Background information concerning the topics of the Third Symposium of the IIfTC

"The Methodology of Clinical Hypothesis Testing: Theoretical Foundations and Practical Clinical Problems"

The IIfTC was founded in Bad Orb, West Germany in 1984. Its main purpose is to provide a forum in which traditional and new scientific concepts can be reviewed in a critical and stimulating fashion. In particular, the aim is to bring together researchers with a variety of backgrounds so that important problems can be discussed from different perspectives.

In recent years, randomized clinical trials (RCTs) have gained popularity as a reliable method of testing clinical hypotheses. One standard justification for their superiority over other methods is that they apply the scientific methods to clinical medicine. When doing a clinical trial one has controlled, as far as possible, all the possibly interfering variables, so that the only difference between the groups tested is the treatment in question. Critics of the methodology of RCTs agree that it is reliable as a method for testing a well-defined hypothesis, but have argued that, precisely because of the need for an unequivocal definition of one's population, treatment, and endpoints, RCTs lose their clinical relevance. Furthermore, an important part of the process of acceptance of a hypothesis in the experimental sciences is the ability to replicate the result in different laboratories, under different circumstances. It is, of course, very difficult, both for practical and ethical reasons, to test the same treatment in different trials at different times. There is also a continuing controversy as to the need for randomization. Some have pointed out that if one will accept the result of a trial only if the procedure of randomization has achieved two or more prognostically similar groups, randomization loses its justification as an independent and 'blind' method of achieving control.

Although the above mentioned issues have already been discussed in the literature, there has been little interaction between those researchers who are interested in the foundations of statistics and those who are actively involved in the interpretation of clinical trials. Also, during the last few decades philosophers of science have discussed what the 'scientific method' is in the experimental sciences. Insights developed in this field may now be able to illuminate the controversy over the role of RCTs in clinical hypothesis testing, and also clarify the role of RCTs in clinical medicine. This symposium will therefore be a unique opportunity for discussion between those who are involved in clinical trials, philosophers of science and statisticians interested in the foundations of statistics.

Reidar K. Lie, M.D., Ph.D.
Professor Dr. med. Jochen Schaefer
Kenneth Schaffner, M.D., Ph.D.

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