Expert offers strategies for survival in today's CR environment

Formal SOPs, training necessary

Clinical trial investigators and professionals who hope to survive the regulatory and other burdens inherent in today's clinical research (CR) industry might take some tips from successful sites.

For instance, it's important to make certain all staff receive a thorough on-site orientation and training, says Colleen M. Schmitt, MD, MHS, FACG, FASGE, a long-time investigator and the chief of the gastroenterology section of Galen Medical Group in Chattanooga, TN.

Budget negotiation, the finances of clinical research, and compliance issues also are challenges for CR staff and sites.

Schmitt offers these suggestions on how to handle the challenges and improve your site's performance:

1. Invest in a comprehensive staff training program. "Our orientation and instruction process lasts two weeks and it's formalized and written," Schmitt says. "We have standard operating procedures [SOPs] that are updated regularly, and they're required to become very familiar with those."

Research staff must review and thoroughly understand the SOPs, and they must take an on-line training course through the National Institutes of Health, she adds.

"Also, we require attendance at a good clinical practice conference that we started in Chattanooga six years ago," Schmitt says. "It's a two-day conference for investigators and clinical research coordinators."

The conference reviews these elements: contracts, budget negotiation, litigation risks, national updates, changes in rules and regulations at the FDA, and clinical trial reviews, she says.

"Also, we participate in a forum in Chattanooga that was started by our wonderful compliance officer," Schmitt says. "It's for clinical research coordinators, and it's a monthly brown bag lunch that they review and openly discuss."

Among the topics discussed are inclusion/exclusion criteria and protocol violations.

"Even in small areas like Chattanooga, which is not a big city like Los Angeles or Chicago where there are hundreds of research coordinators and millions of subjects, you can develop good resources and training for people," Schmitt says. "You have to be determined to do it."

2. Treat every budget as negotiable. "If I thought a budget was non-negotiable, the discussion is over," Schmitt says. "Nothing should be non-negotiable because sites are not cookie cutters, and everything varies."

The first step is to do a very careful review of the protocol, she says.

This means looking at more than the timeline and trial procedures.

"Review how much time each activity will require, and look for the hidden costs," Schmitt advises.

"We use a simple spreadsheet, and we know how much it costs to do an EKG exam and a physical exam or a screening visit and informed consent," Schmitt says.

If the costs exceed what the sponsor proposes in the budget, then it's time to show the sponsor your data and negotiate a more sensible budget. Or sometimes the solution might be to change the protocol to reduce enrollment costs.

"Sponsors respond better to data than emotion," she says. "You need to say, 'If you keep this exclusion in the protocol then in our experience your screen failure ratio is going to be 5:1 instead of 4:1, and here's why I'm telling you this.'"

When given data, sponsors are much more likely to respond and make changes, she adds.

"There occasionally are reasons to participate in a protocol when you know you're going to lose money," Schmitt says. "And we'll do that if there's a particular therapeutic area we want to break into, or if there's a novel therapeutic that we think has potential."

Or there might be an opportunity for several studies from that sponsor or there might be a principal investigator who has access to a large number of poor patients who need an opportunity for therapy and have no other choices, Schmitt says.

"There are many sites that are quite altruistic," she says.

3. Know what you're signing in the contract. "One of the big concerns I have, and I see it all the time although it still surprises me, is how novice investigators sign the contract without reading it or understanding it," Schmitt says.

One area of the contract that is accepted without challenge is the cross indemnification, Schmitt says.

"My personal opinion is that physicians have no business indemnifying big pharma," she says. "It's the transfer of risk regarding informed consent to the investigator."

But PIs have no long-term gain invested in the product, and the pharmaceutical company has everything to gain, Schmitt notes.

"Pharmaceutical companies should be indemnifying the investigator because otherwise the investigator is standing alone there," she adds.

Yet, sponsors expect PIs to sign contracts with the indemnification clause, and Schmitt refuses to sign it.

"I really urge sites to review their policy on that subject," Schmitt says. "The majority of time the pharmaceutical company will send us an indemnification letter, and they will indemnify us as they should do."

4. Be wary of disadvantageous fee schedules. "For reasons that escape me except that it's tradition, this is the only business where the payers don't pay their bills on time," Schmitt says. "On average, there is a half-year delay in payment."

This means that clinical trial sites essentially are floating a loan to pharmaceutical companies, she says.

"When you have a discussion with them about this, the rare company will say they'll agree to monthly payments," Schmitt says. "Most of them have never had to do this before, and no one has ever held their feet to the fire."

Nonetheless, this is a practice that should stop, Schmitt says.

"Even more ridiculous is the concept of block payments or payments that are tied to performance at other sites," she adds. "Those are terrible — but a novice investigator would not recognize the language in the contract."

While individual investigators can improve their own sites' financial and overall performance by focusing on these areas, it ultimately will be up to the CR industry to make changes that will encourage rather than discourage new investigators and sites, Schmitt notes.

"It'll never change unless we do it," she says. "This is not an easy field to break into, and I would encourage people who are interested in this business to attend national meetings where they can gain a lot of insight from their colleagues."