The Imperative to Support Site Adoption of EDC

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.

Kenneth A. Getz

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.

"We've got more than a half dozen computers that all do the same thing, but with a different interface," said an investigator based in Atlanta. "That requires more space and more training. Although multiple sponsors may use the same EDC solution, we can't get them to communicate," he stated.

Several investigative sites commented that their offices are becoming cluttered IT jungles. "We're having a lot more trouble finding outlets to download PDA data," said a site manager, who also offered an example. "On one recent afternoon, 25 PDAs were downloading information from a Web server and another 15 were in the queue."

"EDC definitely eliminates the hassle of storing paperwork and is a superior method of answering data queries," said a study coordinator. "On the other hand, data entry is slower and there's an occasional logjam when all seven coordinators want to input their data at the same time. Our coordinators each have six to eight studies—that would require way too many laptops," she added.

"The necessity to add and remove users so that coordinators can enter data is often difficult," commented a site manager. "Many times, sponsors only allow a set number of users per site. Helping other coordinators with their data entry is one of the easiest ways to assist each other—but with limitations on the number of users, EDC hinders this aspect of coordinating."

EDC increasing workloads

According to the CDISC survey, approximately one out of four sites report that their workload increased when e-clinical trial technologies were used. Increases in workload are largely due to sites creating paper back-up when eCRFs were used. "It's still more convenient and safer for me to transcribe information into a CRF than to use all these different databases," said a site manager. "I've just got more peace of mind knowing that I've got a hard copy."

Only one third of investigative sites surveyed by CDISC report learning that a given trial will use eCRF and ePRO technologies during the request for proposal period. Although use of eClinical technology solutions at the site may increase workload, most sites are not compensated for this. The failure to communicate at the outset that eClinical technologies will be utilized gives the site incomplete information and sends a message that the site is not considered part of the team. As a result, study staff report ambivalence and some reluctance to get involved in e-clinical trials.

Several sites admit that the situation is improving but still has a long way to go. "Our overall experience with help desks is a lot better this year compared to last year, but there are still a lot of bad ones out there," said a study coordinator based in Denver. "For one of our studies, we now receive notations on a Web site whenever patients call for technical support. And many companies send us quarterly updates that address technology glitches, such as a return button that doesn't respond to the first hit," she added. Several larger sites report now having an information technology specialist on staff to troubleshoot with the help desk provided by the sponsor.

The fact that many help desks are manned from places like Singapore and India doesn't appear to be a major issue for investigative sites. "Problems are generally corrected while we're on the line," said one site manager. Another commented, "One year ago, I would never have given such a positive report for help desk support coming from overseas. It has gotten better."

Competing pressures

Increasing economic pressure on sponsors to conduct clinical research faster while improving safety; greater integration and access to clinical research and patient health care data; continued market consolidation; access to investment capital; and regulatory reform promoting acceptance of standards and systems compatibility are widely considered market forces that will facilitate electronic clinical trial technology adoption. Added among these forces should be the acknowledged need and the imperative for sponsors to provide greater technical support and emphasis on engaging investigative sites as partners in the adoption process.

Kenneth A. Getz MS, MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, Massachusetts, email: kengetz@ciscrp.org