Under the Auspices of the Ministry of Health and Social Welfare of the
Republic of Croatia, Croatian Agency for Medicinal Products and Medical
Devices and Croatian Society for Clinical Pharmacology and Theapeutics
Croatian Medical Association.


Dear Friends and Colleagues,

On behalf of the Organizing Committee of 9th World Congress of Bioethics, it is my pleasure, as the Chair of the Symposium entitled Ethics of Clinical Trials, to invite you to participate in this Symposium and also the Congress in the city of Rijeka, Croatia.

World Health Organization definition of a clinical trial is "Any research project that prospectively assigns human participants or groups to one or more health-related interventions to evaluate the effects on health outcomes." The term "clinical trial" is often used to refer to the use of a drug or a medical device in humans. It is of no doubt that clinical trials are obligatory and necessary in the search of effective treatments and in the process of medical research, discovery and investigation of new drugs for therapy of different medical conditions. A clinical trial, when adequately set, designed, and conducted is certainly an ethically appropriate way to acquire new knowledge. So, it is of utmost importance that clinical trials are conducted in accordance with ethical guidelines and in accordance with legislation. The ethical principle should be the guiding one in the process of designing the clinical trial.

The ethical aspects of clinical trials of special concern could be:

• informed consent and its adequacy nowadays,


• the process of randomization in selection the patients to a treatment group,


• active versus placebo controls,


• ethics committees or institutional review boards and the process of assessing risks and benefits,


• financial and academic pressures as potential ethical conflict,


• the influence or social differences in creating the possibility for double standards in conducting the trials in different countries or parts of the world,


• the preference of physicians or patients to particular treatment, etc

I hope that you will find interesting this Symposium for participating in it and also as an opportunity for discussing different topics in the field of clinical trial ethics. During the rest of the Congress we will also have the opportunity to exchange ideas and to make new, not only professional, but also friendly connections for the future work.

I am looking forward to welcoming you in Rijeka in September 2008.