The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases
Objective: This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries. Methods: Study records that were registered up to December 26, 2018, were extracted from three clinical trial registries (ClinicalTrials.gov, ISRCT...
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| Format: | Article |
| Language: | English |
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KeAi Communications Co., Ltd.
2020-09-01
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| Series: | Global Health Journal |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2414644720300385 |
| _version_ | 1797869765875728384 |
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| author | Marlinang Diarta Siburian Sifa Marie Joelle Muchanga Antonio Fredelindo Dela Resma Villanueva Rianto Setiabudy Iiyama Tatsuo |
| author_facet | Marlinang Diarta Siburian Sifa Marie Joelle Muchanga Antonio Fredelindo Dela Resma Villanueva Rianto Setiabudy Iiyama Tatsuo |
| author_sort | Marlinang Diarta Siburian |
| collection | DOAJ |
| description | Objective: This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries. Methods: Study records that were registered up to December 26, 2018, were extracted from three clinical trial registries (ClinicalTrials.gov, ISRCTN registry, and EudraCT) and a clinical trial register (WHO International Clinical Trials Registry Platform (ICTRP)) with the keyword “Indonesia”. A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed. Results: The top five noncommunicable diseases (NCDs) studied were cancers, diabetes, cardiac diseases, hypertension, and gastrointestinal diseases, while the top five infectious diseases (IDs) were malaria, tuberculosis, vaccines for IDs, HIV, and dengue. Remarkably, the proportion of regional studies (within Indonesia only) was higher than that of multiregional studies (including areas outside of Indonesia) in general. This trend became most apparent after the issuance of national regulations on Material Transfer Agreements (MTA) and other rules. Upon closer scrutiny, regional clinical trials and multiregional clinical trials (MRCTs) in Indonesia differed in terms of sponsorship, target population and size, interventions, and study phases. Conclusions: The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country. Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs. Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials, to better address the national health issues, and to cope with the regulations. |
| first_indexed | 2024-04-10T00:16:45Z |
| format | Article |
| id | doaj.art-8f3f8a97fd874f91abbe835f089db1fb |
| institution | Directory Open Access Journal |
| issn | 2096-3947 |
| language | English |
| last_indexed | 2024-04-10T00:16:45Z |
| publishDate | 2020-09-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | Global Health Journal |
| spelling | doaj.art-8f3f8a97fd874f91abbe835f089db1fb2023-03-16T05:05:27ZengKeAi Communications Co., Ltd.Global Health Journal2096-39472020-09-01438795The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databasesMarlinang Diarta Siburian0Sifa Marie Joelle Muchanga1Antonio Fredelindo Dela Resma Villanueva2Rianto Setiabudy3Iiyama Tatsuo4Department of International Trial, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku, Tokyo 162-8655, Japan; Corresponding author:Department of International Trial, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku, Tokyo 162-8655, JapanDepartment of International Trial, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku, Tokyo 162-8655, JapanDepartment of Pharmacology, Faculty of Medicine, University of Indonesia, Jakarta 10430, IndonesiaDepartment of International Trial, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku, Tokyo 162-8655, JapanObjective: This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries. Methods: Study records that were registered up to December 26, 2018, were extracted from three clinical trial registries (ClinicalTrials.gov, ISRCTN registry, and EudraCT) and a clinical trial register (WHO International Clinical Trials Registry Platform (ICTRP)) with the keyword “Indonesia”. A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed. Results: The top five noncommunicable diseases (NCDs) studied were cancers, diabetes, cardiac diseases, hypertension, and gastrointestinal diseases, while the top five infectious diseases (IDs) were malaria, tuberculosis, vaccines for IDs, HIV, and dengue. Remarkably, the proportion of regional studies (within Indonesia only) was higher than that of multiregional studies (including areas outside of Indonesia) in general. This trend became most apparent after the issuance of national regulations on Material Transfer Agreements (MTA) and other rules. Upon closer scrutiny, regional clinical trials and multiregional clinical trials (MRCTs) in Indonesia differed in terms of sponsorship, target population and size, interventions, and study phases. Conclusions: The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country. Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs. Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials, to better address the national health issues, and to cope with the regulations.http://www.sciencedirect.com/science/article/pii/S2414644720300385IndonesiaClinical trialsMultiregional clinical trialsClinical trial registriesMaterial Transfer Agreement |
| spellingShingle | Marlinang Diarta Siburian Sifa Marie Joelle Muchanga Antonio Fredelindo Dela Resma Villanueva Rianto Setiabudy Iiyama Tatsuo The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases Global Health Journal Indonesia Clinical trials Multiregional clinical trials Clinical trial registries Material Transfer Agreement |
| title | The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases |
| title_full | The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases |
| title_fullStr | The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases |
| title_full_unstemmed | The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases |
| title_short | The progression of clinical trials in Indonesia: an observational study of records from clinical trial registries databases |
| title_sort | progression of clinical trials in indonesia an observational study of records from clinical trial registries databases |
| topic | Indonesia Clinical trials Multiregional clinical trials Clinical trial registries Material Transfer Agreement |
| url | http://www.sciencedirect.com/science/article/pii/S2414644720300385 |
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