Regulatory Challenges Associated with Conducting Multicountry Clinical Trials in Resource-Limited Settings
Open accessAbstract
International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.
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Regulatory processes in resource-limited countries hinder efficient implementation of multi-site clinical trials, delaying research and costing millions of dollars a year.
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From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [60]
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- Authors
- Ndebele, P., Blanchard-Horan, C., Shahkolahi, A., & Sanne, I.
- Affiliations
- University of the Witwatersrand (ZA)
- AIDS Clinical Trials Group (US)
- Corresponding author
- Ndebele, Paul
- Venue
- JAIDS Journal of Acquired Immune Deficiency Syndromes
- Published
- 2014-01-01
- Volume
- 65
- Issue
- Supplement 1
- Pages
- S29-S31
- ISSN
- 1525-4135 (ISSN-L)
- PMC
- PMC3900239
- OpenAlex
- W2088506144
- Cited by
- 46
- References
- 10
- Citations by year
- 2026: 13 · 2025: 7 · 2024: 8 · 2023: 2 · 2022: 5 · 2021: 3 · 2019: 2 · 2018: 1 · 2017: 3 · 2016: 1
- FWCI
- 0.34
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAIDS Journal of Acquired Immune Deficiency Syndromes (publishedVersion, public-domain)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (U01AI069463, UM1AI069463)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- regulatory challenges, resource-limited settings, drug approval, research ethics committees, regulatory delays, infectious disease research
- MeSH terms
- Clinical Trials as Topic, Drug and Narcotic Control, Health Resources, Humans, International Cooperation, Public Health, Multicenter Studies as Topic, HIV Infections, Guidelines as Topic, Ethics Committees, Clinical, Ethics Committees, Research
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