Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Feb 2007
[Participation to international registration trials--from the investigator's standpoint].
Clinical developments of new anti-cancer drugs in Japan are far behind from the Western as well as Asian countries, which resulted in much delay for indicating them into Japanese patients. The causes of delay are considered to exist in regulatory authorities, pharmaceutical companies, and investigators, respectively. ⋯ A Japan-Korea joint phase I study of new agent for gastric cancer is also now being conducted. It is time for Japanese GI investigators to recover the delay in new drug development and to make an effort for new evidence originated from Japan.
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Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long "White Space" and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas' Phase III data is now usable as pivotal data for NDA submissions. ⋯ It is proposed that Japan take initiative to set up the network such as "Asian Clinical Trial Group" and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.
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Rhabdomyosarcoma (RMS) is the most common type of soft-tissue sarcoma in childhood. In Europe and the United States, survival rates of RMS patients, especially those with local or regional RMS, have dramatically improved from around 25% in 1970 to over 70% in 2001 as a result of the introduction of multimodality therapy and cooperative group trials. ⋯ An analysis of registration data from the Japanese Society for Pediatric Surgery as well as our recent retrospective study indicates that the survival rates of each risk group are all lower than those in the US or Europe, even in the "low-risk" group. We have recently established the Japan Rhabdomyosarcoma Study Group (JRSG) and continued several studies in each risk group to improve the outcome and to establish a standard therapy in Japan.
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Gan To Kagaku Ryoho · Dec 2006
["My tiny windows"--a nurse's point of view--case study from a home palliative care meeting].
In visiting nursing care for home palliative care, nurses should take medical care with a holistic viewpoint. Nurses are not only a daily care provider to clients, but nurses are also necessary to think of themselves as being a person because they are in contact with clients' lives every day. In this home palliative care case, nurses had a chance to intervene with a woman with end-stage-cancer. ⋯ So it was necessary to have meetings frequently to discuss the problem. One of the things we thought was that we had to listen to the client and to watch her expression and behavior very carefully. This case study suggested that nurses should reconsider their practices to improve and to establish their original methods of nursing along with their clients.
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Gan To Kagaku Ryoho · Dec 2006
[Withholding and withdrawing life-prolonging treatment--from the bioethical and legal viewpoints].
In Japan we have not reached an agreement on 'Withholding and Withdrawing Life-prolonging Treatment' among medical, bioethical and legal views. To achieve consensus on this issue, we should take several problems into consideration. They include: (1) Medical judgment; 'Is the patient in the end-stage of illness?' 'Is the futility of the treatment evident?' (2) Autonomy of the patient; 'Is the patient competent?' 'Is the Advanced Directive effective?' 'Is this the decision for the patient's best interest?' (3) Decision making by the family; 'Who is the most appropriate surrogate?' 'Does the decision reflect the patient's values?' or 'Is it for the patient's best interest?' (4) Procedural Justice; Enough communication, enough visibility and respecting the opinions by the third party are important to realize procedural justice. (5) To deliberate the difference between ethical and legal judgment, an interdisciplinary approach should be carried out. (6) To achieve consensus among the people, the importance of an Advanced-Directive should prevail widely.