Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design
Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an over...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.837632/full |
| _version_ | 1811273071131099136 |
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| author | Lana YH Lai Faaizah Arshad Carlos Areia Thamir M. Alshammari Heba Alghoul Paula Casajust Xintong Li Dalia Dawoud Fredrik Nyberg Nicole Pratt George Hripcsak Marc A. Suchard Marc A. Suchard Dani Prieto-Alhambra Dani Prieto-Alhambra Patrick Ryan Patrick Ryan Martijn J. Schuemie Martijn J. Schuemie |
| author_facet | Lana YH Lai Faaizah Arshad Carlos Areia Thamir M. Alshammari Heba Alghoul Paula Casajust Xintong Li Dalia Dawoud Fredrik Nyberg Nicole Pratt George Hripcsak Marc A. Suchard Marc A. Suchard Dani Prieto-Alhambra Dani Prieto-Alhambra Patrick Ryan Patrick Ryan Martijn J. Schuemie Martijn J. Schuemie |
| author_sort | Lana YH Lai |
| collection | DOAJ |
| description | Post-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance–for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance. |
| first_indexed | 2024-04-12T22:52:25Z |
| format | Article |
| id | doaj.art-88f0b5452bdf4998868c6da1aeec7fb7 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T22:52:25Z |
| publishDate | 2022-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-88f0b5452bdf4998868c6da1aeec7fb72022-12-22T03:13:19ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-03-011310.3389/fphar.2022.837632837632Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study DesignLana YH Lai0Faaizah Arshad1Carlos Areia2Thamir M. Alshammari3Heba Alghoul4Paula Casajust5Xintong Li6Dalia Dawoud7Fredrik Nyberg8Nicole Pratt9George Hripcsak10Marc A. Suchard11Marc A. Suchard12Dani Prieto-Alhambra13Dani Prieto-Alhambra14Patrick Ryan15Patrick Ryan16Martijn J. Schuemie17Martijn J. Schuemie18Division of Informatics, Imaging and Data Sciences, University of Manchester, Manchester, United KingdomDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, United StatesNuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United KingdomMedication Safety Research Chair, King Saud University, Riyadh, Saudi ArabiaFaculty of Medicine, Islamic University of Gaza, Gaza, PalestineReal-World Evidence, Trial Form Support, Barcelona, SpainCentre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, United KingdomFaculty of Pharmacy, Cairo University, Giza, EgyptSchool of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden0Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia1Department of Biomedical Informatics, Columbia University, New York, NY, United StatesDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, United States2Department of Human Genetics, University of California, Los Angeles, Los Angeles, CA, United StatesCentre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, United Kingdom3Health Data Sciences, Medical Informatics, Erasmus Medical Center University, Rotterdam, Netherlands1Department of Biomedical Informatics, Columbia University, New York, NY, United States4Observational Health Data Analytics, Janssen R&D, Titusville, NJ, United StatesDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, United States4Observational Health Data Analytics, Janssen R&D, Titusville, NJ, United StatesPost-marketing vaccine safety surveillance aims to detect adverse events following immunization in a population. Whether certain methods of surveillance are more precise and unbiased in generating safety signals is unclear. Here, we synthesized information from existing literature to provide an overview of the strengths, weaknesses, and clinical applications of epidemiologic and analytical methods used in vaccine monitoring, focusing on cohort, case-control and self-controlled designs. These designs are proposed to be evaluated in the EUMAEUS (Evaluating Use of Methods for Adverse Event Under Surveillance–for vaccines) study because of their widespread use and potential utility. Over the past decades, there have been an increasing number of epidemiological study designs used for vaccine safety surveillance. While traditional cohort and case-control study designs remain widely used, newer, novel designs such as the self-controlled case series and self-controlled risk intervals have been developed. Each study design comes with its strengths and limitations, and the most appropriate study design will depend on availability of resources, access to records, number and distribution of cases, and availability of population coverage data. Several assumptions have to be made while using the various study designs, and while the goal is to mitigate any biases, violations of these assumptions are often still present to varying degrees. In our review, we discussed some of the potential biases (i.e., selection bias, misclassification bias and confounding bias), and ways to mitigate them. While the types of epidemiological study designs are well established, a comprehensive comparison of the analytical aspects (including method evaluation and performance metrics) of these study designs are relatively less well studied. We summarized the literature, reporting on two simulation studies, which compared the detection time, empirical power, error rate and risk estimate bias across the above-mentioned study designs. While these simulation studies provided insights on the analytic performance of each of the study designs, its applicability to real-world data remains unclear. To bridge that gap, we provided the rationale of the EUMAEUS study, with a brief description of the study design; and how the use of real-world multi-database networks can provide insights into better methods evaluation and vaccine safety surveillance.https://www.frontiersin.org/articles/10.3389/fphar.2022.837632/fullvaccine safety surveillancemethods evaluationreal-world datastudy designbias |
| spellingShingle | Lana YH Lai Faaizah Arshad Carlos Areia Thamir M. Alshammari Heba Alghoul Paula Casajust Xintong Li Dalia Dawoud Fredrik Nyberg Nicole Pratt George Hripcsak Marc A. Suchard Marc A. Suchard Dani Prieto-Alhambra Dani Prieto-Alhambra Patrick Ryan Patrick Ryan Martijn J. Schuemie Martijn J. Schuemie Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design Frontiers in Pharmacology vaccine safety surveillance methods evaluation real-world data study design bias |
| title | Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design |
| title_full | Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design |
| title_fullStr | Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design |
| title_full_unstemmed | Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design |
| title_short | Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design |
| title_sort | current approaches to vaccine safety using observational data a rationale for the eumaeus evaluating use of methods for adverse events under surveillance for vaccines study design |
| topic | vaccine safety surveillance methods evaluation real-world data study design bias |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.837632/full |
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