[When is a clinical study non-commercial?].
A non-commercial study is a research project not aiming at the protection of a commercial institution's interests. The classification of a clinical study as non-commercial or commercial makes sense and is important especially for clinical research teams, ethics committees and hospital owners because of relevant differences in the image and cost fields. The support of non-commercial studies by commercial institutions like pharmaceutical companies is permissible, unless it is tied to conditions impairing impartiality in respect of design, publication of study results or ownership of the assessed data. Specific relationships between the investigator and a company of the health industry potentially profiting from the study results (e.g. major share holdings or financial dependences) favour the classification of a study as commercial. The reliable classification of a study as non-commercial is only possible if all aids and grants, all conflicts of interest and special agreements are disclosed.
Schimetta
Wolfgang
W
Arbeitsgruppe zur Systemoptimierung klinischer Forschungsprojekte, Institut für Angewandte Systemforschung und Statistik, Johannes Kepler Universität Linz, Linz, Osterreich.
Pölz
Gabriele
G
Pölz
Werner
W
Haring
Hans-Peter
HP
Baumgartner
Holger
H
Aichner
Franz
F
D001317:Austria; D002986:Clinical Trials as Topic / Q000145:classification / Q000941:ethics*; D003132:Commerce / Q000941:ethics*; D016265:Conflict of Interest / Q000191:economics*; D017041:Ethics Committees; D006801:Humans; D010067:Ownership / Q000191:economics; D011786:Quality Control; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic / Q000941:ethics*