Are ethics being left behind as drug trials go global?

The number of clinical trials being conducted in developing countries has surged in recent years but the legal and ethical frameworks to make them fair are often not in place. This was one of the key messages to emerge from the 7th World Conference of Science Journalists, held in Qatar, last month. In 2008 there were three times as many developing countries participating in clinical trials registered with the FDA than there were in the entire period between 1948 and 2000.  These figures included many “transitional” countries, such as Brazil, China, India, Mexico and South Africa. The attraction for the pharmaceutical industry of doing studies in such countries includes lower costs and the availability of “treatment-naive” patients, i.e. those who have not been previously exposed to other drugs or enrolled in other studies. For developing countries, the main incentive for involvement with clinical trials is the promise of advanced medical science and access to the latest medications. However, the process of establishing and enforcing a legal and ethical framework to protect study participants is not always keeping pace. While many countries have set ethical standards for clinical trials, they are not always being followed, by either the sponsor or the investigator. “Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding,” said Professor Ames Dhai, Director of the Steve Biko Centre for Bioethics, South Africa. The conference noted that in places such as South Africa, where it’s mostly poor people with low literacy levels and a culture to accept authority without question, there is the potential for ethical misconduct.  “The greatest challenge in moving to mutual benefit is balancing the needs of biomedical research with the full protection of research participants and communities,” said Dhai. If this can be achieved, clinical trials can be highly beneficial for developing countries.  Not only will patients get access to life-saving drugs, the research itself can be used as a platform to enhance local skills, build genuine partnerships with the pharmaceutical industry, and attract funds to develop appropriate programs. Have you sponsored or participated in clinical studies in the emerging world? Share your experience with us.