Clinical trials company runs an efficient site relying on best practices
Clinical trials company runs an efficient site relying on best practices
Investigator turnover rate is less than 10 percent
While nationally the investigator turnover rate is estimated to be at 50 percent, a clinical research business in Colorado has had great success in retaining more than 90 percent of new and experienced investigators.
Western States Clinical Research Inc. of Wheat Ridge, CO, was founded in the early 1990s by three clinical trial coordinators who felt their skills might be better utilized on a contract basis with a variety of physician investigators, instead of working for individual physician practices.
"We started with one or two studies and now have 15 to 18 studies at a time," says Dara B. Stillman, BA, CCRC, co-director of Western States Clinical Research and regulatory documents coordinator for Western States.
"We limit the number of studies to maintain good quality control," Stillman says. "We made the decision that we didn't want to grow and become a major research company because we both like our free time and didn't want to become workaholics."
One of the keys to the company's success is that Stillman and co-director Cheri A. Casey, CCRC, recognize the importance of motivating principal investigators (PIs). Casey and Stillman were two of the original co-founders of Western States, which will celebrate its 15th anniversary in December. They also spoke about site management at the 15th Annual Society of Clinical Research Associates (SoCRA) Conference: Clinical Research: Changing the Future. . .Touching Lives, which was held Sept. 22-24, 2006, in Chicago.
"It's very important to have an investigator who is motivated and responsive and always available to us by phone, fax, email, and in person," Casey says.
"Principal investigators have to understand their duties," Casey adds. "They are involved in selecting the protocol and signing necessary documents, as well as being available for site visits and investigator meetings."
Investigators also need to be involved in signing off on all procedures, lab work, physical exams, and to meet with monitors and auditors when necessary, Casey says.
"Anything that comes over our desk, we make sure the PI looks at it and signs it," she says.
To improve patient recruitment, Casey and Stillman will meet with each sub-investigator who is working on a study and take them out to lunch.
"We tell them about the study and where we are in enrollment and keep them up to date," Stillman says.
This keeps all investigators engaged and motivated, even if the study is not a top priority for their clinical practice and work, she suggests.
"The principal investigator knows all about the study and has been to study meetings, has conveyed information to other investigators," Stillman says. "But we reinforce this by having lunch with the sub-investigators and going over the study," Stillman says.
"We want to make sure the sub-investigators have buy-in for the study and are on board with our efforts," Stillman says. "And we want to make sure they will call us when they have a potential study subject to refer."
Here are some other suggestions for improving site management efficiency:
1. Develop your own standard operating procedures (SOPs).
"Cheri and I have been doing research for 17 or 18 years, and we didn't have SOPs when we founded Western States, so we based our SOPs on what we already were doing," Stillman says.
"As we change things, or when new information comes up that shows we need to do things differently, we make an amendment to our SOPs," Stillman says. "We make a new version every three years."
The SOPs are made available to all study coordinators, PIs, and sub-investigators.
"We ask them to read through the SOPs and sign off that they have looked at them," Stillman adds.
2. Create a quality assurance system.
"We have systems set up so that once a visit is completed with a subject and the case report form (CRF) has been done, we can pass that CRF to a back-up coordinator who will go through the CRF visit to make sure we've completed everything thoroughly," says Amber Bretz, CCRC, a study coordinator for Western States.
The back-up coordinator determines whether the CRF makes sense and that the study documentation is complete, Bretz notes.
The company uses its own study visit worksheets, incorporating parts of the sponsor's study visit worksheets, if supplied, Bretz says.
"We make up our own worksheet with every study, putting in all of the data points required and all exclusion/inclusion criteria, as well as the case report form," she adds.
There is a template for the worksheets, but they're mostly created from scratch with each study, Stillman says.
"They're based on the way the protocol needs to be carried out, so each is a little different," Stillman says.
The worksheets are kept simple so any of the coordinators could pick one up and know how to conduct the visit, Stillman says.
For quality assurance, coordinators also make certain that when a study drug is pulled off the shelf, the back-up coordinator or study coordinator will check to make sure the appropriate drug was pulled and that it will go to the right study and right patient, Bretz says.
"We also maintain good habits, completing case report forms within 48 hours of a visit, ensuring drug accountability at each visit, and monitoring patient compliance," Bretz explains. "We check to see if patients are taking the drugs as appropriate, and we make sure we have a paper trail so that someone would be able to pick up case report form or other study documents at any time and know what is going on."
At regular staff meetings, coordinators review study enrollment and discuss issues that need to be resolved, she adds.
3. Select appropriate protocols.
The first thing the co-directors look for is whether the clinical research business will be able to enroll the appropriate subjects for a prospective protocol, Stillman says.
"We make sure we have sufficient patient population based on our physicians' practice, previous studies, and through advertising in the community at large," she says. "We also look at how feasible it would be to carry out that protocol, and what our sites' capabilities are to make certain they match the protocol."
The CR company has remained open to expanding and trying new areas of study, however.
"When we started out, we had been working in respiratory clinical research, and we found that we could go multi-specialty," Stillman says.
"Someone came to us with a gastrointestinal study and said, 'All you need to do is find a good doctor to work with you because you do good study coordinating work, and the doctor will know the details about the new specialty,'" Stillman recalls. "So we did this, and we've been able to expand the types of studies we do."
Through experience, the coordinators have learned to avoid certain studies because of enrollment problems, Stillman notes.
"We used to do antibiotic studies and infection studies, but we really don't do those anymore because you have to be located in a doctor's office and look over their shoulder to see who comes in and might qualify," Stillman adds.
4. Brainstorm to solve problems, improve processes.
At monthly staff meetings, the coordinators and co-directors discuss any changes that are being made and how to make the business run more efficiently, Casey says.
"We sit down and brainstorm better ways of doing things, and that seems to work for us," Casey notes.
For example, the study monitors questioned coordinators about why patients didn't sign a revised consent form at a mid-study visit, Casey recalls.
The problem was that once a revised consent form was approved by the IRB, it often would not arrive in the CR office for a couple of weeks, Casey says.
"We didn't have the consent form before the patient's next visit, and we didn't have proof of that, so we brainstormed on how we could fix this problem so it makes sense," Casey says. "We wanted to make sure monitors understood that we didn't have the revised consent form in time to have the study volunteer sign it at their next visit."
They decided to create a log-in book that registers the date of when each consent form was approved by the IRB. Also, they stamp the consent forms with the date that they were received, Casey says.
Another idea that staff will discuss involves trying new methods of recruiting participants, Stillman says.
"I've been looking at Google ads and thinking about different ways we could advertise on the Internet," Stillman explains. "We've always done a lot of newspaper advertising, and sometimes we find we don't get as much bang for our buck as we used to."
The advantage to Internet advertising is that increasing numbers of people are getting their news over the Internet since they use their computer at work and at home, she adds.
5. Perform pre-study visits to assist in subject screening.
The pre-study or pre-screening visit is an initial visit made for information purposes only, Stillman says.
"A prospective study patient comes into our office and we present the informed consent to him or her and discuss the study," Stillman says. "We've already done a telephone screening but, if it sounds like a person will qualify, we bring him in for a pre-screening, pre-study visit."
At this visit, potential participants look over the consent form, then sign it and fill out an authorization for the release of medical records, she says.
The actual screening visit at the PI's office will be scheduled for a week or two later, she says.
This pre-screening visit isn't covered in the study budget, but it's a little extra service we do, and it saves time and trouble in the long run, especially for physicians, Stillman says.
PIs will spend time on a screening visit, and then if the prospective participant says he doesn't want to do the study, or if he is disqualified, then the physician would lose that appointment for the day, Stillman explains.
"So this pre-screening visit helps everyone," Stillman says. "It helps physicians and study sponsors because we're not committing them to pay for the visit and, if we ask for the subject's medical records and find something that disqualifies the person, then it saves the PI time."
It also allows the potential study volunteer to have adequate time to review information about the study, Stillman adds.
While nationally the investigator turnover rate is estimated to be at 50 percent, a clinical research business in Colorado has had great success in retaining more than 90 percent of new and experienced investigators.Subscribe Now for Access
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