%0 Journal Article %1 Levenson2013 %A Levenson, Mark S %A Yue, Lilly Q %D 2013 %J Journal of biopharmaceutical statistics %K DeviceApproval DeviceApproval:legislation&jurisprudence DeviceApproval:standards EquipmentSafety EquipmentSafety:standards Humans PharmaceuticalPreparations PharmaceuticalPreparations:adverseeffects PropensityScore RandomizedControlledTrialsasTopic:legislation RandomizedControlledTrialsasTopic:standards ResearchDesign ResearchDesign:legislation&jurisprudence ResearchDesign:standards RCT %N 1 %P 110-21 %R 10.1080/10543406.2013.735778 %T Regulatory issues of propensity score methodology application to drug and device safety studies. %U http://www.ncbi.nlm.nih.gov/pubmed/23331225 %V 23 %X While randomized, well-controlled, clinical trials have been viewed as the gold standard in the evaluation of medical products, including drugs, biological products, and medical devices, it is not uncommon for safety assessment to be performed using observational studies, for ethical or practical reasons. In observational studies, various biases could be introduced in every stage and aspect of study, and consequently the resulting statistical inference may carry a lower level of scientific assurance, compared to randomized trials. To ensure the objectivity of study design and interpretability of the results, it is critical to address the challenges of such studies. In this paper, we share regulatory considerations on the prospective design of observational studies to address safety issues using propensity score methodology. %@ 1520-5711; 1054-3406

@article{Levenson2013, abstract = {While randomized, well-controlled, clinical trials have been viewed as the gold standard in the evaluation of medical products, including drugs, biological products, and medical devices, it is not uncommon for safety assessment to be performed using observational studies, for ethical or practical reasons. In observational studies, various biases could be introduced in every stage and aspect of study, and consequently the resulting statistical inference may carry a lower level of scientific assurance, compared to randomized trials. To ensure the objectivity of study design and interpretability of the results, it is critical to address the challenges of such studies. In this paper, we share regulatory considerations on the prospective design of observational studies to address safety issues using propensity score methodology.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Levenson, Mark S and Yue, Lilly Q}, biburl = {https://www.bibsonomy.org/bibtex/25e897c4b32ccb5709285b79e1db985e1/jepcastel}, city = {US Food and Drug Administration, Silver Spring, Maryland 20993, USA.}, doi = {10.1080/10543406.2013.735778}, interhash = {a6a0ea9a5c411e1e74db18f7a33ccc51}, intrahash = {5e897c4b32ccb5709285b79e1db985e1}, isbn = {1520-5711; 1054-3406}, issn = {1520-5711}, journal = {Journal of biopharmaceutical statistics}, keywords = {DeviceApproval DeviceApproval:legislation&jurisprudence DeviceApproval:standards EquipmentSafety EquipmentSafety:standards Humans PharmaceuticalPreparations PharmaceuticalPreparations:adverseeffects PropensityScore RandomizedControlledTrialsasTopic:legislation RandomizedControlledTrialsasTopic:standards ResearchDesign ResearchDesign:legislation&jurisprudence ResearchDesign:standards RCT}, month = {1}, note = {7227<m:linebreak></m:linebreak>JID: 9200436; ppublish;<m:linebreak></m:linebreak>Propensity score; Normativa}, number = 1, pages = {110-21}, pmid = {23331225}, timestamp = {2023-05-04T08:59:38.000+0200}, title = {Regulatory issues of propensity score methodology application to drug and device safety studies.}, url = {http://www.ncbi.nlm.nih.gov/pubmed/23331225}, volume = 23, year = 2013 }