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Recommendations toward a human pathway-based approach to disease research
Drug Discovery Today ( IF 7.4 ) Pub Date : 2018-06-02 , DOI: 10.1016/j.drudis.2018.05.038
Lindsay J. Marshall , Christopher P. Austin , Warren Casey , Suzanne C. Fitzpatrick , Catherine Willett

Failures in the current paradigm for drug development have resulted in soaring research and development costs and reduced numbers of new drug approvals. Over 90% of new drug programs fail, the majority terminated at the level of Phase 2/3 clinical trials, largely because of efficacy failures or unexplained toxicity. A recent workshop brought together members from research institutions, regulatory agencies, industry, academia, and nongovernmental organizations to discuss how existing programs could be better applied to understanding human biology and improving drug discovery. Recommendations include increased emphasis on human relevance, better access and curation of data, and improved interdisciplinary and international collaboration.



中文翻译:

关于基于人类途径的疾病研究方法的建议

当前药物开发范式的失败导致研发成本飞涨,新药批准数量减少。超过90%的新药计划失败,大多数在2/3期临床试验阶段终止,主要是由于功效失败或无法解释的毒性。最近的一个讲习班聚集了研究机构,监管机构,行业,学术界和非政府组织的成员,讨论了如何将现有计划更好地应用于理解人类生物学和改善药物发现。建议包括:更加强调与人类相关性,更好地获取和管理数据以及改善跨学科和国际合作。

更新日期:2018-06-02
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