The Randomized Controlled Trial (RCT) or even better meta-analyses or systematic reviews of several RCTs are considered to be the gold standard for documenting the efficacy of drugs. The RCT has advantages but also disadvantages and other methods for the evaluation of clinical interventions are indeed needed. Clinical pharmacologists have been the pioneers in introducing the RCT and in particular in introducing placebo as control. The RCT is now mastered by clinical intervention researchers in practically all medical specialties and is no longer reserved for clinical pharmacologists. It is difficult to identify particular areas where clinical pharmacologists have a special role in relation to the RCT. It is a method, which all clinical pharmacologists should be familiar with since it still forms the basis of most drug evaluation. One area where clinical pharmacologists could make a difference could be the detection of relatively frequent adverse drug reactions that are predictable and understandable on the basis of the mode of action of the drug.
Another area could be validation of biomarkers as measures of drug action in clinical trials. In clinical pharmacological research, a biomarker could be defined as a characteristic that is objectively measured and evaluated as an indicator of a therapeutic intervention.
We often design our drug metabolism studies as RCT and exploit biomarkers in the shape of experimental pain or pupil measurements.
Clinical Pharmacology in Odense has since 1980 played a central role in a multicentergroup called Danish University Antidepressant Group (DUAG), and we have also been pioneers in research on the use of antidepressants in neuropathic pain. This research is now continued at the Neurology Department N at Odense University Hospital under the leadership of Professor Søren H. Sindrup.
Gram LF; Danish University Antidepressant Group (DUAG). Acute and continuation therapy in unipolar depression: observations from the run-in phase of a maintenance trial. Acta Psychiatr Scand. 2008 Aug;118(2):123-9.Epub 2008 Mar 27.
Otto M, Bach FW, Jensen TS, Brøsen K, Sindrup SH. Escitalopram in painful polyneuropathy: a randomized, placebo-controlled, cross-over trial. Pain. 2008 Oct 15;139(2):275-83. Epub 2008 Jun 10.