Jornal de Diabetes Clínica

Abstrato

Clinical Trial Progression in Indonesia: an Observational Study of Records from Clinical Trial Registries Databases

Mario Micheli

This report presents an outline on the progress of clinical tests in land supported information assessment from clinical trial registries. Study records that were registered up to December twenty six, 2018, were extracted from 3 clinical test registries (ClinicalTrials.gov, ISRCTN written record, and EudraCT) and a clinical test register (WHO International Clinical Trials written record Platform (ICTRP)) with the keyword “Indonesia”. a complete of 505 records comprised of 402 interventional studies and 103 experimental studies were found and analyzed. The top 5 noninfectious diseases (NCDs) studied were cancers, diabetes, internal organ diseases, cardiovascular disease, and channel diseases, whereas the highest 5 infectious diseases (IDs) were protozoal infection, infectious disease, vaccines for IDs, HIV, and dengue. Remarkably, the proportion of regional studies (within land only) was beyond that of multiregional studies (including areas outside of Indonesia) normally. This trend became most apparent once the issue of national laws on Material Transfer Agreements (MTA) and alternative rules. Upon nearer scrutiny, regional clinical trials and multiregional clinical trials (MRCTs) in land differed in terms of support, target population and size, interventions, and study phases.