Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria
Non-interventional studies (NIS) are conducted to obtain additional information about a medicinal product prescribed in the usual manner in compliance with the conditions determined in the marketing authorization. They are a valuable source of real-world data for the effectiveness and safety of medi...
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| Format: | Article |
| Language: | English |
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Medical University - Pleven
2021-12-01
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| Series: | Journal of Biomedical & Clinical Research |
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| Online Access: | https://jbcr.arphahub.com/article/34602/download/pdf/ |
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| author | Emil Kostov Evgeni Grigorov Hristina Lebanova |
| author_facet | Emil Kostov Evgeni Grigorov Hristina Lebanova |
| author_sort | Emil Kostov |
| collection | DOAJ |
| description | Non-interventional studies (NIS) are conducted to obtain additional information about a medicinal product prescribed in the usual manner in compliance with the conditions determined in the marketing authorization. They are a valuable source of real-world data for the effectiveness and safety of medicines. This study aims to assess physicians‘ knowledge of non-interventional studies in Bulgaria and identify the primary factors and barriers hindering the NIS at a national level. An individual anonymous questionnaire with 16 items was distributed among physicians in inpatient and outpatient settings. The results showed that 81.3% (n=147) of the respondents have no experience with non-interventional studies. Physicians‘ willingness to participate in NIS in the future is high and independent of their previous experience. The main barriers hindering conducting NIS in Bulgaria are related to organization, the conduct and the design of the trials, and, sometimes, the investigators‘ concerns. There is a need for proper training of the researchers and expanding healthcare resources to grow the NIS sector in Bulgaria in line with the tendencies in Europe. |
| format | Article |
| id | doaj-art-06a31d83ad7444cdaf30a2de01e7d124 |
| institution | Kabale University |
| issn | 1313-9053 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | Medical University - Pleven |
| record_format | Article |
| series | Journal of Biomedical & Clinical Research |
| spelling | doaj-art-06a31d83ad7444cdaf30a2de01e7d1242025-08-20T03:35:25ZengMedical University - PlevenJournal of Biomedical & Clinical Research1313-90532021-12-0114214615510.2478/jbcr-2021-001134602Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in BulgariaEmil KostovEvgeni GrigorovHristina Lebanova0Faculty of Pharmacy, Medical University - PlevenNon-interventional studies (NIS) are conducted to obtain additional information about a medicinal product prescribed in the usual manner in compliance with the conditions determined in the marketing authorization. They are a valuable source of real-world data for the effectiveness and safety of medicines. This study aims to assess physicians‘ knowledge of non-interventional studies in Bulgaria and identify the primary factors and barriers hindering the NIS at a national level. An individual anonymous questionnaire with 16 items was distributed among physicians in inpatient and outpatient settings. The results showed that 81.3% (n=147) of the respondents have no experience with non-interventional studies. Physicians‘ willingness to participate in NIS in the future is high and independent of their previous experience. The main barriers hindering conducting NIS in Bulgaria are related to organization, the conduct and the design of the trials, and, sometimes, the investigators‘ concerns. There is a need for proper training of the researchers and expanding healthcare resources to grow the NIS sector in Bulgaria in line with the tendencies in Europe.https://jbcr.arphahub.com/article/34602/download/pdf/clinical trialpost-marketingnon-interventional |
| spellingShingle | Emil Kostov Evgeni Grigorov Hristina Lebanova Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria Journal of Biomedical & Clinical Research clinical trial post-marketing non-interventional |
| title | Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria |
| title_full | Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria |
| title_fullStr | Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria |
| title_full_unstemmed | Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria |
| title_short | Physicians’ Experience and Willingness to Participate in Non-Interventional Trials in Bulgaria |
| title_sort | physicians experience and willingness to participate in non interventional trials in bulgaria |
| topic | clinical trial post-marketing non-interventional |
| url | https://jbcr.arphahub.com/article/34602/download/pdf/ |
| work_keys_str_mv | AT emilkostov physiciansexperienceandwillingnesstoparticipateinnoninterventionaltrialsinbulgaria AT evgenigrigorov physiciansexperienceandwillingnesstoparticipateinnoninterventionaltrialsinbulgaria AT hristinalebanova physiciansexperienceandwillingnesstoparticipateinnoninterventionaltrialsinbulgaria |