[Harmonization procedures directed toward clinical trials in laboratory medicine at the National Cancer Center Hospital].
Recent advances in pharmacology and molecular sciences made it possible to develop drugs for patients with various maladies. Frustration has existed concerning the delayed provision of these drugs for routine practices in the clinical field. To correct this problem, the importance of clinical trials is increasing. Although there exists a strong demand for participation of clinical laboratories in clinical trials, an awkward attitude in clinical laboratories frustrates those performing clinical trials. We are attempting to correct this problem by introducing our experience with harmonization procedures directed toward clinical trials in laboratory medicine in general. First we described the current status of clinical trials in our hospital. Then we will show personnel in need for clinical trials. Finally we describe in detail our clinical trial procedures. We focus particularly on three aspects of participation in clinical trials: pre-analytical, analytical, and post analytical. Additionally we describe the problems and perspectives in clinical trials by giving special reference to the clinical laboratories in general through discussion with various personnel and specialists. Our goal in the field of laboratory medicine is to benefit patients through the establishment of a harmony between clinical trials and clinical laboratories.
Department of Clinical Laboratory, National Cancer Center Hospital, Chuo-ku, Tokyo 104-0045, Japan.
Mitsuru
M
Ozeki
Kana
K
Shioya
Koh
K
Furuta
D019411:Clinical Laboratory Techniques; D002986:Clinical Trials as Topic / Q000379:methods*; D007564:Japan; D007755:Laboratories, Hospital / Q000458:organization & administration*; D011786:Quality Control