Science Links Japan | Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Clinical Studies Conducted in the U.S.

Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Clinical Studies Conducted in the U.S.

Accession number;99A0225247

Title;Problems in Clinical Tests: What Can Be Done Now and What Should Be Done. Clinical Studies Conducted in the U.S.

Author; MIZUNO KIYOFUMI (Takeda Chem. Ind., Ltd.)

Journal Title;Japanese Journal of Cancer and Chemotherapy

Journal Code:Z0938A

ISSN:0385-0684

VOL.26;NO.2;PAGE.217-224(1999)

Figure&Table&Reference;FIG.4, TBL.4, REF.3

Pub. Country;Japan

Language;Japanese

Abstract;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. (author abst.)

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