A trend towards the use of shorter trials with fewer patients to cut the cost and time of developing new drugs is raising concerns about the safety of approved medicines, say US researchers.
A study by Thomas Moore of the Institute for Safe Medication Practices (ISMP) and epidemiologist Curt Furberg of Wake Forest School of Medicine also found that in many instances post-marketing studies that should have been carried out as a condition of early approval remain uncompleted.
Moore and Furberg looked at 20 drugs approved by the FDA in 2008 and compared those given an expedited review by the agency to those approved using the standard review process.
The expedited drugs spent 50% less time in development – an average of 5.1 years versus 7.5 years – and were tested in less than a fifth of the number of patients compared to standard drugs (104 versus 580).
Moreover four years after approval, 60% of commitments made to the FDA on post-marketing studies were unfulfilled, write the authors of the report, which is published in Journal of the American Medical Association (JAMA) Internal Medicine.