E-DRUG: research clinical trials in developing countries (3)
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Dear all,
Wemos and SOMO have recently started a project on ethical aspects of clinical trials in developing countries. We want to get more insight into whether pharmaceutical companies are following existing guidelines on ethical clinical trials. We will focus on issues such as:
Informed consent,
Post trial treatment,
Fair benefits (eg. potential use and future access after drug/vaccine approval),
The use of placebos where alternative treatments are already on the market.
At this moment we focus on Kenya where an inventory study on existing regulations and regulatory bodies is being finalised. In the next stage we would like to carry out an exploratory research on the implementation of the regulations and the ethical standards that are applied in practice in concrete clinical trials in Kenya. The first bottleneck that we face is that we cannot access information to establish a complete overview of clinical trials (ongoing or completed) in Kenya. We would therefore like to know;
Which organisations have carried out similar research in developing countries?
Which methodology did they use?
Do you have suggestions to get access to an overview of all clinical trials being carried out?
Do you have suggestions to detect clinical trials that have not been officially registered?
Do you know recent or ongoing clinical trials in Kenya or other developing countries that might have unethical aspects, but have not been widely exposed?
Please contact:
Annelies den Boer
Project leader access to medicines
Wemos
Annelies.den.boer@wemos.nl
or
Francis Weyzig
Researcher
SOMO
f.weyzig@somo.nl
Annelies den Boer
CSR of pharmaceutical companies/ access to medicines
Please reply to annelies.den.boer@wemos.nl
tel +31-20-4352083
The highest attainable standard of health is a fundamental Human Right.
Wemos Foundation has been working since 1981 to improve people's
health in developing countries through influencing international policy.
Wemos Foundation, P.O. Box 1693, 1000 BR Amsterdam, The Netherlands
tel +31-20-4352050 / fax +31-20-4686008 / web site http://www.wemos.nl
References
1. mailto:Annelies.den.boer@wemos.nl
2. mailto:f.weyzig@somo.nl