Gan to kagaku ryoho. Cancer & chemotherapy
-
Gan To Kagaku Ryoho · Aug 1998
[Experience as a model hospital for new good clinical practice (GCP) regulations].
The new good clinical practice (GCP) regulations established by the Ministry of Health and welfare aim to promote clinical trials of new drugs that are ethical, reliable, and scientifically sound. According to these regulations, utmost importance should be placed on considerations of trial participant safety, welfare and the protection of his or her human rights. ⋯ These regulations stipulate that a system must be established which makes it possible for a third party to verify the course and conduct of a clinical trial. The new GCP regulations not only set standards for the development of new drugs, they also mark the beginning of a new era in medical science and treatment in Japan.
-
Gan To Kagaku Ryoho · Jul 1998
Review[Prediction of survival of terminally ill cancer patients--a prospective study].
Planning effective palliative care requires accurate estimation of survival. A prospective study was performed on 150 hospice inpatients to identify prognostic factors in terminally ill cancer patients. ⋯ Multiple regression analysis showed that five factors were independent predictors of survival: performance status, dyspnea at rest, appetite loss, edema, and delirium. We discussed current problems and future directions of survival prediction for terminally ill cancer patients.
-
Gan To Kagaku Ryoho · Jul 1998
Review Comparative Study[Differences between Japan and the west in treatment strategy for gastrointestinal cancer--gastric cancer].
Diagnosis, staging, and treatment strategies for gastric cancer were reviewed with regard to differences between Japan and the West. In Japan, detection of early gastric cancer is common due to mass screening and widespread use of endoscopy. Treatment options for gastric cancer vary from endoscopic mucosal resection to the super-extended lymphadenectomy. ⋯ In Japan, D2 lymphadenectomy is the standard, and now a more extended surgery (D4) is being evaluated in a randomized controlled study, while D2 lymphadenectomy has been reported to be associated with high morbidity and mortality in European studies. Adjuvant chemotherapy is more commonly used in Japan, mostly with oral fluorouracil. However, no regimen has been shown effective in the adjuvant setting in either Japanese and Western studies.
-
Endocrine therapy for prostate cancer has been changing rapidly. While LH-RH agonists have been popularly used in medication, their long-acting sustained release formulation is about to be introduced to clinics in Japan. ⋯ In addition, a broader range of endocrine therapies is being studied for treatment of prostate cancer. In terms of treatment methods, a number of attempts are made in selection of subject patients, treatment timing, combination treatment and so on.
-
Gan To Kagaku Ryoho · Apr 1998
[Development of anti-cancer drugs under new renewed GCP--from the viewpoint of drug development company developer].
During the past 7 years since the enforcement of Japan's first GCP in October 1990, various standards and guidelines have been introduced in Japan. On the other hand, the harmonization of GCP has been the subject of major discussion at ICH in order to allow the mutual acceptance of clinical data from different countries. In order to further improve the reliability and consistency of clinical data and the ethics of clinical trials in Japan, the new GCP was enforced in April 1997. ⋯ Before the full enforcement of the new GCP, we, as sponsors of clinical trials, carried out a survey of the current status of clinical trials centering on the reactions of medical institutions to the new GCP, future of clinical trials on anti-cancer drugs in Japan, and differences in time from clinical trials to registration in Japan, the United State and Europe. We sent a questionnaire by facsimile to 21 pharmaceutical companies which have developed or are developing anti-cancer drugs and obtained replies from 20 companies (95%) from August 25 to 30, 1997. This paper reports issues concerning clinical trials on anti-cancer drugs based on the results of our survey.