Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

@article{Califf2006ClinicalTB,
  title={Clinical trials bureaucracy: unintended consequences of well-intentioned policy.},
  author={Robert M. Califf},
  journal={Clinical trials},
  year={2006},
  volume={3 6},
  pages={496-502}
}
BACKGROUND As randomized controlled trials have become the 'gold standard' for medical research, a complex regulatory structure for the conduct of clinical trials has emerged. However, this structure has not been adequately assessed to ensure that regulations governing human subjects research actually produce the desired effects. PURPOSE Our purpose is to identify some of the major shortcomings in the current regulatory system of human clinical trials oversight, and to propose some potential… CONTINUE READING