South Africa Today - Applied Clinical Trials

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South Africa Today Economical development and regulatory standards make the country a logical choice for trials.

Source: Applied Clinical Trials


Conclusion

In order to conduct responsible, successful clinical trials in South Africa, an understanding of the differences that exist among various populations, including socioeconomic factors, illiteracy, and language and cultural barriers, is crucial. An awareness of the limited education and medical access for many vulnerable populations is also important, especially in light of past studies that have ethically compromised these subject populations. Clinical research can be beneficial for both the sponsor and the participants only when ethical international standards are maintained.

Considering the large and diverse number of subjects that can be recruited for clinical trials in South Africa, it is understandably becoming an important research location. However, along with testing for safe and effective therapies, the opportunity to improve the health status of many patient populations is great. In addition, the large populations devastated by infectious diseases such as HIV, TB, and malaria may greatly benefit from recent drug developments and clinical research being conducted in South Africa.

Finally, according to many investigators, South Africa provides a better environment for trials than many other African nations. So it can serve both as a model for clinical research in Africa and to help improve preventive care.

Karen Politis Virk, MS, is director of biotech and pharmaceutical research at Language Connections, 2001 Beacon Street, Boston, MA 02135, email:

References

1. H.M. Christley, "Conducting Clinical Trials in South Africa," South African Medical Journal, 88, 980-982 (1998).

2. UNAIDS 2008 Report on the Global AIDS Epidemic, http://data.unaids.org/pub/GlobalReport/2008/JC1511_GR08_ExecutiveSummary_en.pdf.

3. Global Campaign for Microbicides in Africa, 2006, a Positive Enabling Environment for Clinical Trials: The Case of South Africa, http://www.global-campaign.org/africa.htm.

4. Fred Hutchinson Cancer Research Center, "South Africa Starts Major HIV/AIDS Trial," News-Medical.Net, http://www.news-medical.net/?id=21812, February 11, 2007.

5. South Africa, The Good News, "SA Aids Vaccine Makes Medical History," http://www.sagoodnews.co.za/south_africa_in_the_world/sa_aids_vaccine_makes_medical_history.html, December 1, 2008.

6. USAID Infectious Diseases Report on South Africa, http://www.usaid.gov/our_work/global_health/id/tuberculosis/countries/africa/safrica_profile.html, October 20, 2006.

7. Ministry of Foreign Affairs of Denmark, http://www.investindk.com/visNyhed.asp?artikelID=14996, 2006.

8. Wellcome Trust, "Potential New TB Vaccine Enters Clinical Trial in South Africa," http://www.wellcome.ac.uk/News/2009/News/WTX054497.htm, April 23, 2009.

9. OneWorld US, "Malaria Vaccine Enters Final Tests," Inter Press Service, UN News Center, http://us.oneworld.net/article/364121-final-phase-malaria-vaccine/, June 5, 2009.

10. Medicines Control Council, http://www.mccza.com/.

11. J.M. Kirigia, C. Wambebe, A. Baba-Moussa, "Status of National Research Bioethics Committees in the WHO African Region," BMC Medical Ethics, 6 (10) (2005), http:// http://www.biomedcentral.com/1472-6939/6/10.

12. http://www.biomedcentral.com/1472-6939/8/1.

13. CIA, The World Fact Book—South Africa, https://www.cia.gov/library/publications/the-world-factbook/geos/sf.html, 2005.

14. Z. Kon and N. Lackan, "Ethnic Disparities in Access to Care Remain in Post-Apartheid South Africa," American Journal of Public Health, 98 (12) 2272-2277 (2008).

15. O. Kloiber and N. Duncan, "New Speaking Book on Clinical Trials Launched for Low Literacy Areas," http://Bizcommunity.com/, http://medical.bizcommunity.com/Article/196/148/29464.html, October 18, 2008.

16. A. Karim and S. Salim, "Globalization, Ethics, and AIDS Vaccines," Science, 288 (5474) 2129 (2000), http://www.columbia.edu/itc/hs/pubhealth/p9408/readings/abdool_karim_2000.pdf.

17. R.B. Weiss, "An On-site Audit of the South African Trial of High Dose Chemotherapy for Metastatic Breast Cancer & Associated Publications," Journal of Clinical Oncology, 19, 2771-2777 (2001).

18. K. Moodley, "HIV Vaccine Trial Participation in South Africa: An Ethical Assessment," Journal of Medicine and Philosophy, 27, 197-215 (2002), http://jmp.oxfordjournals.org/cgi/content/short/27/2/197.

19. R. Shapiro and R. Stein, "Ethical and Legal Issues in AIDS Vaccine Trials," Human Rights, Fall 2004, 20-22.


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