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Why do most clinical trials run late? The importance of understanding the impact of uncertainty and risk.
Clinical trials are at the heart of the drug development process. They represent a significant proportion of the total cost and effectively define the critical path to a regulatory submission. Even the most simple study costs over $1m and in the later stages of the development phase they can cost hundreds of millions of dollars and take several years to complete.So why is it that there is widespread agreement across the industry that the vast majority of trials fail to meet their timeline targets? This white paper makes the case that a significant part of the answer may lie in the inability of both
pharmaceutical companies and CROs to get to grips with clinical trial risks and uncertainties. There appears to be an inability to define, understand and incorporate the impact of them and put in place actions to avoid or at least minimise their impact.
