The General Clinical Pharmacology “Bias Elimination” Method: Special Workshop—Clinical

The analysis of causality between an adverse event and a medication must include an examination of the sources of bias which may interfere with an appropriate attribu-*** Possible uncontrolled, confusing, or confounding aspects include: patient characteristics (age, gender, nutritional status, and so on), the disease, the medication (over-the-counter as well as alcohol and prescription medications, excipients, colorants, and fillers), the physician observer, and finally, the data about adverse events and the confounding factors. We must also consider the pharmacology of the medication as well as the time factors. The causality of adverse events is best assigned through examination of these data and looking at the concurrence of evidence for or against the causal relationship.