CT organizations could learn a lot from practices of brand-new sites
Focus on staffing, SOPs, equipment
Starting new clinical trial (CT) sites requires adequate staffing and equipment, proactive standard operating procedures (SOPs), and budgeting skills.
An expert who has experience in starting new clinical trial offices says organizations also need to know how to network and market the new site to be put on sponsors' radar.
"Sit down with your principal investigators to find out what kind of studies you want and are equipped to handle," suggests Cindy Mendenhall, CCTA, clinical research coordinator at Evergreen Healthcare in Kirkland, WA. Mendenhall has spoken about the logistics of starting new CT sites at national MAGI research conferences.
"I took one medical center's studies from zero to 14 in six months," she says. "The site did everything from pulmonary, oncology, cardiology, epilepsy, and diabetes studies."
Here is how the site achieved this success:
Don't skimp on staffing: New CT sites need to make research staffing a priority if they want to succeed. While one very energetic and talented clinical research coordinator could handle a large caseload of studies, what will the site do when that person is sick or on vacation? Plus, overloading one individual likely will result in burnout and the site's greatest asset quitting for a better job.
"You can't run the program with one person," Mendenhall says.
"You need at least two people at a site," she suggests. "You need one person who knows all the regulations and research and another who doesn't know everything, but can learn."
If a site is conducting cancer research then at least one of the CT employees should be a nurse with experience in oncology. But in most other CT sites, the main study coordinator does not necessarily need a medical degree background, she adds.
CT sites that struggle with funding issues should find creative ways to staff adequately, but affordably.
For instance, a CT site near or affiliated with an academic institution could create an internship for students in nursing and other medical programs, Mendenhall says.
"An intern could come in and work in research for a few months, which would help the student, as well as the research site," she adds.
Sites also could find volunteers who could handle some of the duties that clog up a study coordinator's time, such as running documentation to principal investigators for signatures.
"That's a big help and time saver since you have to sit around waiting for the PI to sign the papers," Mendenhall notes.
Write and follow basic SOPs: "I recommend using basic SOPs that include study feasibility, monitoring visits, informed consent, and drug accountability," Mendenhall says.
"It's important to have SOPs in place because if regulators come in, you'll need them," she adds. "Also, in research it's very important things are done in a standardized way."
For instance, an SOP might state how informed consent is performed. And the SOPs could include references to specific Food and Drug Administration (FDA) regulations.
"I pick up my federal regulations book and go through it to make an SOP from every regulation," Mendenhall says.
Install or ask for necessary equipment and space: It helps if a site coordinator and investigator have decided which kinds of studies they will take. Once they make this decision, they can assess the site's available space and equipment to see what additional items or space are needed.
"If you're doing a pulmonary study, make sure you are in place to have the equipment you need," Mendenhall says. "If you are doing diabetes studies, then invest in glucose monitors, blood pressure cuffs."
Studies often provide ECG/EKG machines, but a site could have one on hand, as well, she says.
CT sites can purchase the necessary equipment for very little, sometimes even obtaining used medical devices at no charge.
"It's good to save money every chance you get," Mendenhall says.
"With one study, we needed a refrigerated centrifuge machine, and I told the sponsor that we didn't have one of these and if they wanted us to do the study we'd have to have one," she says.
When the study ends, the site can then ask the sponsor if they'll sell the used machine at a greatly reduced rate. They often agree to this arrangement, she adds.
"Check your space to see if you have enough space to store all binders and files," Mendenhall says. "At the beginning of a study you might have 10 to 20 lab boxes, so where do you put those?"
Market your site to sponsors: New sites and any CT site that wishes to expand its research needs someone on staff who likes to network.
A study coordinator who works in a doctor's office or medical center could make business cards for the CT site with the coordinator's contact information. Then when pharmaceutical representatives visit the office or department, the coordinator could hand the rep a couple of cards and ask that these be passed on to the right individuals, Mendenhall suggests.
"Normally when I get the pharmaceutical representative's card I write on the back the name of the medical liaison and follow-up with the drug rep that next afternoon, " she says. "I thank the person for taking my cards and ask for emails of people to call about protocols."
The federal government's drug trial registry at clinicaltrials.gov might also prove to be a useful resource.
"You can call a company listed on the registry and ask if they are doing add-on sites for that particular study or if they have any other studies like that," Mendenhall says.
Sites could market themselves by showing sponsors that they have the necessary study population.
"The PI should make a de-identified list of patients who might qualify for the study," she says.
"This can help in negotiations too," she adds. "You can say, 'If we get your study, we have these patients who meet enrollment criteria.'"
CT sites that impress sponsors and clinical research organizations will get more studies and can quickly build on their success.
Develop a good budget: CT coordinators should learn how to develop a good budget.
"Talk with other centers and say, 'We're trying to get started, so what is your average budget for something like this?'" Mendenhall suggests.
"You want to be in the middle don't underprice or overprice your site," she adds. "Make sure that everything you do is good for the company."
Pay attention to details: Successful sites meet deadlines and attend to all necessary details.
"Make sure you're quick to fill in your case report forms or electronic documentation," Mendenhall suggests. "Make sure data are clean when the monitor comes out to visit, and make sure you don't have big holes in documentation."
Mendenhall creates a packet of necessary information for site monitors. The packet includes investigators and staff curriculum vitae's, licenses, human subjects protection certificates, and a note about the research site.
She also lists the site's equipment that would correspond with what the study requires.
CT sites also should check to see what certification they need for their studies, such as lab certification or phlebotomy certification when state or local laws require it, Mendenhall suggests.
"Make sure you have all of those things in place," she adds. "Talk with local research organizations to find out what you need."
Finally, new CT sites should have an outside audit or research consulting contractor audit them before they begin a research project, Mendenhall advises.
"It's always nice to have a second set of eyes," she says.
"An outside company can look over the SOPs, drug storage, equipment, training certificates, etc.," she adds. "This will assure you that you are ready to start your business and that you can concentrate on giving sponsors what they want: accurate, clean data."
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