[对学术界药物研发活动的期望]
[Expectation for the drug development activity in academia].
作者信息
Inagaki Osamu
机构信息
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
出版信息
Yakugaku Zasshi. 2013;133(2):213-9. doi: 10.1248/yakushi.12-00246-6.
Recently many pharmaceutical industries aim at "academic-industrial alliances" to increase opportunities for new drug development. The form of the alliance is mainly a "center-based" one, but recently "open-type" alliance has also become popular. To promote effective collaboration between academia and industries, both parties should obtain clear understanding and support from society through compliance with the social requirement including accountability on the collaborative research and transparency on their relationship. In addition, clinical studies need to comply with the "Ethical Guideline for Clinical Research," or Good Clinical Practice (GCP). Pharmaceutical industries anticipate seeing the deliverables of academic research, and are working on realization of utilizing them in actual medicinal cases.
最近，许多制药行业致力于“产学研联盟”，以增加新药开发的机会。联盟形式主要是“以中心为基础”的，但最近“开放式”联盟也开始流行起来。为了促进学术界和产业界之间的有效合作，双方应通过遵守包括合作研究的问责制和双方关系的透明度在内的社会要求，获得社会的明确理解和支持。此外，临床研究需要遵守《临床研究伦理指南》或《药物临床试验质量管理规范》（GCP）。制药行业期望看到学术研究的成果，并致力于将其应用于实际医疗案例。
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