CR sites can survive & thrive despite poor economic conditions

Here is some expert advice

The clinical research industry has hit another economic low point as the economy continues to falter and there is little chance of further economic stimulus money for research through a renewal of the American Recovery and Reinvestment Act of 2009 (ARRA).

Academic research institutions are suffering from losing interest income from investments, federal grants are down, and even industry-sponsored trials are harder to come by. All of these factors have made it very challenging for research sites to maintain projects and staffing, experts say.

"Everybody has to deal with this; obtaining federal funding is getting increasingly difficult," says Brian C. Springer, MHA, executive vice president of Roswell Park Cancer Institute in Buffalo, NY. Springer formerly was the executive director of research and business administration at Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, MO.

"It's been harder to get money from many sources we traditionally used to fill in the gaps from extramural funding," Springer says. "These include philanthropy and endowments, which are starting to come back in value, but are still challenged due to stock market declines."

Many different research institutions have had to cut their workforces in the past two years, although things are slightly cheerier than they were in 2008, Springer says.

CR sites find they have harder studies, less studies, and less staff than what they once had, says Wanda Kay North, PhD, MBA, RN, CCRC, CIM, manager of The Center for Clinical Research at St. Joseph's/Candler Health System in Savannah, GA.

"That's a lot of pressure on the manager and staff, as well," North says. "I have to expect more and more from my staff, and sometimes it's difficult to explain to them that they'll have to enroll subjects if they want to keep their jobs."

CR managers have to toe a fine line between pushing for the highest productivity, retaining staff, and maintaining morale, North adds.

Managers also have to convince higher administration that the CR office needs to maintain staff in order to generate the funds that will keep research going.

"If you're not involved in the research world you don't understand the magnitude of the work that goes into research," North says. "It takes trying to educate the higher administration about what exactly it is you do in the office so they won't just see the dollars, but will see the work that goes into getting those dollars."

All of this requires a focus on communication and education.

Clinical research sites now live in a post-ARRA world.

"ARRA helped to add or maintain jobs, but now it's pretty much over," Springer says. "Institutions that were set up based on some level of projected growth in resources, even with a diversified portfolio, have not had adequate funding to sustain their operations at the same level."

Plus, Medicaid payments are down in many states where legislatures are enacting across-the-board cuts to balance budgets, and Medicare reimbursement may face challenges in the long-term.

"Many of the ways we have traditionally funded research have been strained or reduced or both," Springer says. "Many of us look to the National Institutes of Health or the National Cancer Institute, but those budgets have not grown and, in fact, are losing purchasing power."

If there's a federal government shutdown in August, as the congressional impasse over the budget seems to suggest, then even more bad news might be coming.

Given all of this gloom and doom, what can a clinical trial site do to stay economically viable?

CR sites should examine their potential to automate more functions that are currently being done manually, says Judy Capko, founder of Capko & Company of Thousand Oaks, CA. Capko is a healthcare consultant, speaker, and author of "Secrets of the Best-Run Practices."

"After all, staffing is the highest expense for medical practices," Capko says. "Also, automation gives you tools to do more thorough investigation and reporting, as well as refining the quality of services and care you are able to provide."

Here is some additional expert advice on how to weather the economic storm:

• Focus on your CR mission: Even in the best economic times, clinical trials are not a big money generator, Springer points out.

The goal is to conduct clinical research as part of the institution's mission to benefit both patients and science, he says.

"It's something that is mission-based, and it's the right thing to do for our patients and for their care," he says. "One of the things that happens is when you make money on one study, you use it on another study."

Clinical research sites need to keep this mind and make their economic goal one of balancing their more altruistic research work, including investigator-initiated trials with their better funded work for pharmaceutical and biotechnology companies.

"It's very important to us as an institution to have investigator-initiated studies, which utilize unique scientific strengths of our center and bring the benefit of this science to our patient population," Springer says. "But from a financial perspective, we try to run as close to breaking even as we can."

• Cut costs where it's possible: One way to do this is to look at the study staff, clinical trial team, and make sure the team is right-sized, Springer suggests.

"Make sure people are in the appropriate roles, and then you can do things efficiently," he says. "Figure out how to reduce your costs and improve quality."

The key is to right-size staff by making certain every employee is contributing to the site's quality performance, and that is only possible when the best performers are hired.

For instance, in the cancer research realm, sites will have CR staff that are more specialized in both clinical research and regulatory roles. Some work task division is necessary to keep the office running optimally.

"In my view, having a cancer nurse fill out regulatory forms is not a good use of nursing time," Springer says.

"I think you should apply the same business principles of any medical facility," Capko suggests. "Carefully monitor revenue against the cost of doing business and run a lean machine by eliminating waste, duplication, errors, and steps that do not provide an added-value to the patient or staff."

Many large academic research institutions have been cutting costs across the board by withholding pay raises, freezing benefit contributions, and shifting more health care costs to employees.

Clinical trial sites within these organizations will be impacted by these cost-cutting measures. They'll need to pay more attention to the staffing needs they can control, including putting more effort into hiring and retaining people who will be able to work in a high productivity, high quality environment, North says.

"During these economic times you might not be able to use an outside recruiter, whereas at one time we could afford it," she says.

• Right-size the study portfolio: "There are a number of studies and discussions of studies that don't accrue," Springer says. "You don't want to have hundreds of open studies that don't accrue and don't bring value to patients or the agency."

So CR sites should try to reduce their open studies to the ones they really need and will be able to meet enrollment goals.

"There are ways to make these more efficient, including using central IRBs and academic-cooperative groups, which have less of a burden and can be done with more studies and sites," Springer says. "Try to get rid of studies that don't accrue."

It's more difficult to small CR sites to right-size their portfolio, although they still can be cautious when selecting studies.

"My existing clients are putting more effort into examining potential studies to get involved with, and if it is a solo physician there may be challenges with recruitment," Capko notes.

All sites will need to identify creative ways to boost enrollment in slow-performing studies.

"For example, if you have studies and relationships with other centers and affiliates, you might be able to use that to boost the number of patients coming in for studies," Springer says. "Or, you could even share staffing costs."

There are examples of businesses that succeeded at increasing their business capacity when others were cutting back, including Southwest Airlines, which added flights while other airlines cut them, Springer says.

"For a while they were the only airline making money," he adds. "They're an example of taking advantage of a unique opportunity."

Some large cancer research institutions are following this strategy and are expanding despite the current economic issues.

"They're continuing to keep the mission going, extending their brand for what the center might do, accruing patients and getting novel collaborations and strategies, finding new funding mechanisms, foundations, and other support," Springer says.