This package is a replay of 10 on-demand session recordings and presentation slides from the Leadership & Professionalism Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Explore the fundamental considerations for effective clinical trial design.
Member: $99 | Nonmember: $149
Participants can earn up to 11 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 31, 2027.
A Blueprint for Building Actionable Diversity Plans for Clinical Trial Recruitment and Retention
With new regulatory expectations coming to the fore for diversity action plans in Phase III studies, this session will focus on sharing the strategies deployed for actionable plans by on leading company. Speakers: A. Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, Merck; Yael Symes, PhD, Senior Medical Writer, Merck
Although the U.S. Food and Drug Administration has taken an active role in extending guidance on the conduct of decentralized clinical trials (DCTs), the industry hasn’t seen yet the scale of their adoption hoped for by many because of lack of trust in sites’ abilities to handle such trials on the part of sponsors. This session explores two different site networks and at a high level, with an emphasis on how they and their sponsors worked to comply with regulatory guidance in two different DCT study designs. Speaker: Noelle Gaskill, Head of Clinical Research Collaborations, Mirati Therapeutics
The current regulatory framework for clinical trials was designed for a different era, when the technology of the time mandated centralization of activities that gravitated toward major research institutions, and less emphasis was placed on access to patients who were representative of the population with the diseases being studied. Diversity in research is a high priority, and modernization of clinical trials is key to improving enrollment of participants from underrepresented racial and ethnic populations and increasing access to care. Innovations in technology and trial design have the potential to unlock a new era of clinical research that is more convenient for patients, more reflective of real-world treatment conditions, and more likely to enable participation of a diverse set of individuals. This session will examine how modernized approaches to key regulatory and legislative policies could accelerate the availability of new and breakthrough therapies to patients in need. Speakers: Sara Edwards, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly and Company; Stacy Holdsworth, PharmD, Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company
Creation of an informed consent form can be a time-consuming process, laden with unexpected delays and protracted negotiations between sponsors, institutional review boards (IRBs), and other stakeholders in clinical research. This session will help attendees to better understand the life cycle of an informed consent form as it moves from a global study template to a site-specific document that is used to share critical information with study participants, and to learn strategies for positioning sites with strong rationale for making critical revisions. Speaker: Dawn Pedinelli, Senior Manager, Astellas Pharma
This presentation will provide an overview of how adaptive design trials are often considered more complex than traditional trials, the different types of adaptive trials that are usually accepted by regulators, typical logistical/operational challenges encountered during their implementation, and solutions to overcome such challenges. Speaker: Vatche Bartekian, President, Vantage BioTrials
Even more important than the development of a clinical trial Diversity Plan is the ability to move from intentions to actions in support of diversity, equity, and inclusion in clinical research. This panel discussion will share one company’s approach to developing Diversity Plans, including actionable strategies that are being employed in a cross-functional and collaborative manner. Speakers: A. Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead, Merck; Michelle Chawla, Diversity Program Lead, Merck; Cameron Davis, Associate Director, Clinical Trial Diversity, Merck; LaShanda Gordon, Associate Director, Diversity Program Lead, Merck
With new regulatory guidance, research staff are now asked to stretch beyond their traditional channels to enroll a diverse and inclusive study population. This session will focus on outlining a map, mobilize, and measure strategy to define diversity beyond race and ethnicity and to identify and measure effective channels and strategies to support diversity enrollment goals. Speakers: Linda Davison-Ray, MA, Director, Equity, Diversity, and Inclusion, Duke Clinical Research Institute; M. Patricia McAdams, MS, CCRA, Associate Director, Research Communications and Engagement, Duke Clinical Research Institute
Please join David Burrow from the FDA’s Center for Drug Evaluation and Research (CDER) as he discusses the transformation of clinical research and the advancement of drug development and clinical trial design. David will share perspectives on various clinical trial innovation activities including evolving study designs (e.g., master protocols), operational approaches (e.g., decentralized clinical trials (DCT)), and data sources (e.g., real-world data (RWD)). Hear directly from CDER’s Office of Compliance on balancing the critical interests involved in supporting innovation in clinical research along with the FDA’s role as a global regulatory and enforcement agency focused on protecting public health. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Since the passage of the Orphan Drug Act in 1983, the rare disease patient community has been an active force in the advancement of research and innovation in clinical trials. This session explores the history of clinical research targeting rare diseases, the role rare disease patient advocates have played in advancing innovative clinical research methodologies (including decentralized clinical trials), and what the broader clinical research community can learn from the rare disease community about recruitment and diversity in clinical trials. Speaker: Stephanie Christopher, MA, CCRC, FACRP, Director, Patient Advocacy, Pfizer
As regulatory expectations concerning greater diversity in clinical trials ramp up, a key change in focus for the clinical research enterprise becomes understanding the importance toward the patient experience of incorporating community outreach and engagement into site and sponsor operations. This session offers practical examples of tactics tied to diversity plans, community-based patient engagement, and clinical study recruitment efforts. Speaker: Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager, SiteBridge Research Inc