Dataset Information

Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe.

ABSTRACT:

Objectives

To describe opportunities and challenges experienced from the four pharmacoepidemiological database studies included in the rivaroxaban post authorisation safety study (PASS) programme and propose ways to maximise the value of population-based observational research when addressing regulatory requirements.

Design

PASS programme of rivaroxaban carried out as part of the regulatory postapproval commitment to the European Medicines Agency.

Setting

Clinical practice in Germany, the Netherlands, Sweden and the UK (electronic health records)-undertaken by pharmacoepidemiology research teams using country-specific databases with different coding structures.

Participants

355 152 patients prescribed rivaroxaban and 338 199 patients prescribed vitamin K antagonists.

Results

Two major challenges that were encountered throughout the lengthy PASS programme were related to: (1) finalising country-tailored study designs before the extent of rivaroxaban uptake was known, and (2) new research questions that arose during the programme (eg, those relating to an evolving prescribing landscape).

Recommendations

We advocate the following strategies to help address these major challenges (should they arise in any future PASS): conducting studies based on a common data model that enable the same analytical tools to be applied when using different databases; maintaining early, clear, continuous communication with the regulator (including discussing the potential benefit of studying drug use as a precursor to planning a safety study); consideration of adaptive designs whenever uncertainty exists and following an initial period of data collection; and setting milestones for the review of study objectives.

SUBMITTER: Brobert G

PROVIDER: S-EPMC10966716 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe.

Brobert Gunnar G Ruigomez Ana A Schink Tania T Voss Annemarie A Herings Ron R Smits Elisabeth E Swart Karin M A KMA Friberg Leif L Balabanova Yanina Y Tarenz Christine C Suzart-Woischnik Kiliana K Soriano-Gabarró Montse M Vora Pareen P Homering Martin M Dyszynski Tomasz T Nagel Gerd G Amaya Pablo P García Rodríguez Luis Alberto LA

BMJ open 20240325 3

<h4>Objectives</h4>To describe opportunities and challenges experienced from the four pharmacoepidemiological database studies included in the rivaroxaban post authorisation safety study (PASS) programme and propose ways to maximise the value of population-based observational research when addressing regulatory requirements.<h4>Design</h4>PASS programme of rivaroxaban carried out as part of the regulatory postapproval commitment to the European Medicines Agency.<h4>Setting</h4>Clinical practice ...[more]

PMID: 38531587

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Dataset Information

Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe.

Objectives

Design

Setting

Participants

Results

Recommendations

Publications

Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe.

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