Autor: |
Alan Leviton, Tobias Loddenkemper |
Jazyk: |
angličtina |
Rok vydání: |
2023 |
Předmět: |
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Zdroj: |
BMC Medical Research Methodology, Vol 23, Iss 1, Pp 1-10 (2023) |
Druh dokumentu: |
article |
ISSN: |
1471-2288 |
DOI: |
10.1186/s12874-023-02102-4 |
Popis: |
Abstract Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real world evidence are much less expensive than randomized clinical trials that do not rely on “real world evidence” such as contained in electronic health records (EHR). Consequently, we can expect an increase in the number of reports of these types of trials, which we identify here as ‘EHR-sourced trials.’ ‘In this selected literature review, we discuss the various designs and the ethical issues they raise. EHR-sourced trials have the potential to improve/increase common data elements and other aspects of the EHR and related systems. Caution is advised, however, in drawing causal inferences about the relationships among EHR variables. Nevertheless, we anticipate that EHR-CTs will play a central role in answering research and regulatory questions. |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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