Clinical trials developing countries

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

In recent years in some developed countries, the requisite of presenting economic evaluation (that is, pharmacoeconomic) studies of new dmgs has been introduced alongside the existing one of clinical trials. These studies have to provide proof of their efficiency (or cost-effectiveness) as a condition for the public financing of the new product. These studies improve information and market transparency and may help to make competition keener, but like the earlier requirements regarding effectiveness and safety, they constitute an additional cost factor and as such raise further barriers to entry. 

Supply on a particular patient basis encompasses various categories of unauthorised use of medicinal products. A product maybe imauthor-ised because it has been specially formulated for use it may be at the clinical trial stage of development, but be requested by doctors for use outside a trial it may have been authorised previously and then withdrawn from the market for commercial reasons, or because of safety, efficacy or quality concerns or it may be authorised currently, but for a different indication or patient population, or in a different country. 

In the past 25 years, anecdotal reports of beneficial effects in MS sufferers of smoking Cannabis (the herb or resin of Cannabis sativa L.) have resulted in a considerable amount of research and interest from academia, industry and government. Several products containing cannabis extracts or carefully standardized mixtures of constituents are in development with a number of clinical trials being carried out. In a few countries, products... 

Clinical trials of ARIs have yielded encouraging results in alleviating painful symptoms of diabetic complications. However, unacceptable side effects related to toxicity or inadequate pharmocokinetic profiles have rendered most of the drug candidates undesirable. Nevertheless, several ARIs are commercially available in some countries and more appear to be in the pipeline. The therapeutic rationale for treatment of human diabetics with ARIs to delay or prevent onset of diabetic complications is compelling. Animal models with experimentally induced hyperglycemia develop complications that are morphologically and functionally similar to that seen in the human diabetic patient. Many structurally... 

The U.S. NBAC, CIOMS, and WMA all say that therapeutic studies should benefit the community where the research is done in exchange for their cooperation and to avoid exploitation. Affable advice such as "Clinical trials conducted in developing countries should be limited to those studies that are responsive to the health needs of the host country" (NBAC 2001) is insufficient to redirect First World researchers to priorities, products, or benefit sharing that benefits developing countries where First World research is conducted (Kass and Hyder 2001 NBAC 2001 Kass, Dawson, and Loyo-Berrios 2003). 

Research Clinical Trials in Developing Countries. Bethesda, MD NBAC. Available at http //www. georgetown.edu/research/nrcbl/nbac/clinical/Voll.pdf [Accessed January 12, 2006]. 

Tomas, J. 1998. Ethical Challenges of HIV Clinical Trials in Developing Countries. Bioethics 12 325-326. 

In terms of the new MAO inhibitors that may become available in the future, it is possible that some new RIMAs may be approved as antidepressants. Moclobemide, available in many countries, is unlikely, for commercial reasons, to become available in the United States. Another promising RIMA, brofaramine, is also unlikely to be developed for any country. However, befloxatone is progressing in clinical trials, and other RIMAs are also potential drug development candidates, including RS-8359, cimoxatone, and toloxatone. 

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