Paediatrician David Nathan believes the AHCs should be at the cutting edge of research, not running big clinical trials.
Traditionally, drug companies both managed and sponsored clinical trials while academic health centres (AHCs) conducted them. But times are changing. Drug companies, under increasing pressure to find ways to cut costs, create efficiencies and reduce time-to-market, are increasingly opting to outsource the management of clinical trials to commercial entities. Many of the trials are now taking place in venues other than the AHCs, such as community hospitals, which are competing hard for a share of the clinical-trials market in much the same way they already do for patient care.
New for-profit players have entered the marketplace over the past two decades and include contract research organizations (CROs) and site-management organizations. There are even companies that match drug companies with CROs in an effort to streamline the outsourcing process. Although outsourcing of clinical trials is creating new jobs, a job in a CRO will not suit everybody and not everybody will thrive in such an environment. "It is a changing environment and so it's important to be able to cope with change and also be very solutions-driven," says Helen Wyn Davies, senior vice-president of clinical development services at Quintiles, the largest drug CRO in the United States. Moreover, as this is a service industry, "you're viewing life very much in terms of a provision of a service," she says.
The CRO industry draws a high proportion of its employees (about 80%, according to Joseph von Rickenbach, chairman and chief executive of Parexel, one of the top three drug CROs in the United States) from the pharmaceutical industry. There, it is not uncommon for individuals to focus on one therapeutic area and be assigned to a particular study for years at a time. One of the benefits — and challenges — of working within a CRO is that the companies offer the chance to work on several different therapeutic areas and studies, and with a range of clients, within a short space of time.
It was just such an opportunity that attracted Gary Gartenberg to Covance two-and-a-half years ago. He had been in private medical practice for 20 years before deciding on a career move. "It's been very motivational to be involved in a company that cuts across the entire industry," says Gartenberg, one of 15 physicians in the clinical-development team that designs and reviews the protocols and deals with the trial's medical aspects and safety monitoring.
Although working with CROs provides variety, the job has disadvantages as well. For example, publication opportunities are fairly limited. "It doesn't happen as often as I would like," says Raul Valentin, vice-president of human resources for Covance's Clinical Development Group. As all CROs operate under strict confidentiality agreements and non-disclosure policies, clients must consent to publication of any information deemed proprietary.
REGAINING LOST GROUND
While some CROs continue to expand their global reach, and are moving into areas such as discovery, product development, manufacturing and sales, AHCs are rethinking their provision of clinical services. In an effort to create a more industry-friendly environment, some AHCs have formed centralized clinical-trial units to address the issues concerning patient recruitment times, delays in institutional review-board approval, quality assurance and higher costs that are causing drug companies to go elsewhere.
Some institutions have established formal relationships with CROs in the hope of expanding their access to industry-sponsored trials. Parexel's oldest and most successful alliance is with Humboldt University. "It's so intimate that our company has several hundred employees on campus in Berlin," says von Rickenbach, and physicians at the university can intern with Parexel. von Rickenbach admits, though, that forging such partnerships can be arduous work. "We are a commercial company... and academic centres are not. Their primary purpose is not to earn a return to shareholders and to get these two purposes... onto a common denominator is not easy," he says.
Indeed, not all such partnerships prove fruitful. Three years ago, Johns Hopkins Medical Institutions entered into a non-exclusive agreement with Quintiles. Johns Hopkins hoped that Quintiles would steer more clinical studies its way and in return Quintiles would have the name recognition of Hopkins and access to its top clinical investigators. "In reality [Quintiles] didn't give us anything and they weren't very interested I think in developing a real lasting relationship," says endocrinologist Adrian Dobs, at Johns Hopkins. The partnership has since fizzled out.
CROs generally feel that AHCs are basically too slow for them, says Dobs. "We appreciate that and we are trying our best to do better but we're under different constraints," she says. Johns Hopkins established a clinical-trials unit about two years ago. The unit helps sponsors identify investigators but also offers investigators a way to improve how they market their expertise. But as the line between publicly funded and privately sponsored research blurs, issues of academic freedom and conflict of interest need to be worked out more carefully, says David Nathan, president emeritus of the Dana-Farber Cancer Institute in Boston and a paediatrician at Harvard Medical School.
"If universities get involved with it for the money, I worry about that too because it's not really the academic mission," he says. "The science is moving like mad. It's extremely exciting and I think that's where the AHCs should be, not running big clinical trials."