The volume of research conducted in Europe will be driven down dramatically, and thousands of lives will be lost, if a directive developed by the EU becomes law next year, warned leading UK research directors last week. If it becomes law it will have a most destructive effect on research and will mean that many people in Europe will die unnecessarily because it will be an obstacle to finding how to save lives. For example, researchers looking at chemotherapy will be expected to report every incidence of diarrhoea despite the fact that anti-cancer drugs are renowned for this side effect, according to Professor Gray. This kind of demand means that someone is going to be inundated with totally worthless reports. The ICH, which is made up of specialists from the pharmaceutical industry and drug regulatory bodies in the US, Europe and Japan, developed their guidance on clinical trials to assist companies seeking the registration of new drug entities, or those which are not yet licensed.
Clinical trials are already too complex, agree research leaders.
Patients and medical staff are quite often deterred from taking part in trials because of the extra workload, tests and investigations involved. This means that trials take longer to perform. The knock-on effect is that the approval of new medicines is delayed, as is guidance on treatment options for doctors at the frontline. Because they are investing large sums of money into the trials they want to gather as much information as possible about patients and their treatment, said Professor Gray. But there's a catch.