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Electronic research: From leaders to laggards
Sites find enhanced productivity, flexibility
Electronic research management is transforming the way researchers work, communicate, and execute studies. It's also making the clinical trial (CT) process more efficient, flexible, and faster, 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.
Electronic management - clinical translational research (eM-CTR) systems use a novel, integrated strategy to support and manage trials.1
The eM-CTR system is a technological answer to questions the National Institutes of Health (NIH) posed seven years ago when the NIH Roadmap for Medical Research was published. NIH now calls the program "Re-Engineering the Clinical Research Enterprise initiatives."
NIH introduced the concept of translational research, asking the CT industry to imagine future studies in terms of how researchers will communicate between teams and how to engage all of the necessary research parties in pursuing a single study research goal or purpose.
"How do you get people who are diverse personalities and in diverse settings to work together?" Cecchetti says. "So eM-CTR was designed to do that."
The eM-CTR system also is a team-building process because CT staff can more effectively communicate and stay up-to-date on research data collection, Cecchetti says.
Cecchetti describes the advantages of eM-CTR and how it can be implemented and used at CT sites:
Know technology expertise of staff: The first step for any CT site is to understand the members of the team and how they relate to technology.
One framework that might be helpful in identifying CT site staff's abilities and educational needs in new technology is the technology adoption lifecycle model developed by Joe M. Bohlen, George M. Beal and Everett M. Rogers at Iowa State University in the late 1950s.
While the social scientists initially created this model to follow hybrid seed corn purchasing patterns, the basic principles can be applied to how people accept and adapt to the current electronic technology revolution, Cecchetti says.
"Your first group includes the innovators who walk in with the newest technology, maybe the iPhone 4," he says. "They tend to be a little annoying, using the technology all the time."
The next group is the early adopters, who might be sending emails while at meetings, checking for information on their laptop or cell phone, he adds.
"The early adopters tend to be leaders of groups and who also know how to use technology well," Cecchetti says.
Late adopters comprise the third group.
"These are people who use computers in their office to check emails, and they won't use technology at meetings," Cecchetti says.
Finally, the last group are the laggards, and possibly every CT site could identify one or more of these people.
"The laggards are the ones who use paper and pencil," Cecchetti says.
The idea is that any new technology implemented at a site will be used first by the innovators, followed by the early adopters, and then the late adopters. CT sites might have to find alternative solutions for the laggards.
"Some people will grab the new technology, put in their own statistical program, and off they go," Cecchetti says. "Others will want to see electronic charts and graphs and not create these on their own, and still others want the charts printed out."
If a CT site has a high number of innovators and early adopters, then the transition to eM-CTR might be a fairly smooth one. For sites that have more laggards than innovators, then the transition might require an information technology specialist who works with staff until they either can use the technology on their own or until the site has work-around processes in the cases of people who won't change their documentation habits.
"You have a clinical coordinator who is in charge of the study and who works with subjects, and you have an information officer who is in charge of the technology," Cecchetti says. "My job is to make sure the technology works for the people."
So if a laggard technology adopter continues to use paper records, then this can be scanned into the system. Or a CT site's information technology expert can create an electronic form that is similar to what investigators and coordinators already are using.
"For laggards you may hide the technology more than you would for the innovator," Cecchetti says.
Enhance work productivity and flexibility with technology: New technological solutions can save researchers and coordinators time, Cecchetti says.
For example, an older technological process created charts for genetic information. While the information could be more easily updated than the paper and typewriter system, it still required someone to review the data, find the desired numbers, and put these into the correct database and then send them off for analysis, he says.
With a state-of-the-art electronic hub design, there now is an application that enables a person to upload the original document to an information hub. The system can pull information from the uploaded document and automatically put the desired information in a database, he adds.
Depending on the data's sensitivity, it can be password encrypted, scanned, and made available to everyone who needs to view the information.
"So we streamlined that operation," Cecchetti says.
Electronic management systems that include the latest communication technology can help staff complete work and meet deadlines while still catching flights to conferences or taking time to watch their children's soccer games, he notes.
"We have had people who have gone to the airport, talked to the lab staff, and sent information in full [electronic, remote] meetings before they even get on a plane," Cecchetti says.