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Real-World Evidence
In this section:
Expanding real-world knowledge
Clinical trials have defined study protocols and strict patient inclusion and exclusion criteria. As a result, outcomes of clinical trials may not always fully reflect outcomes in routine clinical practice. Registries and non-interventional studies serve many important functions including:
- Identifying unmet patient needs
- Verifying the safety and efficiency of newly introduced therapies
- Providing information on the management of adverse events, e.g. bleeding, in routine clinical practice
- Understanding of treatment patterns
Several major medical registries and non-interventional studies have been launched in therapy areas in which anticoagulant therapy is used, including:
Real World Evidence and Claims Databases – a Guide for Healthcare Professionals
Prof. Craig I. Coleman gives an appreciation of the methodology used to perform Real World Evidence studies, particularly those investigating the effectiveness and safety, of non-vitamin K antagonist oral anticoagulants (or NOACs) in non-valvular atrial fibrillation patients. He also provides some key insights on what real world evidence and specifically claims databases can - and cannot - tell us. Approval number: PP-XAR-ALL-0036-2
From ROCKET AF to real-world evidence
The results of the ROCKET AF study assessing rivaroxaban compared with warfarin in patients with NVAF for the presentation of stroke are similar to non-interventional studies with rivaroxaban in the same patient population
© 2017, Bayer AG. All rights reserved. Approval number: PP-XAR-ALL-0097-2
From EINSTEIN to real-world evidence
The EINSTEIN clinical trial programme showed similar outcomes to real-world interventional study (XALIA) for the treatment of patients with VTE
© 2017, Bayer AG. All rights reserved. Approval number: PP-XAR-ALL-0092-1
XANTUS pooled: global rivaroxaban use in real-world patients with non-valvular atrial fibrillation
The XANTUS programme evaluated the safety and efficacy of rivaroxaban in real-world patients with NVAF across the globe
© 2017, Bayer AG. All rights reserved. Approval Number: PP-XAR-ALL-0639-1
Copyright © Bayer AG |
- PP-M_RIV-ALL-0168-1
Updated date 10/10/2022
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