Ethical issues. How can we distinguish clinical research from innovative therapy?

Abstract

The difference between research and innovative therapy is based on the goals rather than the risks or newness of the therapy. The threat to patients from research is not that an untested treatment may be hazardous. Instead, the danger is that the loyalty of their physician may be compromised by the goals of research. In the traditional conception of research, it is assumed that we know what constitutes standard therapy and how effective it is. The goal of research is to compare the effectiveness of an innovation with the standard therapy. However, when rapid progress is being made, it becomes difficult to measure improvements due to introduction of new therapies. It is difficult to determine which of many successful therapies is "best." As a result, rapid progress makes all therapies, including both new ones and old ones, nonvalidated therapies. In such situations, scientific norms about the degree of certainty that we must have in order to judge a therapy as being efficacious are based on the values of the individuals involved; rather than on any value-free statistical or scientific calculations. There are identifiable communities (ethnic groups) that are specifically effected by certain genetic diseases, as well as communities consisting of patients who have certain nongenetic diseases. When these groups (patient advocates) and communities are politically organized, they should be consulted and allowed to participate in the process of devising strategies to evaluate new therapies.