The Duke Clinical Research Institute, through conducting clinical trials of drugs developed by pharmaceutical companies and carrying out statistical medical research, has become a more integral facet of the Medical Center and has enhanced the University's stature in the medical community.
The majority of the DCRI's resources go towards clinical trials, said Dr. Christopher Granger, assistant professor of medicine and director of the cardiac care unit at the Medical Center. These trials, which randomly assign between 5,000 and 40,000 patients to one of two treatments, allow the DCRI to test the quality and effectiveness of various therapies.
The DCRI is currently directing 10 to 15 trials which are in the startup, analysis, or enrollment phases, Granger said. For example, the DCRI recently completed a trial entitled GUSTO Three, a 15,000 patient trial evaluating heart attack treatments. In addition, the DCRI is analyzing treatments for heart failure and depression following heart attacks, Granger said.
Dr. James Jollis, assistant professor of medicine, is conducting studies in the DCRI's medical research area and has recently published a study comparing the recovery of heart attack victims whose doctors were generalists versus specialists. "Strategies that limit access to specialists save money," but hurt patients, he said.
Hospital-affiliated organizations like the DCRI, however, are not the only institutions performing clinical trials. Since the 1970s, operations known as Clinical Research Organizations have been evolving, providing competition to researchers such as those at the DCRI.
Like the DCRI, CROs develop contracts with pharmaceutical companies to test the effectiveness of the drugs these companies develop, said Bob Taber, director of the Office of Science and Technology at the University.
Both types of organizations then contract the testing of new drugs to specific hospitals, such as the Duke University Medical Center, Taber said. Patients at these hospitals will then use the new drugs, and if the drugs are proven effective, the pharmaceutical company will petition the Food and Drug Administration for approval.
Taber said that the relationship between the CROs and the DCRI is one of both assistance and antagonism. "We work with the CROs.... We compete with the CROs," he said.
Although both a CRO and the DCRI test the drugs developed by pharmaceutical companies, the CRO is not required to publish negative results, Taber said. He said that the DCRI, however, as a subsidiary of the University, does publish all results of clinical trials, regardless of whether the drug is shown to be effective.
Granger said the difference between the two organizations is important. "If the reason we're doing this is to improve patient care, then we want to be able to publish" negative results, he said. In addition, Jollis said publishing results regardless of outcomes gives the DCRI independence.
Connie Mordeth, senior vice president of corporate planning and business integration at Quintiles, a CRO located at the edge of Research Triangle Park, said, however, that CROs themselves do not really play a large role in deciding what data are published. When results are generated by a CRO, she said, the material submitted for publication is decided upon by the pharmaceutical companies and medical centers, Mordeth said.
Another difference between the DCRI and a CRO is that a CRO is a profit-driven organization, while the DCRI is non-profit organization. Taber said, however, that he does not believe this difference in the goals of the two organizations contributes to differences in the quality of research performed.
Mordeth also said that she does not believe a CROs' profit goals hurt the integrity of their research. "We've upheld the quality and integrity of the work that we've done," she said.
Despite the fact that both types of organizations regularly do quality work, Granger said that the DCRI has two main advantages over CROs. First of all, the DCRI offers an established network of investigators to pharmaceutical companies as well as greater stability because of its close relationship with the University community, he said. "They know our primary goal is to learn how to better treat patients, not generate information to make a profit," he said.
Second, Granger said he believes that DCRI studies, because of their affiliation with the University, have more credibility within the medical community than studies performed by CROs.
While Granger said that he believes these two advantages exist, Mordeth said that she believes pharmaceutical companies face an infinite range of considerations when making a decision, she said. Granger said that the DCRI plans to extend into other areas of research aside from its current focus on cardiology.
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