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Tech integration, alliances slow to improve
Integration within partners is happening first
There’s a resounding cry in the research industry for better technological integration and clinical research collaboration, but the movement in this direction has been very slow, an expert says.
Horizontal technology integration could lead to the widespread dissemination of best practices and electronic solutions, but there are no incentives to make this happen, says Dan Kerpelman, chief executive officer of Bio-Optronics Inc. of Rochester, NY.
"Say a site is working with a contract research organization or sponsor on a trial, and the site has information that’s relevant to other sites such as enrolling patient volunteers," Kerpelman says. "One site reaches capacity recruitment, but has patients who are available for the study, so why not offer up these patients to other sites that have openings?"
The answer is the site with extra potential volunteers has no motivation or incentives to share that information with other sites, he says.
"So they’re probably not asking their IT [information technology] vendors to provide better horizontal integration so they can integrate with their peers, who also are their competitors," Kerpelman explains. "That’s one issue that leads to a lack of collaboration."
The lack of integration has led to some ever-evolving job skills in some areas of the clinical research industry.
For instance, clinical research organization (CRO) monitors now have to learn a wide range of electronic systems in order to work with a variety of clinical trial sites and sponsors, says Laurel Bonner, RN, BSN, principal CRA with Wilmington, NC-based PPD, a global CRO.
"Within the last couple of years the amount of systems you need to learn has escalated," she says. "The more you use them the more familiar you are with their little quirks, but there’s definitely a learning curve there."
Technological integration in the research industry is still a distant hope rather than a reality.
"It’s been very slow simply because you have so many different systems out there, and to open that portability and connection with every single system is almost impossible to imagine," Bonner says.
A clinical trial monitor might be working with eight research sites and of those five are using electronic systems, and four of these might be entirely different systems, Bonner explains.
"So you have to know how to use each one so you can verify their data," she says.
"The training PPD provides us for every new technological system is pretty extensive," she says. "We are constantly evolving in this business, but it eventually will come to the point where we’re technologically saturated, and then it’s just a matter of keeping up with the changes within that [electronic] system, which may be upgraded because it’s constantly being tweaked."
In the case of vertical integration there are some incentives, but the technology provider industry in general does not address these well, Kerpelman says.
One solution is for research IT vendors to build collaborative tools that move up the network, starting at the research site level, he says.
"It’s easier to move up from the site than from the sponsor on down because of the sheer volume of sites and the experience you gain in doing this and understanding how sites work," Kerpelman says. "The reality is that trials win or lose at the site level, not in the headquarters of large multinational pharmaceutical companies, because the biggest risks are around things like recruitment, which happens by and large at the site level."
Companies like Bio-Optronics can improve vertical integration by facilitating work flow data management and financial management at the site level. As more sites adopt these solutions, they’ll also appeal more to clinical research organizations (CROs) and ultimately to sponsors, he says.
For example, Kerpelman’s health care and CR software company has a collaborative enterprise clinical trial management system (CTMS) called Clinical Conductor Enterprise that provides clinical trial management across studies and sites. This CTMS system, which is integrated across the clinical trial enterprise, manages and tracks everything from patient recruitment to financial management, Kerpelman says.
"For example, once a contract is awarded, the protocol is encoded in a language that allows it to be used in an automated fashion and to guide workflow for trial recruitment, such as eligibility, screening processes, enrollment, randomization, etc.," he explains.
Monitor visits can be governed by the electronic system, collecting and aggregating data from visits.
Another area in which collaboration and data integration are important involves billing for research activities versus hospital clinical activities.
"Say you have a health care practice or hospital department that provides health care, but also participates in clinical trials," Kerpelman says. "They have to be careful they don’t mix and match billing accidentally."
It could have major repercussions if a Medicare patient’s Medicare payer is billed for something that should have been paid as part of a clinical trial, he explains.
Research organizations could use two separate billing systems to ensure they are keeping these bills separate, but this is resource intensive and unnecessary when they have a large overlap of patients/volunteers, Kerpelman says.
The solution is to build technological bridges to the existing health records of the patients and volunteers, so there won’t be mistakes made that has a procedure being billed to the wrong payer, he says.
"You flag whether a procedure is trial-related or not and that allows the two systems to branch off independently of one another and then come back together for internal bookkeeping," he explains. "This is collaboration between a health care provider and the clinical trial site."