Phase I Complexity a Hot Topic at DIA 2008
Attempting to gain early efficacy data and examining possible biomarkers in intent-to-treat patients in phase I trials has become more commonplace as sponsors attempt to fill their thinning pipelines. And the use of advanced medical imaging and other diagnostics—especially in cardiovascular and central nervous system studies—has pushed the envelope of what traditional phase I units have handled. In many ways, complexity and an increased need for specialized expertise in early phase research is forcing many smaller phase I organizations to improve their infrastructure and focus on particular disease areas.
Princeton, N.J.-based Covance’s global vice president of clinical pharmacology, Mary Westrick, Ph.D., runs the contract research organization’s (CRO) early phase research and talked to CenterWatch, during DIA's 44th Annual Meeting in Boston this week, about some changes she’s seen over the years. Covance is a leader in the phase I indsutry.
“We’re seeing that our clients are going to [intent-to-treat] patients as early as they can. The industry has really been trying to find out as much about a compound in one study as possible, but that also makes those trials more challenging to do. You have to have more medical expertise; you certainly have to have the emergency facilities around to be able to do it,” said Westrick.
Westrick stated that in previous years protocols called for separate trials looking for first-in-man data, food affects, age, gender and other criteria. Now these have become multiple arms of the same study. And sponsors want to get early data in treatment populations as well.
“Sometimes it is a healthy volunteer study, with an [intent-to-treat] patient arm added into that. And other times sponsors will do a single dose in healthy volunteers and then go to multiple doses in patients,” she said.
Covance just completed a two-year investment plan by replacing a facility in Evansville, Indiana, that was more than two decades old. The original Evansville facility opened its doors in 1987. In 2005, Covance acquired it through the acquisition of GFI Clinical Services, a division of West Pharmaceutical, for a reported $5.7 million. The purchase included the 80-bed phase I site—a former nursing school dorm built in the 1960s. At the time of purchase, the unit employed a staff of about 100.
“It had done really well. But it had been back-engineered, and back-engineered some more, to make it as custom as possible for phase I research. And there is only so much you can do when you have an existing building. We wanted to build someplace worthy of our volunteers and of the business,” said Westrick.
The new $12.4 million facility has 50,000 square feet of research space, an in-house lab, multiple lounges and larger patient rooms. The facility did not increase the number of beds for the unit, but it has space to expand its original bed capacity. The facility sits on Deaconess Hospital property but is fully owned by Covance.
Other sites that were improved during the company’s program were in Austin, Texas; Daytona Beach, Florida; and Honolulu, Hawaii. Covance has 10 CPUs in the U.S. and UK.
“Bed days are going up. I started out at Covance in our Madison clinic 10 years ago, and at that time the average length of [volunteer] stay was four to five days. Now it is more like eight to 10, because of the additional procedures and information clients ask us for,” she said.
Westrick was quick to add that ensuring patient safety is another reason for the longer duration of stay and that the industry is “appropriately conservative” in making sure that no one is released from care until they should be.