A systematic review of real-world clinical practice data in COVID-19: non-interventional studies
Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.Objective: to describe the feasible and the most sought-...
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| Format: | Article |
| Language: | Russian |
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IRBIS LLC
2022-04-01
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| Series: | Фармакоэкономика |
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| Online Access: | https://www.pharmacoeconomics.ru/jour/article/view/664 |
| _version_ | 1797878877021798400 |
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| author | S. A. Mishinova Yu. M. Gomon A. S. Kolbin V. V. Strizheletsky I. G. Ivanov |
| author_facet | S. A. Mishinova Yu. M. Gomon A. S. Kolbin V. V. Strizheletsky I. G. Ivanov |
| author_sort | S. A. Mishinova |
| collection | DOAJ |
| description | Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection.Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database.Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded.Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic. |
| first_indexed | 2024-04-10T02:40:00Z |
| format | Article |
| id | doaj.art-64e816634c6e4a088fd0b9c4112da2e2 |
| institution | Directory Open Access Journal |
| issn | 2070-4909 2070-4933 |
| language | Russian |
| last_indexed | 2024-04-10T02:40:00Z |
| publishDate | 2022-04-01 |
| publisher | IRBIS LLC |
| record_format | Article |
| series | Фармакоэкономика |
| spelling | doaj.art-64e816634c6e4a088fd0b9c4112da2e22023-03-13T07:48:17ZrusIRBIS LLCФармакоэкономика2070-49092070-49332022-04-0115114516110.17749/2070-4909/farmakoekonomika.2022.099386A systematic review of real-world clinical practice data in COVID-19: non-interventional studiesS. A. Mishinova0Yu. M. Gomon1A. S. Kolbin2V. V. Strizheletsky3I. G. Ivanov4Pavlov UniversityPavlov University; St. George the Martyr City HospitalPavlov University; Saint Petersburg State UniversitySt. George the Martyr City Hospital; Saint Petersburg State UniversitySt. George the Martyr City Hospital; Saint Petersburg State UniversityIntroduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection.Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database.Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded.Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic.https://www.pharmacoeconomics.ru/jour/article/view/664real world dataobservational studiesevidence-based medicinecovid-19coronavirus disease 2019azithromycinhydroxychloroquinesevere acute respiratory syndrometraditional chinese medicine |
| spellingShingle | S. A. Mishinova Yu. M. Gomon A. S. Kolbin V. V. Strizheletsky I. G. Ivanov A systematic review of real-world clinical practice data in COVID-19: non-interventional studies Фармакоэкономика real world data observational studies evidence-based medicine covid-19 coronavirus disease 2019 azithromycin hydroxychloroquine severe acute respiratory syndrome traditional chinese medicine |
| title | A systematic review of real-world clinical practice data in COVID-19: non-interventional studies |
| title_full | A systematic review of real-world clinical practice data in COVID-19: non-interventional studies |
| title_fullStr | A systematic review of real-world clinical practice data in COVID-19: non-interventional studies |
| title_full_unstemmed | A systematic review of real-world clinical practice data in COVID-19: non-interventional studies |
| title_short | A systematic review of real-world clinical practice data in COVID-19: non-interventional studies |
| title_sort | systematic review of real world clinical practice data in covid 19 non interventional studies |
| topic | real world data observational studies evidence-based medicine covid-19 coronavirus disease 2019 azithromycin hydroxychloroquine severe acute respiratory syndrome traditional chinese medicine |
| url | https://www.pharmacoeconomics.ru/jour/article/view/664 |
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