TY - JOUR
T1 - The progression of clinical trials in Indonesia
T2 - an observational study of records from clinical trial registries databases
AU - Siburian, Marlinang Diarta
AU - Muchanga, Sifa Marie Joelle
AU - Villanueva, Antonio Fredelindo Dela Resma
AU - Setiabudy, Rianto
AU - Tatsuo, Iiyama
N1 - Funding Information:
Moreover, by 2014, the government also encouraged the production of generic drugs by the local pharmaceuticals, particularly to support the implementation of Universal Health Coverage in the country. From the viewpoint of global industries, it might be rather discouraging, since these policies brought the local production of generic drugs competitive advantages in price and distribution. Lastly, the fear that global products are being copied by local industries has also blocked multinational initiatives. Further, as shown in Table 2 , the regulations mostly affected the motivations from the global industries, which resulted in the major drop in their sponsored number of MRCTs during post-MTA (from 101 to 60 studies). Interestingly, it appeared not to affect the global academia/hospital-sponsored MRCTs negatively. On the contrary, an increase to more than double (from 24 to 55 studies) was noted. Based on the records, the latter mostly involved studies targeting IDs and NTDs, amongst which were tuberculosis, malaria, filariasis, and others, and were financed by international funding. Thus, it can be inferred that from the global academia/hospital perspective, despite the regulations, Indonesia remains an attractive site for MRCTs. However, from the global industries’ perspective, such regulations may be seen as hindrances.
Publisher Copyright:
© 2020 People's Medical Publishing House Co. Ltd.
PY - 2020/9
Y1 - 2020/9
N2 - 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.
AB - 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.
KW - Clinical trial registries
KW - Clinical trials
KW - Indonesia
KW - Material Transfer Agreement
KW - Multiregional clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85127981258&partnerID=8YFLogxK
U2 - 10.1016/j.glohj.2020.08.003
DO - 10.1016/j.glohj.2020.08.003
M3 - Article
AN - SCOPUS:85127981258
SN - 2096-3947
VL - 4
SP - 87
EP - 95
JO - Global Health Journal
JF - Global Health Journal
IS - 3
ER -
