Contract research organizations (CROs) provide substantial global capacity to drug developers and have become a critical contributor to clinical trial activity, according to the results of a study released by the Tufts Center for the Study of Drug Development. The study was based on an analysis of 83 NDAs and BLAs submitted to the FDA between 2000 and 2005.

The study found that drug sponsors who use CROs more extensively complete projects faster, particularly during the study close-out period, while maintaining quality comparable to submissions involving minimal use of CROs. In addition, projects involving more use of CROs are typically submitted more than 30 days closer to the projected FDA submission date than low CRO usage projects.

In 2004, the most recent year for which data are available, leading CROs managed nearly 23,000 Phase I-IV studies at 152,000 clinical sites worldwide. “The results of our study challenge the conventional notion that CROs are simply vendors providing capacity for a specific project,” said Ken Getz, senior research fellow at Tufts CSDD and author of the study. “Clinical outsourcing offers a development speed advantage at comparable quality. And as the volume and scope of clinical research activity worldwide continues to grow, CROs increasingly are providing a workforce that is essential to the long-term viability of the enterprise.”

This study is the first comprehensive quantitative analysis of the overall impact of outsourcing on drug development performance and capacity. Tufts CSDD estimates that $5.5 billion, or 15%, of global drug development spending, excluding pass-through fees (e.g., central lab costs and investigator grants), went to contract clinical services in 2004. This compares to 12% in 2001.

The Tufts CSDD analysis also found that development spending by sponsors has grown 9% annually since 2001, while clinical development headcount growth has been flat. Also, employment trends suggest that CROs are the primary mechanism utilized by sponsor companies to augment rising global capacity needs and contain R&D costs.