AF and VTE: Global Considerations in the Evolving Space of Real-World Data

Setting the Stage of Real-World Data vs RCT

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Announcer:
Welcome to CME on ReachMD. This episode is part of our MinuteCE curriculum. Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements as well as the learning objectives.

Dr. Lopes:
Hello, this is CME on ReachMD, and I'm Dr. Renato Lopes. And I'll be discussing with you today about real-world evidence setting the stage and pointing out the main differences between real-world evidence and randomized clinical trials.

So it's important to realize that when we talk about data, there is actually a data universe where there are different types of studies and different study designs that can answer different types of questions. So in one hand, we have what we call the, really, non-real-world data, which has basically been coming from the traditional randomized clinical trials. Then, on the other side of the spectrum, we have what we call the real-world data, where basically the data is being collected for non-research purpose, but then we decided to do research with that data. So by nature, this type of data is always observational, whereas randomized trials are prospective and we always have an assignable intervention.

So with that in mind, you can always characterize or classify the type of study to closer to randomize trials or to be a randomized trial or closer to a real-world data type of study. In other words, how can we define real data? It’s really routinely collected data relating to patient health status and/or healthcare delivery. And every time we're going to be analyzing that data to potentially define benefits and/or risks of any medical product, that's what we call real-world evidence.

So, again, we can appreciate in this slide that we have different types of studies that are designed and well positioned to answer specific types of questions. It’s not about being right or wrong or being the best type of study; it’s about what is the question? So depending on my research question, I'm going to have better designs and different types of studies to answer that in a more appropriate way.

So in a nutshell, randomized trials, they are prospective, they have, obviously, randomization, which is the magic to make the 2 groups or the 3 groups, or how many groups we have in that study, balanced in terms of baseline characteristics. And because of that, we can assess causality in between the treatment and the effect. On the other hand, for real-world observational studies, they are observational in nature, they are non-randomized, and that's why we can’t always talk about associations between treatment and an effect. It’s very difficult to talk about causality when we don't have randomization.

So in summary, randomized clinical trials are still the gold standard for assessing treatment effects if we didn’t know if a drug or a device is better than another one. However, real-world evidence really complement the information that we have from the randomized trials. And remember, there is no perfect study. The important thing is to really define what is the recent question? And then understand what might be the best design to answer that question. There are strengths and limitations of real-world studies, and one needs to be fully aware of them before interpreting the results so we don’t run the risk of overstating results that the study might not allow us to do so.

Then, in the new era of clinical research, of being more pragmatic, the real-world evidence is becoming more and more important to really overcome the complexity around randomized clinical trials. It might really help in the evidence generation and regulatory process, together, in innovative designs such as, for example, the registry-based randomized trials where we can combine real-world type of data together with a randomization and maybe have a very innovative study design to answer clinical questions.

Thank you very much for listening.

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Overview
The effective management of atrial fibrillation (AF) remains a high priority for many clinicians worldwide because a significant number of people globally who are living with AF are at risk of developing venous thromboembolism (VTE). This makes our understanding and implementation of new findings and clinical trial outcomes that much more important as we develop effective, personalized treatment plans for our patients. Tune in to our micro learning course to make sure you’re up to date and providing the care your patients deserve.
Disclosure of Relevant Financial Relationships
In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Chair:
Renato D. Lopes, MD, MHS, PhD
Professor of Medicine, Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute
Durham, NC
Dr. Lopes has reported the following relevant financial relationships or relationships with ineligible companies of any amount during the past 24 months:
Consulting Fees: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Novo Nordisk, Pfizer
Contracted Research: Amgen, Bristol-Myers Squibb, Glaxo Smith Kline, Medtronic, Pfizer, Sanofi
Faculty:
Valeria Caso, MD, PhD
Stroke Unit
Santa Maria della Misericordia Hospital
Perugia, Italy
Dr. Caso has reported the following relevant financial relationships or relationships with ineligible companies of any amount during the past 24 months:
Consulting Fees: Bayer, BMS, Daiichi Sankyo, Ever Pharma, Pfizer
Alexander T. Cohen, MD, MBBS
Consultant Vascular Physician
Guy’s and St Thomas' NHS Foundation Trust
King's College London
London, UK
Dr. Cohen has reported the following relevant financial relationships or relationships with ineligible companies of any amount during the past 24 months:
Consulting Fees: AstraZeneca, Bayer, BMS, Pfizer
Contracted Research: AstraZeneca, Medtronics
Reviewers/Content Planners/Authors:
- Cindy Davidson has no relevant relationships to disclose.
- Anita Galdieri, PharmD, has no relevant relationships to disclose.
- Brian P. McDonough, MD, FAAFP, has no relevant relationships to disclose.
- Katie Sheridan, PhD, has no relevant relationships to disclose.
Learning Objectives
After participating in this educational activity, participants should be better able to:
- Identify the challenges in using real-world evidence when making clinical decisions in everyday practice for the management of atrial fibrillation (AF) or venous thromboembolism (VTE)
- Optimize the selection process for oral anticoagulation in patients with AF or VTE, balancing bleeding risk with thrombotic risk reduction
Target Audience
This activity has been designed to meet the educational needs of cardiologists and generalists as well as all other physicians, nurses, physician assistants, nurse practitioners, pharmacists, and all other healthcare providers involved in managing patients with AF and VTE. 
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This activity is supported by an independent educational grant from Pfizer Inc.
Disclaimer
The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Total CME. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to access a site outside of Total CME you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.
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Publication Dates
Release Date: 02/14/2025
Expiration Date: 02/14/2026