Johns Hopkins Medicine announced yesterday a cooperative agreement with a company that conducts clinical trials of new drugs, part of an effort by Hopkins -- and academic medical centers in general -- to attract more such work.
Through this arrangement and other efforts, Hopkins hopes to double its trials research, currently worth about $25 million a year in revenue, said Dr. Adrian Dobs, director of the recently expanded clinical trials unit at Hopkins.
The deal is with Quintiles Transnational Corp., based in Research Triangle Park, N.C. Quintiles is the largest of the companies that serve, in effect, as research brokers. Pharmaceutical companies hire them to test new drugs, and they in turn line up medical researchers to do the work.
Hopkins and Quintiles will work together to identify research opportunities, and Quintiles can offer companies Hopkins researchers as it bids for clinical trials work. There is no retainer or payment other than for work done, but both sides hope to attract more trials because of the partnership.
Quintiles has announced similar arrangements with two other academic medical centers, Cleveland Clinic and Emory University, in the past few months. Other research companies have not made such arrangements, according to Dr. Bert Spilker, senior vice president for scientific and regulatory affairs at Pharmaceutical Research and Manufacturers of America.
Besides providing revenue and research opportunities, clinical trials can help Hopkins attract patients. "Patients are interested in the latest available treatment options," Dobs said. "The patients are getting more sophisticated -- they're surfing the Internet," then asking if Hopkins can provide some of the newest drugs.
Robert Whittaker, editor for CenterWatch, a publisher of newsletters about clinical trials, said academic medical centers see clinical trials as "a marketing thing," something needed "if you want to maintain that reputation for cutting-edge research. Some say this is more important than the direct revenue" from clinical trials.
Consequently, he said, "there are 20 or 25 [medical schools] you can identify that have made a strategic decision, usually at the dean's level, to commit resources to attracting more sponsored clinical trials."
Dr. David Korn, senior vice president for biomedical and health sciences research at the Association of American Medical Colleges, said a lot of schools, in an attempt to become more competitive for clinical trials, are establishing a centralized office for negotiating and deal-making.
That's what Hopkins has done. Dr. Bart Chernow, vice dean for research, has beefed up the clinical trials unit. Formed five years ago just for the epidemiology department, the unit has, for the past few months, been serving the entire medical school.
Smoothing the process has become important because drug companies were balking at the time and cost of some clinical trials -- as much as 10 to 12 years and $500 million, said James Hamill, vice president for accelerated clinical research at Quintiles.
While Hopkins was expanding the clinical-trials unit, Quintiles was setting up the accelerated research group, designed to show potential clients that Quintiles can offer "good investigators, well organized and able to start quickly," rather than going through lengthy approval processes.
The stakes are considerable. Spilker's trade group reports that its members, covering the large U.S. drug companies, spend $21 billion a year on research, of which 35.8 percent goes for clinical trials. The academic medical centers, such as Hopkins, and the contract research organizations (CROs), such as Quintile, have reason to be worried about market share.
There has been a tendency for some clinical trials work to move away from academic medical centers to community physicians. Korn said the other institutions promised to do the work "faster and cheaper."
And, he said, the medical schools were disdainful of some clinical trials work because it was "standardized" and lacking in "intellectual excitement."
For the CROs, Whittaker said, the competition comes from large pharmaceutical companies managing the clinical trials internally rather than contracting the work to CROs.
The drugs companies, he said, have been somewhat "unhappy with the quality of services" they get from CROs. "In the past five or six years, the percentage being out-sourced has been going up, but some sense there's a flattening out."
Offering streamlined arrangements with prestigious medical schools is a strategy for regaining the momentum, he said.
Hamill said it is too early to assess the results from Quintile's deals with Emory and Cleveland Clinic, although "we're very pleased with the activity levels."
Spilker said the deal offers "glitz for Quintile" but might not provide a great competitive edge. Because the arrangement is not exclusive, he said, "if I'm in another CRO, I'd say [to the drug companies], 'We can go to Hopkins, we can go to Cleveland Clinic, if that's where you want to be. And we'll get the top guy in your disease.' "
Pub Date: 7/28/98