The concept of Real-Time Clinical Trials (RTCT) has recently gained significant attention following the FDA’s introduction of the RTCT initiative and the launch of pilot programs to explore its feasibility. Traditionally, clinical trials have relied on periodic data collection, cleaning, analysis and reporting, resulting in potential delays between data generation and clinical decision-making. This webinar explores how RTCT could address these delays through a more continuous and connected approach to study oversight.
RTCT envisions an environment in which safety, operational performance and the benefit-risk profile can be monitored, evaluated and acted upon as data are generated throughout a study. The initiative addresses several longstanding challenges in clinical research, including operational inefficiencies, delays in data availability and limited real-time visibility into study conduct, patient safety and treatment effectiveness.
This webinar will discuss the regulatory vision driving its development and its potential impact on sponsors, CROs, investigators, data monitoring committees (DMCs), newly required independent safety assessment entities (ISAEs) and regulatory agencies. Participants will gain insights into how advances in digital technologies, artificial intelligence (AI), electronic health records (EHRs) and real-time analytics, guided by aggregate safety and benefit-risk assessment planning, may result in a new generation of continuous clinical trial oversight and decision-making.
Attendees will also learn about current challenges involving source-to-EDC data flow, interoperability, data quality, privacy protection, governance and regulatory compliance. The webinar will examine opportunities to improve patient safety, trial quality, operational efficiency and development timelines, as well as practical considerations involving technological readiness, organizational transformation, assessment planning and regulatory expectations.
Register for this webinar to learn how Real-Time Clinical Trials may improve patient safety, trial oversight and clinical decision-making.
Speakers
(Moderator) Tai Xie, PhD, CEO, CIMS Global
Tai Xie obtained his PhD in Statistics from the University of Arizona. He is the Founder and CEO of CIMS Global and previously founded Brightech, which was acquired in 2022. Prior to that, he spent 10 years at pharmaceutical companies, including Pfizer, Johnson & Johnson and Eli Lilly, where he gained expertise in clinical trials, statistical analysis, reporting and regulatory submissions.
Tai advocates using open-source tools (R and Python) and AI in clinical trials. He leads a team of over 40 developers to build innovative platforms, such as Compliant R Environment (CRE), DMC-HUB and AI governance solutions.
Tai is a thought leader who shares insights on clinical data analytics and AI adoption on LinkedIn and other professional platforms. He specializes in adaptive trial design and co-invented Dynamic Data Monitoring (DDM), which has been used successfully in multiple clinical trials.
Message Presenter
(Panelist) Randall Hein, Founder & Managing Partner, Heinsight
Randall Hein is a Life Sciences Executive with more than 28 years of operational leadership experience in the clinical research industry, spanning clinical site operations, data and scientific services, regulatory affairs and consulting. His previous leadership roles include Chief Development Officer and President, Consulting Services at Advarra, Senior Vice President of Clinical Research Services at PRA Health Sciences, General Manager at DaVita Clinical Research and Director of Data Services at MDS Pharma Services.
Today, Randall serves as an Advisor and Board member of emerging life sciences companies, supporting strategy, operational excellence and the adoption of technologies that improve the efficiency, quality and execution of clinical research.
Message Presenter
(Panelist) Jay Herson, PhD, Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health
Jay Herson received his PhD in Biostatistics from Johns Hopkins in 1971. He worked briefly in Health Surveys and Epidemiology before joining the faculty of M.D. Anderson Cancer Center, Houston, in 1976. There, he worked on both intramural clinical trials and those of the Southwest Oncology Group. He developed an interest in survival analysis, interim analysis and safety analysis. In 1983, he formed Applied Logic Associates in Houston, a company that grew into a CRO and worked on industry trials. It was here, in 1988, that he served as a member of the first data monitoring committee for an industry-sponsored trial. ALA went on to support many DMCs, and also served as a Statistical Member of many DMCs where ALA was not involved. He sold ALA to Westat in 2001 and then joined the Faculty of Biostatistics at Johns Hopkins, where he taught graduate courses and mentored faculty and students. In addition to numerous publications, he wrote the book Data and Safety Monitoring Committees in Clinical Trials. The second edition was published by CRC/Chapman and Hall in 2017. He continues to serve on data monitoring committees and consult with startup firms on both statistical design/analysis and regulatory affairs.
Message Presenter
(Panelist) Scott Proestel, MD, Principal, Bethesda Pharmaceutical Consulting, LLC
Scott Proestel is a board-certified Physician (Internal Medicine and Clinical Informatics) and former FDA Division Director with over two decades of experience in clinical research, including 19 years at the FDA conducting pre-market drug and biologic assessments and post-market safety surveillance. He has also overseen six global clinical trial networks at NIH and served as an Assistant Professor of Medicine at Georgetown University. He completed his internal medicine training at Johns Hopkins Hospital and earned his Medical Degree from Columbia University.
Scott currently provides consultations to pharmaceutical and biotech companies regarding Clinical Product Development, FDA Regulatory Strategy and Safety Analytics, and serves as Co-Chair of the PHUSE Safety Analytics Working Group.
Message Presenter
(Panelist) Greg Ball, PhD, Safety Data Scientist, ASAPprocess Consulting
Greg served in the Navy and taught high-school math and physics before earning his MS in Statistics from Purdue and his PhD in Biostatistics from the University of Texas. He was the main driver at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His seminal research on blinded safety monitoring procedures is being developed by Clinical and Statistical Scientists at numerous pharmaceutical companies. Greg co-established the ASA Biopharm Safety working group and currently co-leads the PHUSE Safety Analytics working group
Message PresenterWho Should Attend?
This webinar will be relevant to professionals across pharmaceutical companies, biotech organizations, CROs and clinical research teams involved in clinical trial strategy, operations, data oversight and regulatory decision-making, including:
- Clinical Trial leaders and Clinical Operations professionals
- Sponsors, CROs, Investigators and Study Team decision-makers
- Data Monitoring Committee members and professionals involved in Safety or Efficacy Review
- Clinical Data Management, Biostatistics, Statistical Programming and Analytics teams
- Regulatory Affairs, Quality, Compliance and Governance professionals
- Digital Transformation, AI, Automation and Clinical Technology leaders supporting modern trial infrastructure
What You Will Learn
Attendees will gain insight into:
- What Real-Time Clinical Trials are and why they are gaining attention across clinical research
- How real-time data access, monitoring and analytics may improve patient safety, trial efficiency and decision-making
- The opportunities created by AI, automation, cloud computing and advanced analytics in modern trial oversight
- Key challenges around data quality, source data integration, governance, privacy and regulatory compliance
- Practical considerations for sponsors, CROs, DMCs and regulators as clinical trials become more data-driven and continuously monitored
Xtalks Partner
CIMS Global
With over 16 years of industry experience, CIMS has pioneered the reshaping of clinical trials with novel technologies and services that streamline and fast-tracks clinical trials creating pathways for life-saving therapies. We bridge the gap between visionary researchers and effective treatments with speed and reliable data with a powerful toolkit.
CIMS Global specializes in delivering innovative data science services and solutions for clinical trials. By leveraging proprietary and advanced technologies, including Artificial Intelligence (AI), Large Language Models (LLM), Natural Language Processing (NLP), and Machine Learning (ML) coupled with advanced statistical methodologies, CIMS Global accelerates and enhances the quality and efficiency of clinical trial data acquisition, processing, analysis, and regulatory submissions.
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