[Can the results of clinical trials of pharmacological interventions be transferred into everyday clinical practice?].
Transferability of results originating from randomized, controlled clinical trials is characterized by their external validity. Clinical trials are experimental in their design and conducted under standardized terms, that is, rigorous inclusion and exclusion criteria as well as an artificial trial environment may hamper the transferability of results. Studies designed for approval of new medicines usually exclude elderly patients, multi-morbid patients, pregnant women and children. For example, the median age at diagnosis of colorectal cancer in Germany is 69 (men) and 75 (women) years, respectively. In clinical trials investigating chemotherapy, however, patients above the age of 70 years represent only 18% of the trial population. In cardiovascular trials, especially on acute coronary syndromes, women are usually under-represented. Guidelines derived from clinical trials should therefore explicitly mention a study's limitations. It should be communicated clearly for which patients and under which conditions the guideline is applicable.
Philipp-Klee-Institut für Klinische Pharmakologie, HELIOS Klinikum Wuppertal, Universität Witten/Herdecke. petra.thuermann@helios-kliniken.de
Petra A
PA
Thürmann
D017668:Age of Onset; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D011247:Pregnancy; D015203:Reproducibility of Results