Clinical Research for CEOs: A guide to good business practice and the conduct of clinical trials.

Regulations do not always provide answers to how best conduct clinical trials. The US's Investigational Device Exemptions (IDEs) and Europe's regulations governing trials to establish device performance in support of obtaining a CE marking (EN 540) give only the sketchiest guidance. Nor are all clinical trials regulated. By stating that trials conducted in support of obtaining a CE marking are subject to EN540, Europe's Active Implantable Medical Directive and Medical Directive leave, by inference, trials conducted for other purposes free from the need to comply with EN540. In the US, IDE's actually provide for exempt clinical trials. In general, such unregulated trials are those conducted on commercial devices used in accordance with approved labelling, trials conducted to determine characteristics other than safety, efficacy or performance, or trials conducted on in vitro diagnostic devices. In these cases the regulations either do not provide guidance or they do not apply at all, and each manufacturer is left to determine how the ethics of good clinical practices will be applied to sponsored clinical research. The following are the most frequently asked about clinical trials.