c6225b654d9e3b1b5a5eb7f1bee05d4a pmc_10672708.pdf be59e02ae9b83c61cf4d78a071a704ecf6035062 pmc_10672708.pdf 236691b0edb040efdf34a7451a7d44a7e98761cd8dca8f4777f8cf07cdb49275 pmc_10672708.pdf Title: Pharmacoepidemiology: An Overview Subject: The aims of this review are to provide a comprehensive overview of the definition and scope of pharmacoepidemiology, to summarize the study designs and methodologies used in the field, to discuss the future trends in the field and new methodologies to address bias and confounding, and finally to give some recommendations to clinicians interested in pharmacoepidemiologic research. Because drug efficacy and safety from randomized clinical trials do not reflect the real-world situation, pharmacoepidemiological studies on drug safety monitoring and drug effectiveness in large numbers of people are needed by healthcare professionals and regulatory institutions. We aim to highlight the importance of pharmacoepidemiologic research in informing evidence-based medicine and public health policy. The development of new designs and methodologies for the generation of valid evidence, as well as new initiatives to provide guidance and recommendations on how to incorporate real-world evidence into the drug development process, are reported on. In addition, we have touched on the implication of artificial intelligence in the management of real-world data. This overview aims to summarize all important aspects to consider when conducting or interpreting a pharmacoepidemiologic study. Keywords: pharmacoepidemiology; effectiveness; pharmacovigilance; regulatory decision; adverse drug reaction; drug safety; patient safety Author: Mònica Sabaté and Eva Montané Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Fri Nov 10 11:38:00 2023 CET ModDate: Fri Nov 10 11:39:41 2023 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 635189 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- LZJWOX+VnURWPalladioL Type 1 Custom yes yes no 10 0 RGYTMY+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 NQRZQX+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 PVCXAY+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 WEQVKZ+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 46 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 49 0 FPNOPX+PalatinoLinotype,Italic CID TrueType Identity-H yes yes yes 76 0 FPNOPX+PalatinoLinotype,Bold CID TrueType Identity-H yes yes yes 82 0 FPQQCW+PalatinoLinotype CID TrueType Identity-H yes yes yes 88 0 NUUXUW+VnURWPalladioL-Italic Type 1 Custom yes yes no 123 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-06-12 02:44:13 CEST RepresentationInformation: pmc_10672708.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-06-06 02:38:31 CEST Size: 635189 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 362 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Pharmacoepidemiology Definition and Objectives Destination: section.2 Item: Title: Studies in Pharmacoepidemiology Destination: section.3 Item: Title: Sources of Data Collection Destination: section.4 Item: Title: Measures to Avoid Biases and Confounding Factors Destination: section.5 Item: Title: Using Observational Data for Regulatory Decisions Destination: section.6 Item: Title: Conducting and Reporting Pharmacoepidemiologic Research Destination: section.7 Item: Title: Recommendations Destination: section.8 Item: Title: Conclusions Destination: section.9 Item: Title: References Destination: section.10 Info: Title: Pharmacoepidemiology: An Overview Author: Mònica Sabaté and Eva Montané Subject: The aims of this review are to provide a comprehensive overview of the definition and scope of pharmacoepidemiology, to summarize the study designs and methodologies used in the field, to discuss the future trends in the field and new methodologies to address bias and confounding, and finally to give some recommendations to clinicians interested in pharmacoepidemiologic research. Because drug efficacy and safety from randomized clinical trials do not reflect the real-world situation, pharmacoepidemiological studies on drug safety monitoring and drug effectiveness in large numbers of people are needed by healthcare professionals and regulatory institutions. We aim to highlight the importance of pharmacoepidemiologic research in informing evidence-based medicine and public health policy. The development of new designs and methodologies for the generation of valid evidence, as well as new initiatives to provide guidance and recommendations on how to incorporate real-world evidence into the drug development process, are reported on. In addition, we have touched on the implication of artificial intelligence in the management of real-world data. This overview aims to summarize all important aspects to consider when conducting or interpreting a pharmacoepidemiologic study. 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