"It's not too late to reverse the trend of drug companies moving clinical trials from academia to community sites." Vic Lampasona, Director, CPRP

by Vic Lampasona elly Winfrey suffered for years from the debilitating effects of systemic lupus erythematosus, which made even simple activities almost impossible. Sometimes she couldn't get out of bed, much less put shoes on her swollen feet. Then she volunteered to participate in a clinical drug trial at Emory. Today, the 31-year-old woman holds a fulltime job and leads a normal life. Not all patients are so lucky. At Emory and other academic health centers (AHCs), opportunities for participating in clinical trials of new potentially innovative drugs are becoming increasingly scarce. Most clinical trials are now conducted outside teaching centers, a turn that challenges our differentiation in the marketplace, threatens our referral stream, and could impact patients. It's not that new drugs aren't being developed. Pharmaceutical and biotechnology companies currently spend billions of dollars investigating hundreds of promising new medical therapies in clinical trials. During the last quarter of 1998 alone, companies submitted 12 new drugs to the FDA for market approval. Another 48 investigational medicines entered clinical trials to be evaluated in up to 30 studies. Until the early 1990s, AHCs conducted more than 85% of the clinical trials investigating new medications. Over the past eight years, though, AHC market share of corporate-funded clinical trials has eroded to 45%, as drug companies have outsourced testing to for-profit contract research organizations (CROs), which use community hospitals and physician clinics to conduct clinical trials. Such nonacademic sites typically are less bureaucratic than teaching centers and provide data perceived to be good. It's not surprising that academia has lost its advantage on the playing field it once dominated, since grant approval time and patient accrual rates (how quickly patients are enrolled in trials) are especially important criteria in selecting clinical trial sites. To drug companies, time is money. Drug developers lose about $1 million every day a new medicine is delayed from the market. In academia, though, grant approval can take months to filter through departments, deans, Institutional Review Boards, and others who have to sign off. In comparison, the process usually takes only a few weeks in the community setting. Some community sites do clinical trials for a living and might enroll 30 patients or more a month. Some AHC-based sites might enroll only one patient a month. There are still plenty of opportunities for AHCs willing to be more responsive to the corporate clinical trial market. Companies that value the academic stamp of approval are particularly interested in placing studies at AHCs that have re-engineered their clinical trial process. These companies recognize that when clinicians consider whether to use a newly marketed drug, they look to the Emorys, Dukes, and Harvards, where respected experts can talk about their experiences with new drugs. An AHC endorsement confers credibility on a product and can reduce the medicine's time to peak sales, a valuable marker of a company's return on investment. Why should Emory make the changes necessary to embrace corporate clinical trial sponsors? The answer is obvious. Through clinical trials, our physicians gain experience in cutting-edge medicines and technologies that can benefit our patients. Clinical trials, if managed appropriately, can provide free investigational medicines to patients and institutions participating in studies. Partnering with drug developers in discovery and testing of new treatments is among the ways Emory sets itself apart from its competitors. With clinical trials, Emory patients have more access to the potential benefits of new drugs than neighboring community health systems offer. Without clinical trials, Emory physicians may need to refer patients to community researchers outside our system.

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Emory is working toward reclaiming its role as a powerhouse in the clinical trial marketplace. To implement part of the research strategic plan, the Clinical Pharmaceutical Research Program (CPRP) provides administrative and clinical support to Emory investigators participating in clinical trials. CPRP strives to expedite the approval process and match clinical study opportunities with Emory investigators. CPRP nurses are available to coordinate and carry out on-site trials. CPRP is working with Emory Healthcare marketing on a media campaign that will bring research success stories like Kelly's to the community. In addition, Emory has formed research alliances with the University Healthsystem Consortium and Quintiles Transnational, Inc, one of the largest CROs in the nation. Such alliances will bring more quality clinical trial opportunities to Emory faculty. These strategies alone are not enough, however. The entire Emory community must understand that clinical trials are good for Emory and its patients. Academicians, clinicians, and administrators must work together to make the current grant approval and logistical processes more efficient and cost competitive. The accounting system must correctly bill study-related charges to grant accounts the first time. After all, research charges are guaranteed payments, without the usual collection charges that accompany other types of billing. And most of all, patients must be encouraged to volunteer to participate in clinical trials. Patients come to Emory expecting the latest and the best. It is up to all of us to make sure they are not disappointed. For more information about the CPRP, call 404-778-3945.