In a trend that has received surprising little attention, contract research organizations (CROs) have gradually taken over much of academia’s traditional role in drug development over the past decade,” thus writes a national correspondent for the New England Journal of Medicine in a perspective published last month. “Commercializing Clinical Trials—Risks and Benefits of the CRO Boom” may not stir the public or medical profession as much as NEJM’s Avandia maelstrom of May, but it is significant that a general medical publication has addressed the CRO industry, although not in a positive light.
The NEJM opinion piece references the large public CROs—Quintiles, Covance, PPD, Charles River Labs, Parexel, and MDS Pharma—with a chart of 2006 revenues garnered from CenterWatch. It further cites the overall growth of the CRO industry, from $7 billion in 2001 to an estimated $17.8 billion today, and a 64% present involvement in Phase I, II, and III clinical trials vs. 28% in 1993.
Establishing that yes, there is a lot of growth in the CRO industry, it lists some tragic events in clinical research in which CROs were involved. From this basis, NEJM offers up that the CRO is sacrificing quality research in the name of speed and the dollar.Accountability comes into question. Do CROs report to the FDA or the sponsor? The FDA itself, apparently, is unclear and would like to clarify this issue. Further, does the sponsor directly squelch out-of-the-box thinking or questioning of a trial’s design by a CRO?
The article claims the CRO workforce is less skilled, less experienced, and less educated than researchers in academia or in pharma, thus compromising quality research. According to the NEJM piece, the CROs pay lower salaries, which result in higher turnover. Also, the nature of the billable hours approach and staff being switched on projects leads to a lack of continuity on each trial, which leads to a lack of expertise or knowledge depth on the specific project.
But these are familiar complaints against the CRO industry. People of all experience and facets in the industry routinely examine the challenges inherent in the outsourced drug development paradigm. In this issue alone, we offer an article regarding sponsors use of preferred providers, and the Inside Outsourcing supplement included with this issue discusses criteria used for CRO selection, as well as outsourced Phase IV trials. Recent industry conference topics include “How to Survive the War Between Cost and Science,” and “CRO vs. Sponsor—The Love Hate Relationship of All Time.” Search actmagazine.com with the keywords “CROs” or “outsourcing.” Many articles describe in detail the NEJM criticisms.
The difference is this is the first time that NEJM takes aim at CROs.
With drug safety constantly at the public forefront and pharma’s apparent inability to respond cohesively, it’s time for our industry to step up and speak up to these issues. Paid registration is required to read the Oct. 4 NEJM article at nejm.org. Even if you just read this summary, click the "Send us your thoughts" link below and submit your views. It’s time to start an industry-wide dialogue.
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