ArticleHuman vaccines & immunotherapeutics2021
Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal.
Article in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Willingness to accept paediatric blood sample collection for clinical research purposes in Nepal: a qualitative study.BMJ global health · 2026Article
- The long-term impact of vaccine clinical research on national stakeholders involved: Experience from a low-income Country.Human vaccines & immunotherapeutics · 2025Article
- Knowledge and perception of a clinical trial among the participants: An experience from oral cholera vaccine study in Koshi Province, Nepal.Human vaccines & immunotherapeutics · 2024Article
- Measles-Rubella Microarray Patches Phase III Clinical Trial Framework: Proposal and Considerations.Vaccines · 2024Article
- Expanding Horizons: Increasing Injectable Vaccine in the Expanded Program on Immunization.JNMA; journal of the Nepal Medical Association · 2024Article
- Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal.Human vaccines & immunotherapeutics · 2023Review
- Revisiting the clinical trial history and regulatory mechanisms in Nepal in the context of COVID-19 pandemic.Contemporary clinical trials communications · 2022Review
- Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal.Human vaccines & immunotherapeutics · 2022Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical trials are complicated, time-consuming and costly. From the initial screening, informed consent and recruitment of the participants' to study completion, the sponsor must undertake a wide array of complex and closely monitored operations, complying with international standards for human subject research and local requirements. Conducting these studies in an underdeveloped country, with limited resources, infrastructure, and experience with regulated clinical trials adds to this complexity. The initial site selection, set up and preparatory activities for the clinical trial are crucial to minimizing the risks to both participants and to successful completion during the subsequent study execution.In this paper, we describe the experience and lessons learned of building clinical trial site capacity in terms of infrastructure and human resource development for a Phase III vaccine clinical trial. We believe that sharing the experience of setting up a clinical trial in a resource-limited country will enable other entities contemplating clinical research in these countries, to prepare and plan ahead, to minimize the impact of barriers, and to contribute to bringing more studies to the countries where people live with the burden of vaccine-preventable, poverty-associated diseases.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.