Global Health Clinical Trials Programme, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom.
Am J Trop Med Hyg. 2011 Dec;85(6):967-70. doi: 10.4269/ajtmh.2011.11-0151.
We need more clinical trials in the world's poorest regions to evaluate new drugs and vaccines, and also to find better ways to manage health issues. Clinical trials are expensive, time consuming, and cumbersome. However, in wealthier regions these limiting factors are being addressed to make trials less administrative and improve the designs. A good example is adaptive trial design. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to reduce product development times and costs. If this approach makes trials easier and less expensive surely we should be implementing this approach in the field of tropical medicine and international health? As yet this has rarely been proposed and there are few examples. There is a need for raising the awareness of these design approaches because they could be used to make dramatic improvements to clinical research in developing countries.
我们需要在世界上最贫穷的地区开展更多的临床试验，以评估新药和疫苗，并找到更好的方法来处理健康问题。临床试验既昂贵又耗时，而且程序繁琐。然而，在较富裕的地区，这些限制因素正在得到解决，以使试验的管理工作不那么繁重，并改进设计。一个很好的例子是适应性试验设计。这一创新正在被监管机构所接受，并已被制药行业所采用，以减少产品开发的时间和成本。如果这种方法使试验变得更容易、更便宜，那么我们当然应该在热带医学和国际卫生领域采用这种方法？然而，这一方法很少被提出，也几乎没有例子。我们需要提高对这些设计方法的认识，因为它们可以被用来显著改善发展中国家的临床研究。
