Phase II and III

Unless the drug has proved to be unacceptably toxic, it will then be subject to Phase II, and if successful, Phase III testing. The aim of Phase II trials is to assess the efficacy of the drug. Each Phase II trial will be undertaken in patients with one particular tumour type and they will all be treated with the same dose and schedule. Whist toxicity will continue to be monitored, the patients' disease will also be assessed for response. The aim of Phase III trials is to compare the new agent with existing best treatment for the disease in question.

If a new drug is proven to have an acceptable toxicity profile, efficacy in one or a number of disease types, and to compare favourably against existing standard treatments for the particular disease setting, then the compound may be submitted to regulatory authorities to register it as a product—the culmination of a costly process which can take in the region of ten years to complete.

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