Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors
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| Format: | Artículo Open Access |
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Wiley
2024
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| _version_ | 1867013146090143745 |
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| author | Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss |
| author_facet | Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss |
| collection | Wiley Open Access |
| contents | Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss Pharmacoepidemiology and Drug Safety AbstractDirect oral anticoagulants (DOACs) revolutionized the management of thromboembolic disorders. Clinical care may be further improved as Factor XIs undergo large‐scale outcome trials. What role can non‐randomized database studies play in expediting understanding of these drugs in clinical practice? The RCT‐DUPLICATIVE Initiative emulated the design of eight DOAC randomized clinical trials (RCT) using non‐randomized claims database studies. RCT study design parameters and measurements were closely emulated by the database studies and produced highly concordant results. The results of the single database study that did not meet all agreement metrics with the specific RCT it was emulating were aligned with a meta‐analysis of six trials studying similar questions, suggesting the trial result was an outlier. Well‐designed database studies using fit‐for‐purpose data came to the same conclusions as DOAC trials, illustrating how database studies could complement RCTs for Factor XI inhibitors—by accelerating insights in underrepresented populations, demonstrating effectiveness and safety in clinical practice, and testing broader indications. 10.1002/pds.5813 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| doi_str_mv | 10.1002/pds.5813 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_pds_5813 |
| institution | Wiley Open Access |
| license_str_mv | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss Pharmacoepidemiology and Drug Safety Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors Shirley V. Wang Kueiyu Joshua Lin Sebastian Schneeweiss Pharmacoepidemiology and Drug Safety AbstractDirect oral anticoagulants (DOACs) revolutionized the management of thromboembolic disorders. Clinical care may be further improved as Factor XIs undergo large‐scale outcome trials. What role can non‐randomized database studies play in expediting understanding of these drugs in clinical practice? The RCT‐DUPLICATIVE Initiative emulated the design of eight DOAC randomized clinical trials (RCT) using non‐randomized claims database studies. RCT study design parameters and measurements were closely emulated by the database studies and produced highly concordant results. The results of the single database study that did not meet all agreement metrics with the specific RCT it was emulating were aligned with a meta‐analysis of six trials studying similar questions, suggesting the trial result was an outlier. Well‐designed database studies using fit‐for‐purpose data came to the same conclusions as DOAC trials, illustrating how database studies could complement RCTs for Factor XI inhibitors—by accelerating insights in underrepresented populations, demonstrating effectiveness and safety in clinical practice, and testing broader indications. 10.1002/pds.5813 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| title | Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors |
| topic | Pharmacoepidemiology and Drug Safety |
| url | https://onlinelibrary.wiley.com/doi/10.1002/pds.5813 |