Clinical Trial Capacity in East Africa: A Pilot Survey
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Clinical Trial Capacity in East Africa: A Pilot Survey More than 200 medical pnactitioners and dinid researchers in 82 dinical care and research
Ebi Kimononi, PLD' International Biomedical Research in Afnca, Beaconsfield, Canada
Key Words Clinical trials; East Afnca; International Conference on Harmonisation Good Clinical Practice Correspondence Address Dr. Timothy Johns, International Biomedical Research in Afnca, 25 Circle, Beaconsfield.QC H9W 586, Canada (e-mail: [email protected]).
*After this article had gone to press, the Drug Information Journal learned of the death of DKKimanani on January 29,2005.
centers in Kenya, Tanzania, and Uganda responded to a survey on the status of dinical research in h t Afica. 'Zhe d t s showed that: (I) human capaci9 for dinid research exists but needs strengthening; (2) research is hampered @ nonexistent or poor facilities and @ undear regulations and ethical procedures; (3) medical mditioners in most remote sites are wmh$~ed with lmge ofpatients and are isdated f i m research activities; and (4)
INTRODUCTION The argument for strengthening clinical trial capacity in low- and middle-income countries, particularly in Africa, has been made on various fronts. First, it is argued by multiple players that health research in general is a driving force for development and that there are numerous advantages to having research in these countries driven by indigenous scientists and institutions (1,2). One of the many recommendations that have been made on how to strengthen clinical trial capacity is for national governments to make a strong commitment to and provide support for clinical trials (1,2,3). Indeed, without this commitment it is difficult to have a good sense of the long-term sustainabilityof research capacity strengthening efforts, however intensive they may be. In response to this, African leaders, through the New Partnership for Africa's Development, have collectively pledged to ensure that the international development goals in health, economic, education, gender, and environment milestones are achieved by 2015 (4). In particular, the three communicable diseases (HIV/AIDS, malaria, and tuberculosis) top the list of a fast tracked implementation strategy put forward by
above all, lack of political will, funding, and sponsor interest are mqjw obstacles to dinical resemch. Recommendedprim'tiesfor prepming the region for clinical irials should be: regional harmonization of regulatory affairs, ethical p m h , and a Good Clinical hcticeguideline; public educution; and community outreach programs. capacity building efforts in clinical moniton'ng, research site coordination, data management, and biostatistics should be undertaken immediately in order to meet the demand over the next decade.
the authors of the New Partnership for Africa's Development. Second, there are specific advantages of clinical trials which would be immensely beneficial to Africa in many ways. These advantages include the need to determine the region-specific efficacy and toxicity profiles of th
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