Real-world comparator cohorts (RWCC) are increasingly being used in clinical trials as synthetic controls particularly in rare and complex disease populations and in settings where randomized controlled trials (RCTs) are infeasible or unethical. While RWCCs offer potential benefits such as increased efficiency, reduced costs and improved generalizability, their use also raises methodological challenges.
This webinar will delve into methodological considerations surrounding the use of RWCCs in clinical trials, covering topics such as:
- Role in Clinical Research: Reviewing the importance/applications of RWCCs in clinical research
- Study Design: How to select appropriate RWCCs, considering factors such as data source, inclusion/exclusion criteria and potential biases
- Data Sources: Understanding the strengths and limitations of different real-world data sources, including electronic health records, claims data and patient registries, and explore approaches for pooling data from various sources
- Statistical Analysis: Exploring appropriate statistical methods for analyzing RWCC data, including propensity score matching, regression adjustment and instrumental variable analysis
- Bias and Confounding: Identifying and addressing potential sources of bias and confounding in RWCC studies such as selection bias, measurement error and unmeasured confounding
- Case Example: Examine a real-world example of successful use of RWCCs in clinical trials, highlighting best practices and lessons learned
Register now for this webinar today focusing on the use of real-world comparator cohorts in clinical trials and increase the understanding of their growing role in research.
Speakers
Stephanie Butler, PharmD, Principle Practice Lead, Anlitiks
Stephanie Butler, PharmD, is a seasoned healthcare consultant specializing in data-driven market access solutions. Based in Austin, Texas, Stephanie brings over 20 years of experience in devising strategic solutions that bridge the gap between life-changing therapies and patient access and affordability.
As the Principal Practice Lead at Anlitiks Inc., a consultancy revolutionizing the way real-world data is transformed into actionable insights, Stephanie helps life-science companies address critical challenges in product development and market access through data-driven solutions, such as treatment/competitive landscape assessments, target population optimization, product value propositions and robust reimbursement and pricing strategies.
Kitty Rajagopalan, PhD, President & Chief Scientific Officer, Anlitiks
Krithika “Kitty” Rajagopalan, PhD, MPH, is the President & Chief Scientific Officer of Anlitiks Inc., an emerging, disruptive, tech-services consultancy in HEOR, RWE, and market access. She is a life sciences industry veteran and well-published executive with nearly 30 years’ experience in the field of HEOR, RWE, pricing and market access.
Her multi-therapeutic area experience includes oncology, neurosciences, cardiovascular, immunology, and rare disease therapy areas. Notable experience with first-in-class PRO label claims across multiple therapeutic areas and successful track record of successful HTA assessments (NICE, PBAC, SMC, CDR, and other HTA bodies and US Public/Private payors). She is also the owner of copyrights of PRO instruments and has authored over 125+ manuscripts in peer-reviewed journals and presented over 650+ scientific papers.
She is a Pharmacist by training and has a Masters’ degree with a focus on Pharmaceutical Marketing and Consumer Behavior, a PhD focused on HEOR and a Diploma in Public Health.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Real-world evidence
- Health economics and outcomes research
- Research and development
- Medical affairs
- Data science
- Biostatistics
- Market analytics and forecasting
- Epidemiology and drug safety
- Clinical development
What You Will Learn
Attendees will learn about:
- The methodological considerations involved in using RWCCs in clinical trials
- Strategies for designing and conducting robust RWCC studies that minimize bias and confounding
- How to leverage real-world data to generate high-quality evidence for clinical decision-making
Xtalks Partner
Anlitiks
Anlitiks, a pioneering force at the intersection of technology and science, revolutionizing the way real-world data is transformed into actionable insights. At Anlitiks, our core mission is to empower the life sciences sector by providing swift and efficient analysis of real-world data, turning it into evidence that fosters the development of superior therapeutic solutions and enhances patient health outcomes.
Our unique data-agnostic analytic platform-service model, RapidAnalyzer™, is designed to lead the industry in translating complex data into valuable evidence in real-time. We are committed to improving healthcare outcomes through our expertise in real-world evidence generation, market access, and HEOR-related activities. Our consultative approach and dedication to data-driven decision-making enable us to address critical challenges in product development and payment innovation, impacting healthcare globally.
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