[Clinical studies conducted in the U.S].
There are many things that we can learn from the clinical trials conducted in the U.S. They move ahead based on explicit basic principles regarding various matters such as the method for setting up the clinical trial system, selection of CRO, selection of investigators, monitoring activities that are mainly based on their direct access to source documents and sponsor's action when a lack of compliance with GCP occurs. The matters newly introduced in the Japanese new GCP have already been put into practice in the U.S. It is evident that compliance with these standards is ensured in the U.S. by the activities of study coordinators who take greater part in the clinical studies themselves. In order to expedite introduction of the study coordinator system in Japan even just a little, sponsors should consider providing medical institutions with relevant information as well as a chance to educate and train their study coordinators to optimize the function.
Mizuno
K
K
Japan Pharmaceutical Manufacturers Association, Pharmaceutical Development Division, Takeda Chemical Industries, Ltd.
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D014481:United States