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Real-World Evidence

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:

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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

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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

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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

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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

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