**5. Clinical trials in emergency situation and on people suffering from incurable diseases**

In general, clinical trials with patients who require emergency treatment or intensive therapy differ from studies with patients in stable condition. These differences are mostly related to the problem of obtaining informed consent—the patient has blurred consciousness, unresponsive or unconscious, lack of time and opportunity to discover his legal representatives.

Ethical standards and legislation allow informed consent to be missing in cases where the patient's life is in danger, and alternative ways of treating are missing. In all cases, however, the informed consent shall be sought after the performed emergency intervention to continue the participation of the subject in the clinical trial.

If the patient or his/her legal representative does not give consent, he/she has the right to object to the use of data collected from the clinical study.

The situation is different in clinical trials and treatment of deadly diseases. They suggest another category of patients—terminally ill. Such trials are of a great importance, as often there are no alternative types of patients that might be involved due to this is not justified from the ethical stand point.

It should be borne in mind that it is possible terminally ill patients wrongly to suggest that participation in testing is a necessary condition to receive medical care and that it is better to receive any medical care than nothing. Some terminally ill patients consider their participation in the trial as an opportunity to be helpful to others. It is therefore important that they are properly informed and do not participate in the trial based on false assumptions.

Nowadays the topical question is around participation of terminally ill patients in Phase I clinical trials from, as medicines in this phase can be dangerous (e.g. a new kind of chemotherapy). Despite the researcher's willingness to be helpful and give positive results of the tests, the patient may not improve or even get worse. For this reason, it is very important for the patient to be thoroughly informed the potential risks and benefits of the research, without giving unnecessary hope. Study participants must be informed whether their participation or non-participation in the study is a prerequisite for treatment in a hospital, and whether the stay in hospital is at patient's cost.

The AIDS epidemic boosts new kind of demand—access to investigational drugs. Many terminally ill patients are willing to take investigational drugs in a clinical trial because there is no other way to get them—they are either not available or too expensive.

In the United States, there are several examples of treatment use of investigational drugs. In 1976, the 'Group C' treatment was established by agreement between FDA and the National Cancer Institute. The purpose of the programme is to distribute investigational drugs to oncologists to treat cancer under studies outside the controlled clinical trial. Another expanded access concept is so-called Parallel Track policy announced by FDA in April 1992, which permits wider access to new drugs for AIDS/HIV-related diseases [6].

In Europe, 'Compassionate use' programmes allow a medicinal product, without marketing authorisation, to be given to patients with a life-threatening disease when no alternative authorised treatments exist. The European Regulation 726/2004/EC provides directions to 'compassionate use' programmes in the European Union. It states that patients must have a chronic or life-threatening disease, and the medicinal product must be undergoing assessment in a clinical trial or be in the marketing authorisation stage. However, details around authorisation procedures are still missing and ultimately the programmes are governed by individual member states [7].
