Clinical Trial Registration Process in Nepal
- January 6, 2024
Established under the collaborative efforts of the Nepal Health Research Council (NHRC), Ministry of Health and Population (MoHP) and the World Health Organization (WHO), the Nepal Clinical Trials Registry (NPCTR) endeavors to become the go-to electronic platform for registering clinical trials within the country. It is designed to systematically register and catalog clinical trials conducted within the country.
Since its inception in December 2018, a dedicated 9-member Clinical Trials Registry sub-committee, comprising representatives from WHO, MoHP, the Department of Drug Administration, NHRC executives, secretariat, and staff, has diligently worked towards shaping the registry’s framework.
It operates as an organized system employing observational study methods, systematically collecting standardized data, including clinical and other relevant information. This data collection is focused on evaluating specific outcomes within a defined population characterized by a particular disease, condition, or exposure. All categories of clinical investigations, including interventional trials, observational studies, bioavailability/bioequivalence assessments, and post-marketing research, are recorded and documented within this platform.
Research organization or sponsors are required to create individual accounts on the NPCTR system free of cost, where they submit comprehensive details about their trials, adhering to the system’s specific requirements. Requirements include:
- Clinical Trial Protocol (Proposal)
- Official Ethical Clearance Letter
- Agreement Letter from Study Site
- Researcher Profile
Every clinical trial will undergo independent monitoring by key entities, including NHRC, Ministry of Health and Population, Department of Drug administration and WHO/ICTRP. All clinical trials registered in NPCTR will align with and adhere to the policies and mandates outlined by WHO/ICTRP, positioning the NPCTR as a primary registry in accordance with international standards.
Hence, the registry plays a crucial role in enhancing transparency, accessibility, and accountability in the clinical research landscape of Nepal. By serving predetermined scientific, clinical, or policy purposes, the NPCTR contributes to the overall advancement of medical knowledge, facilitates collaboration, and ensures that critical trial information is available for regulatory authorities, healthcare professionals, and the general public.