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Technological changes give CR sites more options for running business
Training has increased for monitors
Clinical research technology continues to evolve at a pace that’s difficult to fathom. Everything from study recruitment to budgeting to operations are changing and evolving because of technological advances.
Some areas are transforming rapidly as major research and health care organizations invest in electronic data collection solutions and make paper-based research processes increasingly obsolete.
"Universal electronic medical records have the potential to transform research," says T. J. Milling, MD, FACEP, director of medical research at Hospital Physicians Clinical Research (HPCR) in Austin, TX.
"In the last couple of years we’ve set up email alerts based on certain lab values or presentation of complaints, which is easier than sifting through every patient record," Milling says. "Communication by email and cell phone calls takes less real time than a few years ago with the ability to text back and text pictures."
At Dana-Farber/Harvard Cancer Center in Boston, MA, the health system’s electronic data capture (EDC) system has reduced research data entry workload, improved data quality, reduced turnaround time for study analysis, and increased efficiency, says Marina Nillni, PMP, EDC program manager at DFHCC. Dana-Farber/Harvard Cancer Center is a consortium of Harvard University-affiliated hospitals.
The EDC also has led to an annual increase in clinical trials since the EDC was installed six years ago, Nillni says.
But it’s the improved efficiency that most impacts research staff.
"The electronic data capture system allows us to do an electronic check, so we can correct problems right away," Nillni explains. "In the paper world, two months would go by before you’d get a [corrected] data form."
As a result, investigators are able to publish and submit grants faster, she adds..
For clinical research organizations (CROs) and monitors, technological changes have ramped up their need for continual training in recent years.
"When I started as clinical research associate 10 years ago, we had one or two areas of technology we had to keep up with: one was in training and the other was where we wrote our reports," says Laurel Bonner, RN, BSN, principal CRA with PPD, a Wilmington, NC-based global clinical research organization.
"In the last three-to-four years I can count upwards to 10 different technological systems I’ve had to learn proficiently in order to do my job," Bonner says. "It continues to evolve."
Each new technological solution also comes with a new challenge, experts say.
One of the chief issues involves interoperability or collaboration between entities using the systems, says Dan Kerpelman, chief executive officer of Bio-Optronics Inc. of Rochester, NY. Bio-Optronics develops software products and information technology solutions for the health care and clinical trial industries.
Technological advances in clinical trials are increasing as sponsors, contract research organizations (CROs), and sites increasingly adopt electronic management for data, operations, inventory, labs, projects, and customer relations, Kerpelman says.
"There is an increase in penetration in all of these systems in clinical trials, but these are not matched by an increase in interoperability or collaboration between all of these systems," he explains. "The increase in adoption creates greater need for interoperability and collaboration, but the industry has not followed with this."
One reason for the lack of interoperability is that in a free market economy, companies will select solutions that work best for their particular organization, which does not translate into a solution that is compatible with potential collaborators or competitors, Kerpelman notes.
"Coming up with a solution that ensures the system interoperates with other systems in the clinical trial enterprise is not just the responsibility of technology providers, it’s also the responsibility of technology users," he says.
Even if technology companies were able to design interoperability between research electronic data capture systems and hospital electronic medical records, there are major obstacles to this working in any useful way, Nillni says.
For one thing, the two types of data systems collect information in different ways to suit different purposes. For research, data must be very systematic and organized in a way that facilitates statistical analysis and comparison. For health systems, electronic records are more descriptive with more free text because they are used for documentation and not for analysis, she explains.
Secondly, large research organizations might have clinical trials around the world. An interoperability solution that works in the United States likely would not work in Canada, Europe, Asia, or Africa, she says.
"So the challenge is there has to be some level of abstraction from the medical record," Nillni says. "I don’t think we’ll see that type of integration anytime soon."
Some of the latest technological advances hold promise for seamless clinical trial marketing and advertising. For instance, CR sites find that Internet advertising for a new trial can provide a very efficient and quick link that sends interested parties directly to the trial website where they can easily request to be contacted via email or a phone call. Some basic screening also can take place this way. This approach reaches only the people who pay attention to advertising online, however.
Now there’s a possible new approach that would provide the same seamless link between potential recruits and CR sites in public locations. So, people who are waiting at a subway station, walking by a billboard, or browsing through a magazine could directly link to the CR site’s recruitment page. It’s called 2D barcode technology, which consists of large data barcodes that look like a square blot matrix.
For instance, research sites could place billboard advertisements in public places frequented by a target audience that relies on mobile phones for communication and Internet needs. As people walk by the advertisement, they could point their phone at the advertisement’s 2D barcode, photographing it. Then the code will direct them to a website where they could learn about the new study. The study site’s computer would send the person a text message that requests a reply if they are interested in hearing more about enrolling in the study.
"We do patient recruitment using short codes now, but no one is doing the 2D barcodes yet," says Tim Davis, BSc, chief executive officer and co-founder of Exco InTouch Ltd. in London, England. Exco InTouch is an interactive mobile technology company that designs technology solutions for clinical research recruitment, compliance, and data collection.
This technology could pass IRB muster because the individual’s consent can be implied by the act of photographing the 2D barcode, Davis says.
"If they wanted to add a second step, they could [have a pop-up] ask, Are you sure you want to do this?’" he adds.
Technology also exists to allow research study visit encounters between a subject and study coordinator who might be 500 or 5,000 miles apart.
"The potential is there, and we’re looking into it," Milling says. "You could have interactive face-to-face conversations."
While there might be some initial regulatory barriers to this, it is possible technologically, he adds. "The regulations will follow; the high speed Internet is there, the technology is there, and it’d be a shame not to use it."
Another new step is to use eDocument technology for signatures.
"Our industry is awash in paper, and it takes time to get paper to the right person to sign," Milling says. "Being able to get the signature by email will save time; we have the software for this, and it should be up and running in the next few weeks."
One of the benefits of the research industry being late adopters of electronic technology is that it requires slightly little less staff training when new electronic systems are implemented, Milling notes.
"Everybody we hire is skilled at email and word processors and spreadsheets," he says. "Most people have been working on those things for 10 to 20 years."