The opportunities and challenges in conducting clinical trials globally
Abstract
Clinical trials using human subjects are an integral part of the approval of new drugs and biologics. According to Center Watch, 86% of US clinical studies fail to recruit the required number of subjects on time. It is therefore logical that pharmaceutical companies would turn to global outsourcing. Many of these trials are being conducted in developing countries. Accrual in developing countries can be 5–10-times quicker than in the US or Europe. However, clinical trials conducted in other countries differ in many respects. Thus, conducting clinical trials globally raises the concerns of regulatory authorities regarding the transparency, quality, accuracy, and carrying out of these trials following ethical norms. Although clinical research abroad is greatly facilitated by recent efforts to standardize regulatory procedures, and using new technologies has helped to standardize multinational data collection, the issues associated with the globalization of clinical trials still raises concerns about the ethics, adequacy of regulatory supervision of clinical trial, and accuracy and validity of results. This paper examines the impact of the trend being followed globally and presents an analysis of potential ways to capitalize on the associated opportunities while mitigating the challenges in conducting clinical trials globally.
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Subject recruitment is responsible for around 23% of total trial costs.
“Subject recruitment is responsible for around 23% of total trial costs, and 87% of US trials fail to meet temporal recruitment and enrolment milestones [75].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [75]
87% of US trials fail to meet temporal recruitment and enrolment milestones.
“Subject recruitment is responsible for around 23% of total trial costs, and 87% of US trials fail to meet temporal recruitment and enrolment milestones [75].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [75]
Cites
Ethical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710 · see citing works
Trends in the globalization of clinical trials
Thiers, F. A., Sinskey, A. J., & Berndt, E. R. (2007) · Nature Reviews Drug Discovery · doi:10.1038/nrd2441 · Cited by 363 · see citing works
Djakovic-Svajcer, K. (2002) · Medicinski pregled · doi:10.2298/mpns0202005d · Cited by 154 · see citing works
A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness
Bjornsson, T. D., Wagner, J. A., Donahue, S., Harper, D. M., Karim, A., Khouri, M. S., Murphy, W. R. C., Roman, K., Schneck, D. W., Sonnichsen, D. S., et al. (2003) · The Journal of Clinical Pharmacology · doi:10.1177/0091270003256065 · Cited by 141 · see citing works
Emerging ethnic differences in lung cancer therapy
Sekine, I., Yamamoto, N., Nishio, K., et al. (2008) · British Journal of Cancer · doi:10.1038/sj.bjc.6604721 · Cited by 127 · see citing works
Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan
Uyama, Y., SHIBATA, T., Nagai, N., Hanaoka, H., Toyoshima, S., & MORI, K. (2005) · Clinical Pharmacology & Therapeutics · doi:10.1016/j.clpt.2005.04.001 · Cited by 72 · see citing works
High prevalence of drug-induced pneumonia in Japan
Azuma, A. (2007) · Medical Entomology and Zoology · Cited by 55 · see citing works
Ichimaru, K., Toyoshima, S., & Uyama, Y. (2010) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2009.285 · Cited by 52 · see citing works
Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity
Pasquali, S. K., Burstein, D. S., Benjamin, D. K., Smith, P. B., & Li, J. S. (2010) · PEDIATRICS · doi:10.1542/peds.2010-0098 · Cited by 45 · see citing works
Personalizing Cancer Care: American Society of Clinical Oncology Presidential Address 2009
Schilsky, R. L. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.24.6827 · Cited by 36 · see citing works
Hall, J. L., & Dib, N. (2008) · Journal of Cardiovascular Translational Research · doi:10.1007/s12265-008-9046-9 · Cited by 30 · see citing works
Japan Works To Shorten "Drug Lag," Boost Trials of New Drugs
Sinha, G. (2010) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djq017 · Cited by 17 · see citing works
Informed consent: what it is all about.
Shrestha, B. M. (2008) · PubMed · Cited by 5 · see citing works
The Globalization of Clinical Trials
Shin, S.-G. (2002) · Journal of Korean Society for Clinical Pharmacology and Therapeutics · doi:10.12793/jkscpt.2002.10.2.109 · Cited by 5 · see citing works
The Human Factor: Globalizing Ethical Standards in Drug Trials through Market ExclusionPreprint
Khan, F. (2008) · SSRN Electronic Journal · doi:10.2139/ssrn.1123578 · Cited by 4 · see citing works
European drug agency calls for more ethical trials in developing countries
Day, M. (2010) · BMJ · doi:10.1136/bmj.c4984 · Cited by 1 · see citing works
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Barriers for conducting clinical trials in developing countries—A systematic review
Alemayehu, C., Mitchell, G., & Nikles, J. (2018) · International Journal for Equity in Health · doi:10.1186/s12939-018-0748-6 · Cited by 406 · see citing works
- Authors
- Bansal, N.
- Affiliations
- Johns Hopkins University (US)
- Corresponding author
- Bansal, Navneeta
- Venue
- Clinical Research and Regulatory Affairs
- Publisher
- Informa UK Limited
- Published
- 2012-02-09
- Volume
- 29
- Issue
- 1
- Pages
- 9-14
- ISSN
- 1060-1333 (ISSN-L)
- 1532-2521
- OpenAlex
- W2023470500
- Cited by
- 17
- References
- 16
- Citations by year
- 2024: 1 · 2022: 1 · 2021: 2 · 2020: 2 · 2018: 2 · 2017: 1 · 2016: 1 · 2015: 5 · 2013: 1 · 2012: 1
- FWCI
- 2.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Research and Regulatory Affairs (publishedVersion)
- 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
- global clinical trials, clinical trial outsourcing, developing countries, clinical trial recruitment, regulatory oversight, clinical trial ethics, regulatory standardization, pharmaceutical industry
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