[Clinical trials for gynecological cancers (especially ovarian cancers) in Japan, current situation and problems--focusing on differences in the system of study used by Japanese Study Group and the Gynecologic Oncology Group in the United States].
One of the major problems in treating ovarian cancers at present is how to cure patients with platinum-resistant tumors. Although clinical trials for ovarian cancers in both Japan and the United States have focused on this issue, most Japanese clinical studies in this field have been of poor quality because group studies have not been functioning efficiently. In spite of a tremendous effort, there are several obstacles to overcome before establishing an efficient study group. Keys to perform productive group studies would be as follows: 1) Since most cancer patients in Japan have been treated by physicians whose subspecialty is not oncology, the organization of cancer centers in major local hospitals or the establishment of qualifications for cancer practice is necessary. 2) Because the term "clinical trial" raises the fears of being a "guinea pig" among Japanese, better education of the public, including patients, families, government bodies and even physicians, is necessary to make them understand that only through clinical trials can effective treatment be achieved in the future. 3) Qualification of research nurses and research secretaries is required to save time and make for competent trials. 4) Sufficient government treating is required to keep any commercial bias out of the trials. Finally, 5) strict quality control by the protocol committee of the study groups is mandatory.
Fujiwara
K
K
Dept. of Obstetrics and Gynecology, Kawasaki Medical School.
Kohno
I
I
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic / Q000379:methods; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007564:Japan; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014481:United States
D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin