Current Status of Clinical Trials in Kenya
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Current Status of Clinical Trials in Kenya Ebi Kimanani Drug Information Journal 2002 36: 31 DOI: 10.1177/009286150203600107 The online version of this article can be found at: http://dij.sagepub.com/content/36/1/31
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Drug Informarion Journal, Vol. 36, pp. 31-39, 2002 Printed in the USA. All rights reserved.
0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
CURRENT STATUS OF CLINICAL TRIALS IN KENYA EBI KIMANANI, PHD President, @itendo Statistics Inc., Beaconsfield, Canada
There is a pressing need to reconsider clinical drug development and distribution of medicines in a truly global sense. The majority of people who desperately need medicinal products get only an inadequate portion of all that is manufactured. This paper is an appeal to those in the international drug development arena to include some of the poorest countries in their drug development programs. It is also a challenge to health professionals and regulatory authorities in those countries to upgrade clinical trial procedures in order to meet international standards and to provide other incentives that attract clinical trials from international drug companies. As a case study, the status of clinical research in Kenya is documented. It is shown that the framework for conducting clinical trials exists. Potential sponsors are challenged to seek out clinical trial opportunities in this region in order to benefitfrom the impressive number of excellent health research professionals and large pools of drug-free patient populations. Key Words: Global drug development; Kenya; International Conference on Harmonization Good Clinical Practice; Africa
INTRODUCTION
for these outbreaks are not known yet. They may include some or all of rising human populations and poverty, improper use of drugs and other chemicals, frequent natural disasters, increased prevalence of immunosuppression resulting in rising rates of opportunistic infections, and efficient national and international travel. At the same time, the size of the middle class is increasing. This poses a new challenge of emerging epidemics of noncommunicable diseases and injuries that not very long ago were the “privilege” of affluent societies. Now heart disease, mental illnesses, strokes, and chronic respiratory diseases are fast emerging in low-income countries as the economic level rises and traditional life styles are replaced by riskier ways of life. On the other hand, drug discovery, development, and distribution are
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