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States agreed to increase funding for research and development of essential drugs to treat AIDS and other diseases. According to UNAIDS, the number of people receiving antiretroviral treatment in low-and-middle income countries was 3 million at the end of 2007, but this figure represents only one-third of those who are in need of antiretroviral treatment. 36 THE SIZE AND TYPE OF CLINICAL RESEARCH IN AFRICA In the era of globalization, biomedical research involving human participants poses global challenges at many levels. In particular, a growing number of clinical research studies are being conducted in developing countries. Already in 2001, the United States Office of the Inspector General of the Department of Health and Human Services reported that the number of US sponsors conducting drug research abroad had increase 16 times in a decade, from 271 in 1990 to 4,458 in 1999. 37 In our last access, in October 2008, Clinicaltrials .gov 38 listed 62.756 studies being carried out globally. Of these, Africa hosted 1425. Within this number, placebo controlled studies amounted to a total of 521. Most of the studies that included placebo are interventional studies related to check the safety and the effectiveness of certain drugs in reducing the transmission of HIV between partners and from mother to child. Some others are related to the effectiveness of certain drug or product in preventing transmission. Typical in this category are the trials that concern the testing of the effectiveness of vaginal gels to prevent HIV infection in high risk populations (generally sex workers). One, in particular, was a randomized, double-blind, placebo-controlled trial of cellulose sulfate 39 , an HIV-entry inhibitor formulated as a vaginal gel, conducted in 2005 in Benin, Uganda, South Africa and India, involving 1398 women at high risk for HIV infection, which was terminated prematurely due to the evidence in the interim findings, that the cellulose sulfate gel did not prevent HIV infection and may have, in fact, increased the risk of HIV acquisition. This is a typical case where many ethical, legal and human rights issues are at stake and the effective protection of participants’ rights, especially after completion of the trial, is 36 Source: UNAIDS (Accessed at http://www.unaids.org/en/default.asp on December 2008) 37 Rehnquist J., The globalization of clinical trials. A growing challenge in protecting human subjects, Office of Inspector General, Department of Health and Human Services, United States, September 2001, OEI-01-00-00190. 38 http://clinicaltrials.gov (accessed October 2008) 39 Van Damme L., Govinden R., Mirembe F.M. et al., Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission, N.Engl. J. Med., 2008, Vol. 359, No. 5, Pages 463-472 120
Table 5 - Total studies registered in clinicaltrials.gov as of October 2008 Region Name World Africa Central America East Asia Japan Europe Middle East North America Canada Mexico United States North Asia Pacifica South America South Asia Southeast Asia No. of studies 62756 1425 1055 3569 978 14226 2121 38128 5067 845 35400 1007 1984 1717 893 981 Table 6 - Total number of placebo controlled studies registered in clinicaltrials.gov as of October 2008 Region Name World Africa Central America East Asia Japan Europe Middle East North America Canada Mexico United States North Asia Pacifica South America South Asia Southeast Asia No. of studies 15043 521 324 929 297 3920 614 8854 1560 385 8161 477 711 643 368 304 121
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Agenzia Italiana del Farmaco GCP IN
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Table of Contents Authorship and Ac
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World Health Organization - WHO . .
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Annexes - International Round Table
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University of Oxford/Kemri and Well
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- this chapter also contains 42 cou
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UNICRI facilitates global partnersh
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PRESENTATION In welcoming the publi
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3) the existence of centres or rese
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3) the possibility to utilize a lar
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ethical and psychosocial problems i
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CHAPTER I THE INTERNATIONAL GUIDANC
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makers and the community in develop
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therapeutic methods identified by t
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to conduct large-scale trials for v
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preparatory work on a declaration o
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Consequently, these authorities rar
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new scientific developments made ac
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Additional Protocols are foreseen i
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applied in the protection of partic
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Guidelines for Good Clinical Practi
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Ethical and Policy Issues in Intern
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Drug Development Research in Resour
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Educating Bioethics Committees Guid
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processes and stifle competition, d
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European Medical Writers Associatio
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prescribed to more than two million
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Transparency is important both in t
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investments in research”. Current
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identify their needs and to plan fo
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societies. The Foundation also host
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annual, interdisciplinary and inter
Page 70 and 71: project in the respect of internati
Page 72 and 73: also to assess the training needs o
Page 74 and 75: Fogarty International Center for Ad
Page 76 and 77: Global Forum on Bioethics in Resear
Page 78 and 79: the trainees home countries. Based
Page 80 and 81: consolidate it in the fields of edu
Page 82 and 83: KHRC is part of the INDEPTH Network
Page 84 and 85: Research Center on Health, Cultures
Page 86 and 87: Science with Africa The Science wit
Page 88 and 89: exchange in health research ethics
Page 90 and 91: objectives of SIDCER are to foster
Page 92 and 93: national institutions, Tuskegee Uni
Page 94 and 95: The Office for Human Research Prote
Page 96 and 97: esearch, neuro-ethics, good clinica
Page 98 and 99: are TDR (UNICEF/UNDP/World Bank/WHO
Page 100 and 101: committees or scientific advisory c
Page 102 and 103: The objective of the course was to
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Page 106 and 107: as passive recipients or, worse, as
Page 108 and 109: THE HEALTH CARE SCENARIO IN THE DEV
Page 110 and 111: Unfortunately, the “10/90 gap”
Page 112 and 113: about 2,075 molecules were in devel
Page 114 and 115: PATENTING ISSUES AND ACCESS TO ESSE
Page 116 and 117: only on innovative products. A pate
Page 118 and 119: In Africa, especially in the Sub-Sa
Page 122 and 123: very critical and difficult to ensu
Page 124 and 125: The Botswana study was terminated a
Page 126 and 127: THE CAPACITY FOR EDUCATION AND RESE
Page 128 and 129: THE AFRICAN DIASPORA The need for A
Page 130 and 131: with South Africa and Egypt account
Page 132 and 133: Political and social instability, a
Page 134 and 135: 2) Promoting independence from poli
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Page 138 and 139: health care become critical issues.
Page 140 and 141: not yet developed a uniform model f
Page 142 and 143: In order to calculate the percentag
Page 144 and 145: Finally, the analysis was performed
Page 146 and 147: there can be considerable differenc
Page 148 and 149: The diffusion of GCP Inspectorates
Page 150 and 151: Table 5 - List of not analyzed coun
Page 152 and 153: ANGOLA National specific legislatio
Page 154 and 155: BOTSWANA National specific legislat
Page 156 and 157: BURUNDI National specific legislati
Page 158 and 159: 10) République du Cameroun, Minist
Page 160 and 161: CHAD National specific legislation
Page 162 and 163: COTE D’IVOIRE National specific l
Page 164 and 165: EGYPT National specific legislation
Page 166 and 167: EQUATORIAL GUINEA National specific
Page 168 and 169: 8) Mengistie G., Health research et
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GAMBIA National specific legislatio
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http://www.fdbghana.gov.gh/pdf/drug
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GUINEA BISSAU National specific leg
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(Accessed on 9 July 2008 at http://
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MALAWI National specific legislatio
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MAURITANIA National specific legisl
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MOROCCO National specific legislati
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MOZAMBIQUE National specific legisl
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9) neBRA - Networking for Ethics on
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SAO TOME AND PRINCIPE National spec
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SEYCHELLES National specific legisl
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10) Republic of South Africa, Depar
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SUDAN National specific legislation
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TANZANIA National specific legislat
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TOGO National specific legislation
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Conférence Annuelle, 2005 (Accesse
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8) Republic of Uganda, National Hea
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ZIMBABWE National specific legislat
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ANNEXES INTERNATIONAL ROUND TABLE
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c) We recommend the appropriate ide
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AIFA INVITES 1) International and r
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212
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Arab Republic of Egypt, Minister of
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Chong W., China sets up rules to co
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Collier J., Confusion over use of p
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Dramé B., Becker C., Samba Cor Sar
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Federal Democratic Republic of Ethi
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Hamza B., Spécificités et Rôle d
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Japan Pharmaceutical Manufacturers
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Repère Médical, La bioéthique da
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Molyneux C.S., Peshu N., Marsh K.,
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Petrini C. (Ed.), Informed consent
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Republic of South Africa, Medical R
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République Tunisienne, Ministère
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Struble K.A., Toigo T.A., Behrman R
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UNESCO - United Nations Educational
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Varmus H., Satcher D., Ethical Comp
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WHO - World Health Organization, Na
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REC R&D RMTC RBM SARETI SEAICRN TDR
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Biomedical Research in Developing Countries - UNICRI

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