The future of controlled clinical regulatory trials

It is one thing to endorse the aim that only safe and effective drug products should be used, but quite another to sustain a robust societal consensus about the precise means and methods to secure this aim. It would be misleading to end this chapter without acknowledging the continuing controversy concerning the role of government in monitoring the drug supply. Much of the controversy stems from the fact that virtually any substantive system of drug regulation must, by dint of the tests and requirements it imposes, lengthen the time required for an effective and reasonably safe drug to move from the 'bench to the bedside'.

Regulation also undoubtedly increases the costs of drug development and can discourage commercial drug discovery and development. On the other hand, without regulation ineffective and dangerous drugs would be available and this would impose unreasonable costs on society. The boundaries between reckless permissiveness, reasonable control, and excessive rigidity are not settled. Nor is there common agreement as to the preferred means for a regulatory system to exercise its powers. Not surprisingly, views on these matters are based more on personal sentiments and values than on findings of fact or scientific principles. Drug regulation, although it employs the tools of science and medicine, is ultimately a political instrument, subject to the vicisssitudes of the political process, and those interested in controlling the quality of the drug supply have little choice but to become active participants in this process.

The evaluation of evidence from clinical trials is considered further in Chapter6..1.1.2.

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