future research, or were they the exception that proves the rule and we will never effectively scale clinical trials?
Questions to be covered during the webinar include:
• How can we deliver clinical research at scale?
• What is the role of technology in increasing clinical trials efficiency?
• Is the site landscape in need of a radical rethink or a make-over?
• How do we achieve the same patient engagement levels seen during the coronavirus pandemic?
Speakers:
As a former Executive Director of the ACRP, Kremidas brought more than 30 years of experience in the health care industry, including positions in the lab, sales, marketing, strategic sourcing, and clinical operations at Eli Lilly and Company, Quintiles, in Ventiv Health, and CenterWatch. While at Lilly, he led the development of the first functional area to focus on global enrollment optimization.
Kremidas is a founding advisory board member at the Center for Information & Study on Clinical Research Participation and a volunteer for the Clinical Trials Transformation Initiative. The Association of Clinical Research Professionals is key to the progress of the clinical research enterprise. He was honored to have the opportunity to lead this organization into the future and to support our 13,000 members around the world in their pursuit of excellence in clinical research.
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Paul joined Velocity Clinical Research as President and CEO in 2018 after 26 years of “perfect symmetry” in the site business: 13 years running sites and 13 years managing them on the sponsor / CRO side. He has held positions at PAREXEL and IQVIA in site solution roles, and was a founder and managing director of Synexus.
He holds a PhD in Biomedical Engineering from the University of London. Paul joined Velocity Clinical Research to take on what he sees as one of the fundamental industry challenges: “Patient recruitment is still the biggest problem in clinical trials. I want Velocity to set a new industry standard for delivering high-quality study data as quickly and efficiently as possible.” He has served on the Board of Trustees for the Association of Clinical Research Professionals (ACRP) since 2017 and was Chairman in 2020.
Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University.
Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.
Adam has over 25 years of clinical research experience, with the last 8 at Merck. He has been a key leader within GCTO, most recently serving as Executive Director, GCTO Clinical Sciences & Study Management (CSSM) and Therapeutic Area Section (TAS) Head: Melanoma, Hepatobiliary Cancers, and Innovative Strategies. Previously, Adam was Clinical Research Director (CRD) Oncology where he served as Director of country clinical operations activities in the United States for Merck’s oncology pipeline.
Adam started his career as a CRA and has traversed through various roles in clinical operations of increasing responsibility and scope. He also has experience across a wide array of therapeutic areas and with companies of different sizes and operating models.
Adam has a bachelor’s degree in biology from Rice University in Houston. He completed post-baccalaureate course work at Houston Baptist University and coursework toward a Master of Public Health (MPH) degree at the University of Texas School of Public Health in Houston.
With more than three decades at IQVIA, Mark Brown, vice president, Global Patient and Site Solutions, has touched on several areas of expertise in clinical research. From his initial role providing user support and training through the Information Technology group in 1990, Mark transitioned to the Clinical Data Management group, where his initial responsibilities included clinical documentation and NDA preparation. Those responsibilities expanded until he served as Head of Data Management for the Research Triangle Park office.
Soon after, Mark served as Product Director for a new automated data capture software system. He built on that experience to serve as head of System Compliance and Validation for Scientific Operations. Moving into the site management group, he initially focused on enhancing site identification and soon developed the investigator performance warehouse used initially to prioritize site selection for clinical trials and ultimately for the business analytics source data. Growing responsibilities to include protocol & patient feasibility, Mark helped oversee the team responsible for prioritizing both countries and investigators and building patient recruitment scenarios to execute clinical protocols through phase II through IV protocols. Most recently, Mark’s remit expanded to the recently formed Global Patient and Site Solutions, which includes the Patient Recruitment Operations team and the Avacare site management organization.
In 2020, Mark led the creation and launch of IQVIA’s site enablement service to support research sites by addressing flexible staffing needs due to dynamic workloads due to large COVID-19 vaccine research trials and related staffing shortages. This led to placement of more than 900 research staff in less than six months.
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