What Are Contract Research Organizations and Why Are They on My TV?
November 1, 1999 3 minutes read
Funding News
What Are Contract Research Organizations and Why Are They on My TV?
You may have noticed their advertisements on the evening news, or heard them on the radio on the way to or from work. They are Contract Research Organizations (CROs) and they have found a way to tap into the money provided by pharmaceutical and medical technology corporations eager to complete clinical trials to move their products to the medical marketplace. What once was the realm of the academic health center is rapidly becoming the domain of small and large businesses that are creating their own specialty niche by running clinical trials. With the rapid proliferation of new medications and surgical and medical devices comes a need for proof of safety and efficacy in the clinical arena. In order for the pharmaceutical and biomedical technology companies to recover their investments in developing these products and begin to generate income, they need to obtain FDA approval by the most rapid and efficient means possible. These corporations are recognizing more and more that academic health centers are likely to take longer to complete this task than their profit-motivated private-sector counterparts. As a result, the CROs have been successfully pulling trials, patients, and dollars away from academic centers.
In his article entitled "Academic Centers, CROs Vie For Industry Dollars" in The Scientist, Paul Smaglik points out that in an environment of diminishing revenues due in large part to HMOs, some academic centers have begun to fight back by forming their own mini-CROs. Smaglik cites Duke University’s initiatives taken with pharmaceutical and device manufacturers which have focused on the relatively specific area of testing cardiac-based products.1 Smaglik goes on to point out that the CROs have responded in kind by developing specialized arms to address specific areas. As an example, the Quintiles Transnational Corp., a $1.2 billion company in 1998, generates revenue by conducting general medical trials, but also conducts trials in specialized areas such as oncology, pediatrics, and women’s health. Corporations such as Quintiles can use their familiarity with marketing strategies to their advantage, as evidenced by their collaboration with former Surgeon General C. Everett Koop, using his Web site to help enroll patients in their trials. Academic centers will, no doubt, need to improve their marketing skills to keep up with corporations who know their way around this environment very well.
Is this just a problem for the clinical academic researcher who wants to perform Phase II or III clinical trials? Not any more. Smaglik also points out that Covance, Inc., is expanding into preclinical trials in areas such as toxicology, which were previously the territory of government-sponsored research at academic institutions.
From the vantage point of academic medicine, the old adage "if you can't beat them, join them" has been transformed into "you better beat them in a proactive manner or join them early before they take away your trials." The medical research environment today requires not only clinical and scientific skills, but also a knowledge of marketing and economics. (By David A. Corral, MD.)
Reference
1. Smaglik P. Academic Center, CROs Vie For Industry Dollars. The Scientist 1999;13:9.
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