Key result
Clinical research faces a crisis of increasing costs, bureaucracy, and complexity, with industry-led trials averaging 49 enrollment criteria and 158 procedures.
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Design
Editorial
Highlights the increasing bureaucracy, cost, and complexity of clinical trials, suggesting a crisis in clinical research.
Recent publications have indicated that there is a crisis in clinical research. The cost of an industry-led clinical trial is now estimated at some US$100e200 million, within which an average 25 % of centres will recruit no patients. The median number of enrolment (entry) criteria in a drug trial is 49, with a median of 158 different trial procedures. The number of data items per patient often runs into thousands, so it is little surprise that the average time to trial completion increased 70 % between 1999 and 2006.1 There seems to be a self-sustaining ‘industry ’ of bureaucracy around research.
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Tim Coats (2011) reported an editorial. Clinical research faces a crisis of increasing costs, bureaucracy, and complexity, with industry-led trials averaging 49 enrollment criteria and 158 procedures.
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