Workshop: Pitfalls in conducting rendomized clinical trials

To ultimately assess the efficacy of (new) drug treatments, compounds have to be tested in humans. However, drugs may well have only moderate improvements in disease outcome. Nevertheless, a moderate improvement of survival in a common disease may save thousands of lives each year. It is therefore important to get reliable answers, which calls for carefully designed studies. Randomized clinical trials are generally perceived as the study design to obtain the most reliable results about the efficacy and safety of new treatments. In these trials the effects of different pharmacological agents are compared to each other by offering different treatment regimes to patients ‘at random’. This provides the opportunity to compare treatment effects in a fair and ‘unbiased’ fashion. However, interpretation of the data may be less simple than it seems.

This workshop will provide an introduction to the area of clinical trials and covers some of the key issues to be considered in conducting clinical trials. Specific attention will be paid to design and methodological issues of randomized clinical trials, numbers needed to treat, need for control groups, surrogate endpoints, and ethical issues. During the workshop participants will be asked to critically address major issues in the reporting of a clinical trial evaluating the efficacy of a new drug in protecting from cardiovascular disease.

This workshop is of particular importance for all students who are interested in Clinical Medicine and would like to gain more insight into how to conduct clinical trials.