Kenneth A. Getz
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In the coming three years, the market for electronic data capture (EDC) and electronic patient reported outcomes (ePRO) technologies
is expected to grow faster than its historical 23% annual rate. Several key factors are expected to drive adoption, including
growing regulatory and organizational support for data interchange standards; continued market consolidation; improved availability
of investment capital; and improved vendor functionality and performance. Engaging sites as more active partners in EDC decisions
and providing more responsive technical support should also be recognized as a critical adoption driver.
A few years ago, investigative sites were almost unanimously frustrated by the unmet promises of technology solutions. Today,
sites are far more receptive to EDC and ePRO, but many feel that they are entering into a commitment to adopt these solutions
without the full and necessary backing of research sponsors. Sites are particularly concerned about the variability in technical
support availability and responsiveness, the lack of compatibility between sponsor data collection systems, and the failure
of sponsors to inform sites that eClinical technologies will be used at the outset of an engagement. As a result, many investigative
sites are reluctantly and cautiously adopting eClinical technology solutions, often relying on paper-based approaches as an
insurance policy against inevitable problems.
A recent survey conducted by the Clinical Data Interchange Standards Consortium (CDISC) among 150 North American clinical
investigators and study coordinators finds that most investigative sites are preparing themselves for the electronic age of
clinical trial conduct. Almost all sites report having dedicated staff now trained on electronic case report form (eCRF) and
ePRO systems. More than half of sites report having developed standard operating procedures (SOPs) specific to eClinical trials.
But technical support, particularly for ePRO systems, is one of the largest aggravations for investigative sites. According
to the CDISC survey, most investigative sites want to see more responsive technical support. More than half of investigative
sites report specifically having technical challenges with ePRO technologies, most notably among their elderly study volunteers.
Investigative sites typically must turn to the study coordinator for help—an individual who is often the least equipped to
troubleshoot problems. Some sites report that even when an actual help desk has been established, it often is unable to troubleshoot
as well. "At an investigator or initiation meeting, the coordinator typically receives cursory training on the equipment, but of course
cannot function as a help desk," said one site director at a research center based in Salt Lake City, Utah. "One recent study
was a total disaster," she said. "Participants had palm pilots they entered data into and downloaded daily. But the devices
didn't work consistently, the phone number to call for downloads didn't function properly, and it was extremely difficult
to get answers from the help desk based in another country. Unfortunately, the participants associated the problems more with
my site than with the sponsor company."
"Sites really need not only better training, but also written instructions to give participants when ePRO is being used and
a protocol-trained help desk with 24/7 availability," suggested a study coordinator at a site based in the New York area.
"We find that some help desks are always available, but never helpful when it comes to anything protocol specific," said a
Cincinnati-based site manager. "And the sponsor is rarely ever helpful when answering technical questions. Most questions
have a technical component as well as a protocol specific component. That means the site may have to contact multiple people
to get one question answered."
Fallout from tech issues
The fallout from inadequate technical support is a time delay for the research sponsor and lost time and revenue for the investigative
site. "If study participants can't get the data downloaded that continues to qualify them for a study, they may quit or they
may be dropped from the study," commented a study coordinator.
Investigative sites remain adamant that sponsors should collaborate to better standardize data collection systems, if only
to reduce the mounting number of incompatible desktop and laptop terminals. The CDISC survey found that the typical investigative
site has an average of three disparate systems to capture transcribed CRF data. Complicating the issue is that many sponsors
have fashioned their own proprietary EDC systems that require unique training and support. With increasing turnover among
study coordinators, investigators and site managers often face the challenge of having to rapidly train new staff to stay
on top of electronic data collection activity.
