By Adria Cimino
The good news is that biotech companies’ technologies are producing a record number of drug candidates.
The challenge might be getting them tested.
According to CenterWatch, a Boston-based division of Thomson Healthcare, the growth of principal clinical investigators is not increasing enough to meet drug companies’ demand.
Last year, 33,000 principal investigators and 13,000 sub-investigators conducted about 60,000 U.S. clinical trials, the report said.
Sponsors will need 56,000 principal investigators to conduct 80,000 to 90,000 trials by 2005.
CenterWatch estimates that fewer than 48,000 such researchers will be available.
A decrease in investigators could be yet another roadblock along the path to market.
But Vertex Pharmaceuticals Inc. of Cambridge is not worried. The company has an HIV protease inhibitor on the market and about a dozen products in its pipeline. Drug candidates include treatments for HIV, cancer and inflammation.
“We haven’t seen a major issue in that regard,” said Dr. John Alam, senior vice president of drug evaluation and approval.
Alam noted, however, that his former medical colleagues, who initially were interested in research careers, today are seeking industry jobs. The reasons include pressures on the researcher to gain external funding and the difficulties of setting up a laboratory for the research.
In spite of the exodus of some, Alam is certain that the supply of investigators will end up meeting demand.
“The volume of activity on the clinical trial side, you can view as either a threat or an opportunity,” he said. “The volume of products moving through has created more investigators.”
Today, there is an infrastructure for Alzheimer’s disease trials and multiple sclerosis trials that did not exist 15 years ago, making it easier to do these studies now, he said.
The outlook is much the same at Sepracor Inc. of Marlborough.
Lou Vaickus, vice president of medical operations, said the company has a rolling list of investigators who handle its trials.
One challenge, which always has been in existence, is patient enrollment, Vaickus said.
In oncology, for example, 10 percent of patients enter clinical trials. The other 90 percent are treated with the standard medications.
“The patients are out there, the doctors are willing,” said Vaickus, who foresees private practice doctors and university researchers becoming increasingly aligned with the pharmaceutical industry.
Harvard University has taken a particular interest in clinical studies, forming the Harvard Clinical Research Institute in Boston last July.
The institute and the Center for Clinical Research Practice recently announced their collaboration on a program to train clinical investigators.
Dr. Steven C. Schachter, the institute’s vice president of education and training, said that in addition to the speed of innovation outpacing the increase in investigators, public opinion is playing an important role.
News of a few researchers’ ethical dilemmas has affected the entire field.
“To help restore public confidence and at the same time raise the bar of ethical and responsible research is the responsibility of academic clinical research,” Schachter said.
Harvard also launched the “Scholars in Clinical Science” program last year and has enrolled 12 students. A National Institutes of Health (NIH) grant is funding the program.
To make a difference, however, the strategy of educating clinical investigators and the public must be taken on nationwide, Schachter said.
Dr. David G. Nathan, president emeritus at the Dana Farber Cancer Institute in Boston and pediatrics professor at Harvard Medical School, has spent the past several years studying the problem on a national level.
As part of his work with the NIH Director’s Panel on Clinical Research, Nathan has helped outline the problems and suggest remedies.
“They are not growing at the rate we would like,” he said. “There has been a sense of discouragement on the part of these people.”
The reasons are many, Nathan said.
Physicians performing human clinical research felt they were falling behind scientists doing fundamental biomedical research in the NIH grant competition.
Managed care, while “forcing the fat” out of academic hospital reimbursement and the hospitals’ clinical departments, actually eliminated funds that otherwise would support investigators’ programs.
Finally, most research centers are in cities with higher costs of living, putting economic pressure on the young, heavily indebted doctor.
The panel’s recommendations include a new series of NIH grant programs for clinical researchers, and a change in the culture of academic health centers to emphasize the importance of each investigator.
“We feel that there needs to be better collaboration in clinical research,” Nathan said. “Most clinical trials cannot be done by an individual anymore.”
Perhaps the biggest threat to clinical investigators is a loss of public support, and that would result from unethical behavior, Nathan said.
He noted the example of an investigator doing research for a biotech company and owning stock in the business.
“That has to stop
because the media is going to kill us on this,” Nathan said.
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