Dr Salim Yusuf (McMaster University, Canada) started his talk by giving an example from his personal experience with the EMERAS/ECLA trials carried out in South America, which demonstrated advantages to carrying out clinical trials in developing countries. This project showed that simple well-organised trials paid off well above expectations. With the help of local staff it resulted in excellent quality data collection and follow-up. It was also the impetus for setting up 'with minimum funding but maximum zeal and determination' other local projects and spin-off studies, data registries, local evidence-based clinical forums and resulted in an overall increase in clinical awareness.
He discussed the large successful high-quality trials carried out in developing countries such as India and China. Conditions there may be simpler and more suitable for certain trials than in other countries, yielding high-quality data. He noted that, although more time was often needed to set up these trials and to train staff, the 'cleanliness' of data and the diligence of follow-up could be at least as good as that of equivalent trials in western countries. This was often due to the enthusiasm and motivation of local staff to address the very real problems existing in their communities.
Yusuf proposed several general issues for consideration when attempting to design international trials involving developing countries:
¿ Is the disease similar in different countries? (Epidemiological data are required to answer this question.)
¿ Is the trial relevant to the country: are the risk factors the same, is the treatment relevant and are the outcomes approximately the same?
¿ Do the culture and infrastructure exist to carry out this trial?
Determining the difference between 'wants' and 'needs', Yusuf felt, is crucial to providing effective health care solutions in a developing country. Western nations should be aiming to improve long-term healthcare in developing countries rather than providing 'quick-fix' short-term solutions. In particular, he mentioned the expansion of clinical research organisations (CROs) into developing countries. It is a damaging influence if they are there simply to carry out trials as cheaply as possible, in order to maximise profits, without real concern for the welfare of the local population.
He made it clear that organisers of trials in developing countries should aim to make the trials as simple as possible, and that it was crucial to understand local conditions: geography, infrastructure limitations, traditions, social organisation and politics, and to aim to work efficiently and sensitively within them. Long-term commitment to the project is essential, as is the understanding that more hands-on input would be needed than in developed countries, at all levels of the project. Researchers should be realistic and prepare for possibly extreme or adverse conditions. Trials in developing countries should not become a new form of neo-colonialism, however; researchers should see their role as helping, guiding and teaching, but not taking control.
In concluding this inspiring and passionate talk, Yusuf urged that trials in developing countries were possible and that the key was in the careful planning of large simple trials.