Special Report: SoCRA Conference Coverage: Sub-sites help to meet recruitment challenges
Sub-sites help to meet recruitment challenges
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For many larger research institutions it is more efficient to contract with other research sites to be sub-sites in a particular study than it is to try to enroll subjects entirely at the main location.
The recent trend of declining clinical trial enrollment because of the negative publicity about drugs being pulled from the market after serious illnesses and deaths occurred has made it even more challenging for a single site to meet its recruitment goals alone, says Sylvia Dickinson, RN, MSN, CCRP, research clinical specialist at Vanderbilt-Ingram Cancer Center in Nashville. Dickinson spoke about coordinating clinical trial sub-sites at the 14th annual Society of Clinical Research Associate Conference (SoCRA), Sept. 23-25, in Lake Buena Vista, FL.
"Also, requirements for consenting patients are getting tougher, and you have HIPAA [Health Insurance Portability & Accountability Act], and it all makes it harder to accrue even one patient at one center," Dickinson says.
One solution is for the site that originates the trial to become a coordinating center, contracting with sub-sites. When this happens a trial involving a rare population might finish enrolling patients in a year or two, instead of five years or more, saving money in the process, Dickinson says.
"One of the main reasons for doing sub-sites at any level is to get your numbers of accrual and to get them as fast as possible, so you’ll have lower expenses, faster data, faster results, and quicker approval for drugs," Dickinson says.
The advantage to sub-sites is they might have something additional to offer patients who have exhausted existing treatment options, and they won’t have to refer them to a facility out-of-state for the research trial, Dickinson adds.
Dickinson, who is part of a regulatory staff of five, manages 24 sub-sites for various studies at Vanderbilt-Ingram Cancer Center, and the center probably has more than 40 sub-sites total, she says.
Also, a for-profit organization connected with the center has a couple hundred of trial sub-sites, Dickinson adds.
For years, the large consortiums, including the Eastern Cooperative Oncology Group, the Radiation Oncology Treatment Group, and others have looked at all phases of cancer and worked with smaller institutions that lacked the resources to conduct the more complicated studies on their own, Dickinson explains.
"What’s been falling through the cracks is how does an investigator who has a cutting edge idea for a research study get it off the ground?" Dickinson says. "Not many study sites have the expertise or equipment required to do these higher-tech studies."
Investigators at Vanderbilt-Ingram Cancer Center commonly come up with new ideas for cancer drugs and treatment and are required to file new IND applications or cross-reference INDs with the FDA, Dickinson notes.
As such, the cancer center becomes the coordinating site when principal investigators contract with researchers at other institutions to enroll subjects in their clinical trials, she says.
While most clinical trial administrators are familiar with regulatory requirements for being a clinical trial site, they may not be as comfortable with what’s required as a clinical trial coordinating center, so Dickinson offers these strategies for improving the coordination of clinical trial sub-sites:
• Simplify requirements for sub-sites.A coordinating center may follow good clinical practice (GCP) guidelines unfailingly, but it would be very time-consuming for the center to monitor and ensure that all sub-sites follow every detail in GCP guidelines, Dickinson says.
So it’s important to focus on ensuring sub-sites follow all federal regulations, she says.
"Everyone who is doing clinical trials has to adhere to FDA rules, but the guidelines, the good clinical practice guidelines, are guidelines, so I’m not going to nitpick over the guidelines," Dickinson says.
"We get a lot of sponsors coming in and monitoring us, and they all have their own standard operating procedures [SOPs] on how they want to have things done," Dickinson adds. "It gets to be very time consuming, and the federal regulations do not go into the detail that pharmaceutical companies and clinical research organizations [CROs] would like to require."
Dickinson says she keeps that experience in mind when dealing with sub-sites, who might view detailed monitoring as a harassment.
"I try to keep an open and friendly communication with sub-sites because I know down the road that the study might be audited, and I may need to ask them to send me stuff STAT," Dickinson explains. "And they need to know that when they get a fax from me they have to pay attention to it and not think, She’s calling wolf again.’"
• Keep a thorough tracking system. Dickinson uses an electronic tool that’s accessible throughout the hospital, so nurses can access it when enrolling a patient in a trial and data managers and study coordinators can use it to check on each sub-sites’ progress.
The tool is an electronic spreadsheet that holds multiple layers of data that can be accessed and understood by all involved, Dickinson says.
"The trial coordinator can pull up information to see if a sub-site is activated to enroll their first patient," Dickinson says.
The data manager receives information on eligibility screening logs, and then they have to track worksheet eligibilities for different amendments, Dickinson says.
For example, a sub-site may have been approved for amendment two, while the coordinating center has already been approved for an amendment three. The data manager’s job is to make certain the sub-site is enrolling subjects under the amendment two and doesn’t inadvertently use three’s eligibility, Dickinson says.
"Only the approved versions can be out and about at any one sub-site at any one time, and you have to know which version they’re using," Dickinson says.
While Vanderbilt-Ingram Cancer Center has no formal auditing program for sub-sites, the data manager and other clinical trial staff collect enough information to be able to catch any regulatory problems that might arise, Dickinson says.
"If needed we can require all of the information from the sub-site to be sent to us so an audit can be performed without going out to the site," Dickinson says.
• Communicate clearly and efficiently. "I educate them on what it is important to know about regulations, new amendments, and accrual numbers," Dickinson says.
Dickinson has created a fax cover letter that is designed to get sub-site staff’s attention and ensure their immediate response. The fax cover letter doesn’t focus on a study’s protocol number as the identifying feature. Instead, the fax letter has a bold-faced title, printed typically in 16-point Arial font, she says.
"The sponsor investigator’s name is there because a lot of people will link their train of thought to that too," Dickinson says. "And I make sure I list my name and contact information. I’ll also, in the comment section, bullet what’s included in the fax because sometimes not all the paper comes through."
The fax list quickly tells recipients the order of importance and when Dickinson needs the information returned.
"I try to make everything standardized so all forms look the same that go out to them," Dickinson says. "I have several reminder sheets so when the site alerts us that they are interested in being one of our sub-sites, I send this out about how to do an initial IRB submission."
Sub-sites occasionally don’t include a list of the documents that they are submitting to their IRB, but this is an omission that could prove costly since it’s usually something an auditor wants to see.
• Maintain monitoring control. Since coordinating centers are responsible for each sub-site, it’s important for the sub-sites to get the IRB submission information up front, Dickinson says.
"When a PI gives a sub-site to contact, I will send them an electronic form to fill out," Dickinson says. "That gives me contact information, tells me about their center, and then I know who I’m going to deal with from a nursing or regulatory perspective."
Also, Dickinson lets sub-sites know that the coordinating center will need to see their HIPAA document for the study, draft of informed consent, and other sub-sites’ IRB submission information before it’s sent to the IRB for approval.
This requirement is to ensure that the language used in the consent and HIPAA forms will not prevent the sub-site from sharing data with the coordinating center and to make certain they meet all FDA and other contractual requirements, Dickinson explains.
Likewise, the coordinating center is responsible for the dispersal of IND safety reports related to the study to all sub-sites, as well as keeping everyone on the team, including the nurse, data manager, and principal investigator, on the same page as to where the study is in the approval process, Dickinson adds.
For many larger research institutions it is more efficient to contract with other research sites to be sub-sites in a particular study than it is to try to enroll subjects entirely at the main location.Subscribe Now for Access
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