A GUIDE TO DRUG DISCOVERY - OPINION The future of drug development: advancing clinical trial design
A GUIDE TO DRUG DISCOVERY - OPINION The future of drug development: advancing clinical trial design
复制标题
DOI：
10.1038/nrd3025
复制
发表时间：
2009-12-01
影响因子：
120.1
通讯作者：
Golub, Howard
中科院分区：
文献类型：
--
作者：
Orloff, John;Douglas, Frank;Golub, Howard
制药行业生产率下降得到了药品开发商、监管机构和患者群体的充分认可。问题的一个关键部分是，由于进行第二阶段和第三阶段试验的成本不断上升，临床研究越来越昂贵。因此，至关重要的是要确保以更有效率和成本效益的方式进行药物开发的这些阶段，并降低自然流失率。在这篇文章中，我们认为，从基于顺序、不同阶段的传统临床开发方法转向更综合的观点，使用适应性设计工具来增加灵活性并最大限度地利用积累的知识，可以在实现这些目标方面发挥重要作用。讨论了这些工具--如贝叶斯方法--在早期和后期药物开发中的应用和实例，以及在更广泛地实施这些工具方面的优势、挑战和障碍。
Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting Phase II and III trials. it is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates are reduced. in this article, we argue that moving from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize the use of accumulated knowledge could have an important role in achieving these goals. Applications and examples of the use of these tools-such as Bayesian methodologies-in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation.