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The drug development enterprise has had two years of unprecedented levels of innovation at the same time that operating conditions have intensified. A growing number of companies are planning and piloting rich data and analytic solutions and new study conduct models to address high and rising development costs, increasing scientific and operating complexity, high levels of risk, inefficiency and fragmentation.
The expedited approval pathways implemented by the FDA in the past 30 years have shortened many drugs’ road to market, but a new study from Harvard University researchers questions whether the time saved outweighs the risks of approving new drugs without putting them through the traditional clinical trial process.
