Chronic diseases are recognized as a leading cause of mortality, morbidity, health care utilization and cost. A constant tailoring of care to the actual needs of individual patients, complexity and long duration are the distinguishing features of chronic disease management. Given the rapid development and high use of services providing complex management, the number of controlled clinical trials in this field is limited. The information from the few available controlled clinical trials may be difficult to interpret, mainly due to a large variety in the interventions being studied, differences in 'control treatments' and a confined set of outcome measures that are used. The ethical issue with this observation is, that in the absence of randomised clinical trial information on clinical effectiveness and in consequence of the lack of additional data that are crucial for therapeutic decisions in the process of caring, specific patient groups, such as patients with chronic diseases, may become disadvantaged. The scarcity and incompleteness of controlled trial information can partly be explained by difficulties in conducting this type of research in the field of chronic disease management. To avoid that patients with chronic diseases become disadvantaged, the use of alternative designs such as observational studies to evaluate chronic disease management must be accepted and supported. Moreover, in chronic disease management the process of caring needs to emphasized and appraised appropriately. For that purpose, new measurement methods, focussing on concepts of caring that are not included in the majority of current clinical trials, need to be developed.