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CROs demanding greater electronic proficiency
Communication cycle is continuous, not quarterly
Clinical research sites increasingly will find sponsors or clinical research organizations (CROs) unwilling to send work their way unless they meet electronic and technological communication standards, experts suggest.
The shift to high-paced electronic communication has been accelerated because of a change in how pharmaceutical companies are working with CROs and other vendors. The new model for these relationships is called functional integrated provider networks, which means pharmaceutical companies are having CROs do more of the clinical research (CR) work they once did entirely on their own.
'The previous version was you had lots of vendors and you outsourced on a project-by-project basis," says Gregg Dearhammer, president of i3 Statprobe, a CRO in Ann Arbor, MI.
"The pharmaceutical company would retain responsibilities and tasks in-house and dole out work in a piecemeal fashion," he adds.
Now CROs will do more of the work they once retained in-house, including grant payments, contracting, and regulatory support.
From a CR site's perspective, this means that contacts the site once had with the pharmaceutical company are outdated. Instead, sites will need to work directly with the CRO.
And this shift will push sites to improve their technology and electronic data capture (EDC) capabilities since CROs are motivated to make the clinical trial process as efficient and fast as possible.
"The CRO makes its money by being as efficient as possible," Dearhammer says. "CROs have to improve efficiency while maintaining quality, so trial sites will see a greater push toward automation, electronic communication, and those types of things."
Pharmaceutical companies are not far behind in that technological trend, but CROs are leading the way because it's critical to their making their profit margins.
CR sites that are lagging behind in technological advancement will need to make investments in both electronic systems and in personnel. A first step might be to hire an information technology expert who can work with and educate investigators and study coordinators in finding electronic solutions that they can use in their workflow.
"We bring in technology, security, and the power of technology, and then we attempt to hide it so you don't have to learn the new technology if you don't want to," says Al A. Cecchetti, PhD, co-director of the Clinical Pharmacology Data Center at the Center for Clinical Pharmacology, University of Pittsburgh Department of Medicine in Pittsburgh, PA.
A research information technology expert can create electronic forms that flow identically to paper forms and that can be scanned into a database, he adds.
The goal is to move a study site to electronic data management by creating templates and work processes that will satisfy the most high-tech CR staff while meeting the needs of the paper-and-pencil researchers, Cecchetti says.
Change is the constant
Technological demands are only part of the change CR sites are experiencing as CROs handle more of the clinical study process.
From a CR site perspective, this shift from dealing with sponsors to working entirely with CROs is a whole new world.
"It's not like the old days when a CRO did monitoring and data management and was the arms and legs of the pharmaceutical company," Dearhammer says.
"Now, companies like i3 are being asked to bring scientific and therapeutic expertise to the table," he explains. "This includes having a physician who can help with protocol development and a health economist who makes sure you're doing analytics on the cost effectiveness of a drug prior to market."
CROs like i3 will bring highly scientific services to the table, broadening their role to encompass clinical trial execution.
"Pharmaceutical companies might have had these roles, but have now decided they don't need them or as many of them, so they'll outsource that work," Dearhammer says.
Small-to-midsized biotech and pharmaceutical companies might not build a staff with that expertise, instead contracting with CROs to provide the scientific staff. Big pharmaceutical companies will continue to retain scientific knowledge in-house, but will supplement it with outsourcing to CROs, he adds.
As this transformation takes place, clinical trial sites will need to improve their own efficiency and technological capabilities, particularly from a data services perspective.
"Sites need to ensure they're complying with the timelines required as much as possible," Dearhammer says.
"For example, having data entered electronically only works really well if the investigator goes into the system and enters the data or updates information in a realistic time frame," he says.
From the CRO's perspective, this means data are entered in small doses in real time.
"When a patient has a visit, you go in that night and enter that visit," Dearhammer says.
Principal investigators and CR sites might be accustomed to submitting data on a monthly or quarterly basis, but this no longer will work.
"Letting weeks and months go by before going into the system and entering data defeats the whole purpose of electronic communication and data capture and creates real problems downstream," Dearhammer says.
CR sites that continue to wait weeks before entering data will have CRO representatives calling them repeatedly. CRO monitors might call to ask for 20 hours of the site coordinator's time to resolve the backlog of issues, he adds.
"It creates more chaos and urgency, which no one likes," Dearhammer says. "So you have to take 10 minutes a day instead of six hours at the end of the month, sending in data in small doses, or answering a query immediately and fixing the problem."
CROs typically are willing to work with investigators and study coordinators to help them make the transition to real time data entry.
"We're there to support them and we do that by ensuring investigators are entering the right information in the right timeframe as required by sponsors," says Tracy Tsuetaki, president of i3 Research of Basking Ridge, NJ.
"Training is key, so we provide face-to-face training at site initiation visits," Tsuetaki says. "The CRO is the first person the site will call with any general questions about the system."
CROs will monitor sites on a continuous basis, making certain all data are entered in a timely manner, which largely means within a 24-hour timeframe, he adds.
Sites that fail to keep up with the faster EDC pace will find they're held accountable by CROs and are called until they're compliant.
CROs can predict based on a study protocol when patient visits take place, Dearhammer notes.
"If the protocol calls for a visit every six months and the first visit is July 1, then the second would be Jan. 1," Dearhammer says.
"So if on Feb. 1, we see there are no data entered in the system for visit 2, we'll give that information to the clinical monitor, and someone will call the site," he explains. "We ask if the visit was missed or if its on the side somewhere waiting to be entered into the system, and we try to prod them to comply."
Some investigators will respond to the gentle nudge, and for others it might take several phone calls, he says.
CR sites would do well to accept the trend and prepare for technological improvements. The investment is costly but will pay off over the years, Dearhammer says.
Meantime, CROs will continue to push this trend, asking investigators specific questions about how comfortable they are with using electronic records, he says.
"A lot of our screening process with people is to see if they'll comply," he says.
"But the overriding thing is whether or not a physician can put patients on this study," Dearhammer adds. "If the physician says, 'I'm not comfortable with the electronic technology, but I can deliver 20 patients,' then you'll build in coaching, prodding, but not eliminate them from the study."