New York BRANY Power
------------------------------------The Scientist
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(April 26, 2004)
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New York BRANY Power
Group wins more clinical studies for local institutions, with benefits beyond the Hudson.
By Edward Winnick
An alliance of clinical institutions in New York City has attracted clinical studies and research dollars to the numerous medical schools and hospitals in the city, according to the group's president. Opportunities are up, and start-up time is down. But the group has also benefited other research facilities around the country and now has more than 100 affiliates in 18 states.
In the late 1990s, officials at the New York Academy of Medicine had noticed that the number of clinical trials taking place in New York City had dropped from a decade earlier. Although there were many reasons for the decline, one of the main ones was that bureaucratic issues at academic institutions had delayed projects from starting and had discouraged sponsors from future collaborations. In response, the academy, along with five New York City–area institutions, formed the Biomedical Research Alliance of New York (BRANY) in 1998.
Since then, BRANY has grown to 138 affiliates and has not charged fees to any of the research institutions that have joined the alliance since its inception. All funding thus far has come from the founders, which include Montefiore Medical Center, Mount Sinai School of Medicine, New York University School of Medicine, North Shore-Long Island Jewish Health System, and Saint Vincent Catholic Medical Centers.
Touting the advantages the alliance has provided, Eileen Hilton, president and chief executive officer of BRANY, said that investigators have been offered many more study opportunities. In addition, she said, “they get expert legal and negotiating advantages from using BRANY because we have attorneys and staff that are familiar with working on contracts and budgets and protecting them and their institutions.”
Hilton also noted that BRANY takes care of a lot of the start-up work, such as regulatory document preparation and Institutional Review Board (IRB) submissions, free of charge for institutions that join the alliance.
In addition to its success in attracting sponsors and partners, the alliance also has kept its costs down, employing a relatively small but specialized staff that has allowed it to be highly efficient in managing the clinical trial process. “Because we're so specialized and so expert at doing certain aspects of this, things move much more quickly here,” Hilton told The Scientist. “What might take 90 days to go through an institutional grants office and IRB in an academic center will take 28 here.”
The growth into other regions came because of capacity, said Hilton. “We were getting so many trials in certain disciplines that we didn't have enough sites to locate them,” she said. “We felt that it was better to be able to offer the sponsors who were coming to us a greater variety of geographical choices, so we moved on to other states.”
Victor Hatcher, director of the Office of Research and Sponsored Programs at Montefiore Medical Center in the Bronx, said he couldn't tell whether belonging to BRANY has cut costs for the center in conducting clinical studies. He noted that because each trial is unique, the center's costs are “too varied” to determine if they have gone down.
However, Hatcher called BRANY a “major success” and noted that since the alliance's formation, Montefiore has experienced a 25% increase in the number trials it is running. While the center and investigators in the study may only get 5 to 10% of the fees a sponsor pays, the money adds up as the number of trials increases.
Although BRANY's network of research institutions has increased significantly since its founding, Hatcher said he doesn't view the other alliance members as competitors. Instead, he points to the large clinical research organizations (CROs), which either conduct the studies themselves or contract out work to academic and other research institutions, as the chief competitors in gaining drug company studies.
Hilton, however, said she views the CROs mainly as partners. “They are our customers,” she said. “We are basically serving them.”
Although the CROs contacted for this article declined to comment, BRANY's partners have included some large players in the CRO field, including Wilmington, NC–based PPD, Inc., and Waltham, Mass.–based Parexel International Corp.
In addition to the CROs, BRANY has conducted studies for major drug firms, including New York City–based Pfizer, Swiss pharmaceutical giant Roche, and St. Paul, Minn.–based 3M Pharmaceuticals. Industry sponsors who use BRANY to conduct studies of their drugs pay the alliance for the IRB reviews and institutional overhead, but Hilton said that there is no additional cost to the sponsors above what they would pay for administrative services if they didn't use the alliance.
“We like to think of ourselves as a very low-cost but very high-quality organization that will end up surviving and excelling on volume,” she said. “The more volume we do, the better we'll do.”
Editor's note: Please see a feature on clinical trials in the current issue of The Scientist.
Clarification (posted 4/30): The 5-10% figure cited in the ninth paragraph of this story refers to how much investigators would generally net after expenses. BRANY does not charge the investigators any fees and shares in overhead costs with the institutions running the studies.
Links for this article
Biomedical Research Alliance of New York
http://www.brany.com/
S. Warner, “The tribulations of clinical trials,” The Scientist, 18:20, April 26, 2004.
http://www.the-scientist.com/yr2004/apr/feature_040426.html