ABSTRACT
Patients or healthy subjects can be given checklists of some common events known to occur with the class of drug being tested, and asked to check occurring symptoms. The assessment of adverse reactions in early clinical studies must also take into account whether a certain reaction was present prior to the subject or patient entering the study. The close observation of subjects in early clinical trials is extremely valuable, because the monitor is able to gain first-hand knowledge of adverse events. The physical examination should be thorough and the case report form be detailed enough to capture all clinical information obtained. Leakage of microproteins through the kidney membranes is another such example, where sophisticated laboratory methods are more useful than clinical examination. Great difficulties exist in detecting and assessing adverse reactions in clinical trials. In early clinical trials the pharmacological knowledge becomes important as well as a mind open to analysing unexpected adverse events.
