Author: Eva Pastor
Date: 11-03-09 12:59
Source: The Dallas Morning News
URL: http://www.dallasnews.com/sharedcontent/dws/bus/stories/110309dnbusclinicaltrials.3a8af77.html
Date published: November 2nd 2009
Dallas area sees significant growth in clinical trials
Monday, November 2, 2009
By JASON ROBERSON / The Dallas Morning News
Testing a new drug on patients used to be done at universities, which could count on hundreds of millions of dollars a year to conduct the trials.
But as pharmaceutical companies look to cut costs and get drugs to market quicker, outsourcing to other companies is an increasingly popular option.
The change is gaining importance in North Texas, because the Dallas-Fort Worth area is becoming a hot spot for clinical trials. They used to be limited to university hospitals and biotechnology centers in the Boston area.
"It's been a steady increase over the past 20 years," said Dr. Thomas Stephens, president of Stephens & Associates, a Dallas-based clinical trials company.
There are 877 clinical trials in Dallas looking for participants, according to clinicaltrials.gov, a Web site maintained through the U.S. National Institutes of Health.
But 70 percent of clinical trials are conducted in the private sector with individual companies overseeing drug testing, said Dr. Perrie Adams, associate dean of research administration at UT Southwestern Medical Center.
"It's cheaper, the overhead is not as much and it's quicker," Adams said.
UT Southwestern's overhead includes salaries for faculty and funding for the four institutional review boards, or IRBs, on campus. IRBs are federally regulated groups to ensure human research is ethical.
All clinical trials involving people, including those done in private practice, must obtain IRB approval, but clinical trials in the private sector often are outsourced to whomever the drug company selects.
The university hospital finds research participants by waiting on patients with a particular ailment to check into a hospital, making the clinical trial take longer.
"We can advertise in The Dallas Morning News for acne screening and get enough participants in two to four weeks, but it might take [a university] six months," Stephens said. "For a pharmaceutical company, that's time to market."
In a clinical trial, doctors referred to as investigators give the drug to patients who have been screened for a specific ailment. The test, which occurs in three phases and must meet federal safety guidelines, caps an average 15-year process of a drug advancing from discovery to the medicine cabinet.
R&D
Clinical trials are part of research and development, which drug manufacturers spent $65 billion on last year, says the Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based trade group for the drug industry.
On average, companies spend $1.3 billion on research and development for each drug, an increase of $500 million since 2000, according to the trade group. Half of that spending, $626 million, is invested in clinical testing.
But only 10 percent of the nation's 720,000 physicians tap into the money, according to data from Synergyst Research, a San Antonio-based company that helps doctors land clinical trials for extra income.
Trudy Madan, 34, previously an executive in managed care and for physicians organizations, started Synergyst with colleagues after noticing the shift toward individual physician practices conducting clinical trials.
Madan said the company is expanding into Dallas-Fort Worth, looking for 10 to 15 physician groups that wouldn't mind earning extra money to conduct clinical trials. With physicians finding it increasingly difficult to get reimbursed from insurance companies, Synergyst is hoping its offer sounds appealing.
Ripe for research
"Some of the country's premier physicians and clinics are located in Dallas, and few of them participate in clinical research," Madan said.
So far the 3-year-old company, with $10 million in annual revenue, has contracted with more than 300 physicians and placed more than 400 clinical trials. It operates in Houston, San Antonio, Austin and cities in 13 other states.
On the low end, physicians with Synergyst can earn $50,000 for facilitating a clinical trial with 10 research participants. The high end exceeds $100,000. The company says it has generated more than $20 million in revenue for physicians.
Still, university-led research is perceived as more credible, Adams said. UT Southwestern also has a conflict-of-interest office, requiring annual disclosures from faculty of any relationships with drug companies, including equity stakes and pay for speaking engagements.
Madan, chief executive of Synergyst, said the company's clinical trials also are free of conflicts of interest.
"If a physician has significant stock in the company, then the company will choose not to do business with them," Madan said.
The physicians have no incentive to steer research in any particular direction, she said.
"It's a very regimented procedure," Madan said.
Dr. Barry Brooks, a Dallas oncologist and chairman of the Texas Medical Association's cancer committee, participates in clinical trials in the private sector, but he disagrees with the income potential that Synergyst cites for physicians.
"If you see those numbers, you'd think doctors are making out like bandits," Brooks said.
The work is tedious and often requires physicians to spend their own money to complete the clinical trial, Brooks said. In a clinical trial, physicians answer to the Food and Drug Administration, which can require three times the paperwork of a typical insurer.
"In the end, the money gets vaporized and you often spend more than you get," Brooks said. "I wish there was a way for doctors to recoup the money they've lost in reimbursements, but I don't see this as being one of the possibilities."
Brooks has spearheaded five clinical trials with the Texas Oncology group, which last year lost money on conducting the tests. Texas Oncology's financial gatekeepers have warned their physicians to be more cautious of what clinical trials they accept.
"Making a lot of money has never been possible for us," Brooks said.
|
|
