New study: Feasibility should be top priority
Get feedback from all departments
Assessing a protocol's feasibility should be a top priority for clinical trial sites. And it's a good strategy to have a thorough feasibility process in place.
"When we are approached or thinking about doing a project here, it is imperative that we understand all facets of it so we can make an intelligent decision of whether we want to do the study here," says Denise Dorman, RN, CCRP, clinical research director for Coastal Orthopedics & Pain Management in Bradenton, FL. Dorman was scheduled to speak about protocol feasibility at the 2010 MAGI Conference - East, held May 23-26, in Boston, MA.
Coastal Orthopedics & Pain Management has 17 physicians, including 11 orthopedic surgeons, five offices, two surgery centers, and five physical therapy departments. The private practice has been in clinical practice for 45 years. The organization has been involved in research for five years, Dorman says.
"It's important that I get the feedback from all of the different departments," she notes.
"We do a combination of drug and device studies, and we have a large amount of physician-initiated research," she says. "So there are a lot of determining factors to whether we're going to do a project."
The bottom line is finding a balance between the financial aspect of research trials and strategic self-interest.
Here are some ways a clinical trial site can ensure a feasibility process that will result in the best decisions about protocols:
Have investigators fill out research protocol sheet: "If the study is a physician-initiated project, then I have a proposal sheet where they write down what they want to do, and I look for funding," Dorman explains.
"They answer basic questions about the study and treatment and patients," Dorman says.
The research protocol form is a simple chart with two columns. The second column is for answers, and the first asks for answers to a variety of items, including these:
- Name or short description;
- Type/study design;
- Initiating investigator;
- Project coordination;
- Device(s) to be utilized (if applicable)/indication;
- Background/history (what's in the literature);
- Patient population and sample size;
- Study population;
- Evaluation criteria;
- Follow-up assessments;
- Data collection;
- Core labs/vendors;
- Statistical analysis, etc.
If a study is sponsor-driven, then Dorman sends the investigator a protocol feasibility form to review and complete.
Have all departments assess study feasibility: "We want to know how much personnel it will take to do the trial, whether we'll need to work with other departments," Dorman says.
If a study, whether it's investigator-initiated or sent by a sponsor, will involve other departments in the organization, then each department will need to complete a protocol feasibility form.
"It's a one-page form that asks if their department can do this for us," Dorman explains. "Once I get all of those back, I look at them, and I have a grid I fill out."
The protocol feasibility checklist form has a table at the bottom for various clinical research groups to complete as "approve" or "reject."
It also has five sections to be completed, with these questions:
- Previous experience with sponsor and/or CRO (Good or Bad)?
- Enrollment goal realistic?
- Enrollment period realistic?
- Have we had similar trial and met enrollment?
- Inclusion/exclusion realistic, screen failure rate?
- Is it well designed?
- Are other departments involved; which ones?
- Extra equipment?
- Extra training?
- Long duration drop-out rate?
- Case report forms complex; what medium?
- Drug/device accountability complicated?
- Are there frequent procedures?
- Are procedures complicated?
- Are there subject diaries, electronic/paper?
- Adequate staff for trial?
- Additional training?
- Are visits complex, requiring many staff members?
- Is preliminary budget available?
- Is it adequate?
- Is budget line item?
- Up front costs non-refundable?
- Is payment schedule available and acceptable?
- Has cost been calculated?
- Is the project profitable?
Developing a thorough protocol feasibility checklist has been a learning process for Coastal Orthopedics & Pain Management, Dorman notes.
"You need to know what information they need to make the study successful," she says. "A lot of physicians might look at this and think they have these patients, but has a learning curve."
If the answer from everyone points to doing the study, then the next step is to complete a protocol feasibility report.
Dig deep to find essential information: Dorman does a little research to find answers to some of her feasibility assessment questions. For instance, sponsors often do not let CR sites know what their screen failure rate has been in previous trials for the drug/product.
"Sponsor will know what the screen failure rate is, and that information can tell you how hard the trial will be to enroll," Dorman says. "If they have a screen failure rate of 50 to 60%, then you know you'll only get a few patients."
But sponsors won't divulge this information unless sites request it.
Dorman also analyzes the study's inclusion/exclusion criteria and might ask physicians how many patients they see in their practice who might meet these criteria. She also has access to the patient database and can review the numbers of patients who have any particular diagnosis.
"I look at the trial itself to see how it's going to be reimbursed," she says.
Sometimes if patients have to bill their insurance for the study procedures, they might be less willing to participate in the study.
And if the study is going to be a long-term one with four or five years of follow-up visits, then it might be difficult to recruit many patients.
"Are your patients snowbirds or long-term residents," Dorman says.
"You figure you'll have a certain amount of drop-off," she adds. "I look to see if the study will be detrimental to us if we do lose 20% to 30% of patients after the initial visits, and I want to know how we'll get paid for this."
Also, if a study is longer, it's important to know if the sponsor is providing incentives to keep people enrolled. These incentives could be gift cards and other small tokens of appreciation.
It's also essential to understand precisely what types of procedures will be needed for a trial.
"We once did a phase II trial that would require many exams and labs, and my staff was not adequately trained on the physical and neurological exams that would have to be done on these patients," Dorman recalls. "So I went back to the sponsor and said, 'I don't think we know how to do this, and we're worried about the study time limit for completing them."
The sponsor agreed to provide training for the CR site staff, and that made the difference between the site rejecting the study and agreeing to do it, Dorman adds.
Sign-off on research protocol feasibility report: "Assessing feasibility is a continuous process up until we actually start the trial," Dorman says. "We have many procedures we go through, including having our research board look at it, and then I have another one-page sheet I send in, and it's signed by the physician, our corporate chief executive officer, and myself."
The feasibility report also is a simple, two-column table with one column for answers, and one column for these items:
- Name of trial/#/sponsor;
- Investigator coordinator;
- Start date/length of trial;
- Number of subjects;
- Physician involvement;
- Equipment needed;
- Total hours/visits per subject;
- Other costs;
- Total cost by trial;
- Total budget;
- Contract attached;
- Other information.
To conduct a suitable feasibility assessment, it takes everyone's involvement at the CR site, as well as several feasibility forms, Dorman says.
"It's our job as sites to get information about studies to make sure we can do the protocol," she explains. "It's only fair to the sponsor that we can make an intelligent decision and do the trial well at our site."