Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

CLINICAL TRIALS AND DEVELOPING COUNTRIES, ETHICAL CODNSIDERATIONS

P Phanuphak
Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 8.2
AIDS 1994, Vol. 8 (Suppl. 4);S7

Clinical trials are as important and needed in developing countries as in developed countries. The trial will answer such questions as acceptability, feasibility, sustainability and the possible side-effects of a particular intervention in a specific culture and locale. The trial can be tailored to the need of a specific group of population. The trial will provide the active drug to at least half of the subjects who otherwise might have no chance for the treatment at all. Clinical trial provides training opportunity in good clinical research practice for investigators in the developing country as well as the opportunity for laboratory strengthening. At the same time, some trials which cannot be done in developed countries may still be possible in the developing countries. This comes the ethical issue.

The followings list some important ethical issues that need to be considered in conducting clinical trials in developing countries: (1) Should a product from a developed country which has never been tested in the country of origin be allowed for testing in developing countries? (2) Which local or international ethical committees that the investigator should get approval from and to whom that the investigator can appeal? (3) Haw can the ethical guidelines be universally standardized in view of the cultural and political differences? (4) Should a product which will never be affordable in the developing country be tested in that country? (5) Should a study design which includes a placebo arm which is no longer allowed in the developed country be allowed in the developing countries? (6) Is written consent form mandatory and how extensive should it be? (7) How to make the trial equally accessible by all minority groups in the society? (8) Should the active drug in the trial be made available to all volunteers as long as needed beyond the trial period? (9) How to best monitor the ethical aspect of the trial? (10) How can the trial benefit the local scientists to the same extent that it will benefit the collaborating scientists from the developed countries? (11) How will the trial benefit the host country as a whole? (12) How will the host country handle the demand of the trial product from all other patients in the country once proved effective?

There is no easy answer to these Questions. We have to make the best out of these controversial ethical issues so that clinical trials can be immediately started in developing countries in order to benefit the country itself as well as to add important information to the global scientific knowledge.

Presenting author: P Phanuphak

1994-11-18
8.2

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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