Bayer Pharma AG

Essence of this Article

Registries that record real-world patient outcomes serve many important functions, identifying unmet patient needs and verifying the safety and efficacy of newly introduced therapies. This verification role is important as outcomes in clinical trials may not always reflect what is achieved in practice. Over the past two decades, several major medical registries and non-interventional studies have been launched across many therapy areas in which anticoagulant therapy is used, including: secondary prevention of acute coronary syndrome (ACS); stroke prevention in patients with atrial fibrillation (AF); and prevention and treatment of venous thromboembolism (VTE).

Expanding the real-life knowledge base for thromboembolic disorders

Registries and non-interventional studies that record real-world patient outcomes serve many important functions. Examination of information collected in these studies can identify unmet patient needs and can serve to verify the safety and efficacy of newly introduced therapies. This is important because outcomes in clinical trials may not always reflect what is achieved in practice:

  • Populations enrolled into clinical trials may not truly reflect real-world patients because of inclusion and exclusion criteria
  • Vitamin K antagonists such as warfarin often perform better in clinical trials than in practice (given that their use in clinical trials is more closely monitored and controlled than it is in the routine clinical care setting)
  • Management of bleeding events may be handled differently in clinical trials based on the study protocols

Over the past two decades, several major medical registries and non-interventional studies have been launched across many therapy areas in which anticoagulant therapy is used:

  • Secondary prevention of ACS
  • Stroke prevention in patients with AF
  • Prevention and treatment of VTE

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