Gan to kagaku ryoho. Cancer & chemotherapy
-
Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. This has been developed since 1970s in the US, by establishing various regulations which are now called GCP. From the viewpoint of total QC, it should be emphasized that rigorous review of protocol by the Institutional Review Board and obtaining Informed Consent are prerequisites for insuring the quality of the given trial at high scientific level. ⋯ Throughout the trial, monitoring and audit are particularly important to assure quality. The sponsor has the responsibility of monitoring the trial and make rigorous onsite visits, and the individual study group also have a monitoring program, while the FDA and the NCI audit by themselves. The purpose of audit is not only to assure data reliability but also to check out patient compliance to drug, education as to regulations and rules of clinical trials and the analysis of violations so as to provide suggestions to improve medical care.
-
Gan To Kagaku Ryoho · Jan 1996
Clinical Trial Controlled Clinical Trial[Clinical evaluation of granisetron hydrochloride against nausea and vomiting induced by anticancer drugs for gynecological malignant tumors].
We, in the Department of Obstetrics and Gynecology, Kansai Medical College, conducted an evaluation of the usefulness and safety of granisetron hydrochloride used for nausea and vomiting due to chemotherapy in patients with gynecological malignant tumors, with an additional study of the efficacy of different regimens. The subjects were 9 patients in whom 16 courses of CAP therapy were given (group A) and 13 patients in whom 24 courses of CAP therapy were given (group B). Granisetron hydrochloride 3 mg/body was administered by intravenous drip in the two groups before chemotherapy. ⋯ In different regimens, the efficacy was 93.8% in group A and 87.5% in group B. These results indicated clinically high usefulness in both groups. No side effects related to granisetron hydrochloride were found in this study.