Abstract
Abstract How essential is the randomised trial in cancer therapeutics? Is it conceivable that prospective randomised clinical trials in cancer medicine could, one day, safely be abandoned in favour of Phase II studies supplemented with real-world data from cancer centres, without detriment to the progress of cancer therapeutics or the welfare of cancer sufferers? If feasible, such practice could reduce the cost of new drug development, while freeing clinical investigators from the ethical burden of random allocation of treatment or indeed providing no therapy with the administration of a placebo to cancer sufferers.
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