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NEJM Takes Shots at CROs

Wednesday, October 31, 2007

A recent New England Journal of Medicine (NEJM) Perspective piece criticized the clinical trials industry for its reliance on contract research organizations (CROs). The piece describes the rapid growth in the CRO industry, questions the quality of research data it generates and cites various clinical trials that have shed some negative light on CRO-run studies.

The article “Commercializing Clinical Trial–Risks and Benefits of the CRO Boom” was written by Miriam Shuchman, M.D., a NEJM national correspondent.

“Given the steady dominance of CROs in the clinical trials domain, the current flaws in the model will need to be remedied. This will require some shift in focus–less single-minded attention to ‘deliverables’ and ‘billable hours’ and greater concern with the discovery of new knowledge,” concluded Shuchman.

Shuchman was unable to be reached for comment at the time of publication.

In the article, Shuchman references two now well-known examples involving CROs: the TeGenero monoclonal antibody study conducted by Parexel in England and the Aventis (now Sanofi-Aventis) trial for the antibiotic Ketek performed by PPD. In both cases, the CROs were found to have acted appropriately and well within regulatory requirements.

Another major point of contention with Shuchman is the industry’s apparent focus on speed and cost-efficiency as opposed to quality data. She notes that CROs have gradually taken over much of the role formerly done by academic institutions.

Doug Peddicord, director of the Association of Clinical Research Organizations (ACRO), strongly disagreed with Shuchman’s criticism of CROs compared with academic centers.

“There is certainly no research that we are aware of that suggest that the number of 483s [FDA Form 483–Notices of Inspectional Findings] or other indicators of difficulties with GCP [Good Clinical Practice] compliance are any different between those two settings,” said Peddciord.

She cites a Tufts Center for the Study of Drug Development report that found CRO-managed projects showed fewer delays than projects that did not use CROs. The 2006 Tufts report also found that those studies did not show a decrease in research quality.

Schuchman went on to question that premise. ACRO’s Peddicord found her argument puzzling.

“To cite a sourced article that says that CROs usage improves the speed of the development process without diminishing the quality of the research and then to go on, in essentially the same sentence, with an unsubstantiated statements from anonymous ‘others’ doesn’t follow basic standards of evidence and is problematic,” he said.

Among myriad of other issues she cites in the piece is that CROs have a high staff turn-over rate during clinical projects, causing the their workforce to be “younger, less skilled, less experienced and less educated” than at pharma companies or within academia.

“Actually, pharmaceutical, biotechnology and CRO employees are drawn essentially from the same personnel pool. And we’re seen a high degree of cross-sector movement all around in recent years,” stated Peddicord. He said the personnel turnover is due to a severe shortage of clinical professionals in both industry and academic institutions, putting experienced workers in high demand.

“There are fewer skilled investigators, skilled monitors and skilled research coordinators than the whole drug development enterprise needs,” he said.

Shuchman suggested that although an alternative model, academic research organizations (AROs), “avoid some of the workforce and qualification problems,” they must compete with CROs for contracts which add pressure to the institutions to conform to sponsor study designs.

According to CenterWatch data, there are few AROs of any size and only one, Duke, that has some ability to conduct the kind of large global clinical trials that are required today. While there are more than 1,000 CROs worldwide, only about a dozen of the largest can conduct trials globally.

“One of the things that we certainly reacted to, in terms of the perspective piece, is the assertion that this kind of specialized expertise has begun to ‘kill clinical research.’ It was absolutely unwarranted and there is no empirical data provided within the article to support that claim,” said Peddicord.

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