- Vincent Lawton, healthcare consultant and non-executive director
- 1Medicines and Healthcare products Regulatory Agency, London
- Vincent.Lawton{at}btconnect.com
The drug industry is sometimes accused of finding it difficult to reconcile the difference between the strict disciplines of ethical science and its responsibility to its shareholders to return a healthy profit. Proposals to move control of this critical process in drug development into the hands of an “objective” third party need to be critically examined. Clinical trials are properly managed by a rigorous system of regulatory scrutiny throughout. Potential for conflict of interest, when clearly identified and controlled, is not unacceptable.
The industry develops medicines through years of painstaking research by some of the best scientists in the world, often in collaboration with academic researchers. Clinical trials are an essential part of developing safe and effective drugs, and after the drug is introduced to clinical use more is discovered about its effects. Further trials, which can involve academic collaboration, are done to provide further information and study whether new indications can be added to the drug’s use—for example, as in the landmark 4S trial.1
Trial designs and protocols are assessed and endorsed by regulators2 who assiduously guard against inadequate trial design, insist on …
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