臨床研究教育シンポジウム 治療へと繋がる臨床研究を実施するために
実用化に向けた非臨床開発の基本的考え方
2016 年 33 巻 3 号 p. 453-458
詳細
2016 年 33 巻 3 号 p. 453-458
In Academia, those selected for the ‘Translational Research Center’ of ‘Coordination, Support and Training Program for Translational Research’ by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) or the ‘Clinical Trial Grant Program’ by Center for Clinical Trials, Japan Medical Association (JMACCT) have implemented investigator–initiated clinical trials and started to show remarkable success. This was brought about by government's healthcare policy, which intends to further develop innovative medicinal products (e.g. pharmaceuticals, medical devices, regenerative medicines) by academia until their application in the medical services.
For approval of a medicinal products, it is needed to submit the document composed of quality, non–clinical and clinical study reports to regulatory authorities. However, most Japanese researchers in academia have less knowledge of development medicinal product especially quality and non–clinical strategy. In general, it is difficult to conduct appropriate non–clinical development for medicinal products based only on medical knowledge, and the presence of those with various expertise (e.g. project management, pharmacology, pharmacokinetics, toxicity, regulatory affairs, intellectual property) is essential. Recently, each ‘Translational and Clinical Research Core Center’ to function as an ‘Academic Research Organization (ARO)’ is capable of overall development of medicinal products. Therefore I recommend that the researchers would collaborate with a one of these Core Center or utilize the PMDA consultation on R&D strategy early.
In this report, I will show the non–clinical strategy for conducting clinical trial of a pharmaceutical based on guidelines published by Japanese authority. For example, obtaining non–clinical study results before initiation of first–in human safety trials should be considered in the ICH M3(R2) guideline (guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals).
