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GUIDELINES FOR THE EVALUATION OF DRUG PREVENTION INTERVENTION A MANUAL FOR Program PLANNERS AND EVALUATORS Christoph Kroger Hake Winter Rose Shaw IT Institute fur Therapieforschung Munich Germany

It is therefore especially important to develop a quality-assured method of conducting Acts in this field. This paper discusses the methodological issues to be kept in mind when conducting Acts involving new drugs, as they relate to the conduct of epidemiological research. It is also suggested how this study could be extended to non-price areas. 2. What are the major methods for designing a ACT? A ACT was described by Dr David Weber in an article for JAVA in 19931. The main difference to other scientific studies is that it is a randomized controlled trial (see Box 1) that assesses the difference in the incidence of the secondary outcomes between a group receiving the intervention and a control group receiving a similar treatment. Box 1: Key features of Acts Background to ACT Design of a ACT The primary aim of a ACT is to test a hypothesis that will be tested through a statistical analysis. However, not everything can or should be tested in a ACT. This is mainly to allow a control group to be used to compare for comparison with the treatment group. This way the results of the intervention can be observed and the effects of treatment documented. The statistical method used should allow these comparisons to be conducted. If the same trial is conducted at a later stage of the research, results can be compared with results obtained at the earlier stages. The following factors can be taken into account in the design: the length of the trial. the size of the study population the number of trials performed the statistical power of each study 2 What are the basic elements in an ACT? Each step in a ACT has some characteristics: randomization: a procedure to ensure that the patients are assigned to treatment. group assignment to treatment: as defined by a random method such as a block or permute random assignment duration of treatment: the length of time during which the patients will be exposed to the experimental treatment Differences in outcomes between treatment groups over time: outcomes to be measured for each time point (i.e., blood, urine or biochemical markers) over periods of time, usually defined in months. For example, patients with blood plasma analyses performed a month before the study will be assigned to receive the experimental treatment or the control group. All comparisons at each time point are considered significant if their p-value is less than 0.053.

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