New antiepileptic drug trials in developing countries: are they necessary?

Abstract

In recent times, antiepileptic drug (AED) development has expanded with at least seven new AEDs being marketed in a variety of countries. However, in this same period there have been very few trials of new AEDs in the developing world where the majority of people with epilepsy reside. There are many problems with the extrapolation of results from AED trials in developed countries, thus underlining the need for new AED trials in developing countries. This, however, presents a number of ethical and logistical problems, as the majority of people with epilepsy in developing countries are inadequately treated with established drugs. Additionally, there are further problems involving the cost of treatment and the allocation of sparse resources. If trials of new AEDs are to take place in developing countries, strict ethical guidelines must be adhered to, the trials must not be purely marketing exercises, and there must be the continued availability of the new AED to those in the trials who have benefited.