Prospect us

A new cancer treatment is first established after the confirmation of its safety and effectiveness through clinical studies carefully designed based on clinical hypotheses. In Japan, the infrastructure for clinical research is still developing and investigator-initiated or academic multi-institutional clinical studies are needed. Until today, very little concern has been given to the clinical research on palliative care, psycho-oncology, and complementary and alternative medicine. In addition, the standard endpoints to evaluate therapeutic values in clinical studies of these fields has not been well established yet.

One advantage in conducting multi-institutional clinical research is fast patient enrollment and generalisability of the results. On the other hand, it has also disadvantages such as the need of relatively large expenditure on logistics such as data management and communication with/among researchers. However, many of investigator-initiated clinical studies today are conducted solely at one institute because the amount of a research fund one individual investigator could receive is not very large: as a consequence, many clinical studies remain uncontributed to the establishment of a new treatment method.

To support clinical research under the circumstances, we have organized a data center with an operations office and third party committees, endorsed by public research funding and outsourcing and donation from pharmaceutical industry. Dr.Iwase, a physician of department of Palliative Medicine, the Institute of Medical Science, the University of Tokyo, is the cooperator of the data center, who has abundant experiences and accomplishments in both clinical practice and clinical research, especially in the fields of palliative care, psycho-oncology, and complementary and alternative medicine, which is still at an initial stage of development. We allow us to say that we are one of the leading organizations with a plenty of experience and knowledge in these three fields.

①Support for protocol writing

・Biostatisticians (professional statisticians in clinical research) and data managers at the data center and clinician and clinical pharmacists at the operations office give support for protocol writing.
・We share Know-How we collect with individual researchers.

②Quality control of clinical research

・In addition to support for protocol-writing, the data center gives assistance for high quality research: registration and allocation of patients, trial project management, data management, and statistical consideration.

③Operation of third-party committee

・The operations office organizes and operates a protocol review committee which gives a-priori assessment of protocols as well as an independent data monitoring committee which assesses the progress of a clinical trial, the safety data, and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.


Having gained experience, we now give consultations to many researchers about conducting clinical research, not only about research on palliative care, psycho-oncology, or complementary/alternative medicine but also about any research on cancer in general.

Organizing a system and personnel to meet those needs constantly is now imperative: thus we founded a specified non-profit corporation JORTC. Our mission is the establishment of standard cancer treatment and its propagation, which we will substantiate by efficient, intensive, and constant support/promotion of cancer clinical research and by sharing our knowledge openly with both medical specialists and public. We believe our performance will contribute to the promotion for health, medical, and welfare systems.

May 23, 2012
Takuhiro Yamaguchi, PhD, the Director General



Published:2012.12.03
Last updated:2012.12.03

 
 

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