Today's CR challenges bring past trends to critical juncture
Today's CR challenges bring past trends to critical juncture
Tighter budgets, more oversight among issues
Clinical research in the 21st century is no less important than it was in the last century, but changes in how studies are conducted and regulated have made the business much more difficult, an expert says.
"I think there are a number of challenges now, and it's to the point where it's unclear to me if the reward exceeds the challenges," says Colleen M. Schmitt, MD, MHS, FACG, FASGE, chief of the gastroenterology section of Galen Medical Group in Chattanooga, TN.
Schmitt has published a paper about how tighter budgets, increasing competition and litigation costs, more oversight, and financial headaches have led to a challenging environment for clinical trial sites.1
"I don't mean to be a pessimist, but the reality is that clinical research has changed in the last 15 years," Schmitt says.
For one thing there are more litigation risks with a growing entrepreneurial niche for trial lawyers, she says.
"What that translates into for sites is there are many more risks that are unknown," Schmitt says. "It's like Whack-a-Mole, you fix one problem and another problem comes up that you didn't know was a problem."
The second major change in the past 15 years is an increase in regulatory burden for clinical trial sites, Schmitt says.
"That was sparked on the national level by disasters that occurred at academic sites," Schmitt explains.
The instances of bad publicity for clinical research have led to a public view that some private medical research sites are mercenary and coerce patients to participate in clinical trials for the sake of generating profits, Schmitt says.
"Nothing could be further from the truth," she says. "Sites operate on increasingly tight budgets."
The budgets are constructed with a fee schedule that's based on the protocol's physical requirements, she adds.
While there's a push among the National Institutes of Health and FDA to increase diversity in clinical trials, there also are greater enrollment pressures and competition among trials.
"And they want you to increase enrollment among populations that have traditionally been fearful of the clinical trial process because of disasters like the Tuskegee syphilis study," Schmitt says.
"There are big pressures related to the way protocols are implemented," she adds.
"A site that has been trained carefully in good clinical practices and is meticulous in informed consent and enrollment criteria can operate in this field successfully," Schmitt says. "But the less well-trained sites may not be as savvy about how careful they need to be when working in this kind of environment."
Today's protocols require more procedures and more face-to-face time with participants, and sponsors have taken the attitude that this is the site's cost of doing business and it's non-negotiable, Schmitt says.
Given these current financial pressures, it would be naïve for any new investigators to believe that research is a cash cow, she adds.
"It was possible in the early 1990s as the shift moved trials from academic medical centers, which were very expensive, to sites in the community that they could operate on a profit," Schmitt says. "But that was then and this is now."
Clinical trial sites will survive in today's environment only by understanding the costs of doing business and by being cautious about hidden costs.
"Most of the uncompensated costs are uncompensated salary for hours devoted to study start-up, screening patients, attending meetings, and screen failures," Schmitt says.
The single most important investment investigators can make when starting clinical research is to hire a qualified clinical trial coordinator, Schmitt suggests.
"The FDA doesn't require certain education or training," she adds. "What's key is that the individual you hire is highly self-motivated and an independent worker."
The ideal clinical trial coordinator will be someone who doesn't require continuous oversight and coaching, but is a person of unquestionable integrity and is very detail-oriented, Schmitt says.
Investigators might find such individuals among nurses or phlebotomists, she adds.
When physicians first begin to conduct clinical trial research they could create a good research site by making certain their research staffs are well trained and highly motivated.
"But it all hinges on the training, and they must have adequate time to perform the task required," Schmitt says. "Clinical research is not an area that can be rushed."
For many nurses, clinical research affords them time with patients that they haven't had in years.
"They can spend as much time as they need with each patient to discuss the procedure and provide informed consent," Schmitt says. "It's an ongoing and time-consuming process, and if they feel rushed or distracted by other clinical responsibilities then it's a recipe for failure."
So with the increasing number of challenges to conducting clinical trial research, why do physician investigators continue to work in the industry?
"That's a question I review continuously, but I've thought about it more in the last few years," Schmitt says. "You have to weigh financial and legal risks against benefits."
For example, in Schmitt's role as a gastroenterologist, one of her key benefits is having access to key therapeutic agents that may not be available to physicians who are not researchers.
Since many Crohn's disease patients have failed existing treatments, it would be difficult for physicians to treat them without having access to clinical trials, Schmitt says.
Another reason to conduct clinical trials is an altruistic one: "There is so much that is unknown and could potentially benefit others," she says.
Building trust and esteem among patients are also good reasons to do research. "Patients enjoy seeing a physician who is on the cutting edge of health care," Schmitt says. "Communities take pride in having an academic research health care center, and most physicians doing it are interested in advancing health care."
Reference
- Schmitt CM. Research in clinical practice. Gastrointest Endosc Clin North Am 2006;16:751-773.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.