The new draft US Food and Drug Administration (FDA) guidance on the use of data monitoring committees (DMCs) in clinical trials marks the first update in nearly 20 years. This revision introduces several significant changes to the management and operation of DMCs in clinical trials.
In this webinar, the expert speakers will explore these important updates and their implications for DMCs. Attendees will learn how the potential changes in the guidance will affect the operational aspects of DMCs, including management, statistical analysis and delivery.
This webinar will also provide a comprehensive overview of recent updates and changes in the context of safety data review and management. The discussion will focus on the various committees involved, including those responsible for adaption, safety assessment and a specific mention of non-independent safety committees.
The expert speakers will cover essential topics such as committee membership, conflict of interest (COI) and confidentiality policies. The session will also delve into the standards and protocols for COI, the methodologies used in statistical analysis and the requirements for accurate and timely reporting. Moreover, they will identify the entities responsible for reviewing safety data, ensuring all participants understand their roles and responsibilities in maintaining data integrity and compliance.
Register for this webinar today to stay informed about the new draft FDA guidance on the use of data monitoring committees in clinical trials.
Speakers
Patricia Braschayko, Senior Manager, Biostatistics, ICON
Patricia Braschayko has 18 years of biostatistics and programming health research experience spanning pre-clinical to Phase III clinical trials, including 7 years in management roles. She has led studies for federal, large pharma and small biotech clients across a wide variety of indications. She is dedicated to protecting patient safety by ensuring data review committees are provided with accurate, complete and timely data to support trial oversight.
Message Presenter
Karen Shaffer, Director, Biometrics (DMC Unit), ICON
Karen Shaffer is a registered nurse with over 25 years of clinical research experience spanning small biotech and large pharmaceutical companies. Her diverse roles have included positions in clinical sites, medical information, drug safety and over 15 years specialising in data monitoring committees (DMCs). Karen has managed over 100 DMCs for government-led studies, major pharmaceutical firms and small biotech clients. She currently oversees a team of 18 project managers, statisticians and programmers across multiple therapeutic areas.
Message Presenter
Birgit Geiger, Manager, IDEA (DMC Unit), ICON
Birgit Geiger is a registered nurse and a seasoned manager with 19 years of clinical research experience, including 16 years in data monitoring committee (DMC) management and 8 years in pharmacovigilance and regulatory affairs.
Since 2015, she has led the ICON DMC team across Europe, India and Japan, providing portfolio oversight for major pharmaceutical companies and small biotech firms. Birgit excels in organisational skills, effective risk management and process improvement, consistently delivering high-quality results in fast-paced environments.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals from pharma and biotech companies or those with the following job titles:
- Biostatisticians
- Data monitoring committee members
- Regulatory affairs
- Ethics committee members
- Clinical operations
- Clinical Project Managers
- Safety Committee Consultants
What You Will Learn
Attendees will:
- Understand the history and evolution of DMC guidance and get a comprehensive look at the major revisions and their rationale
- Learn about new requirements for committee formation and function and discover best practices for adapting to the new guidance
- Learn about updated guidelines on committee membership, managing conflicts of interest, and ensuring confidentiality
- Get insights on how the new guidance affects statistical analysis and data interpretation and get up to speed on the latest reporting requirements for DMCs
Xtalks Partner
ICON
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.
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