What Monitors Think of EDC

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-05-01-2003,

For years, EDC providers have claimed that the technology can increase efficiency and potential cost savings. Survey results indicate that clinical monitors agree.

Electronic data capture is rapidly being adopted to gather clinical trial data. For example, a recent survey found growing acceptance and use of EDC technology for clinical trials.1 More than 75% of the respondents are involved with more than 10 trials per year-and only one-third of those responding to the survey have yet to use EDC. In addition, a recent analysts' report found that among the top drug companies, web-based EDC technology was ranked the "most important" IT initiative in their drug development programs.2 Despite the numerous articles that have evaluated the return on investment (ROI) for EDC projects from a sponsors point of view, few objective analyses have been performed to evaluate the impact of EDC from a clinical monitor's perspective. Consequently, we conducted a survey to evaluate what clinical monitors think of EDC technology.

Figures 1-6

Specifically, the survey was developed to determine the following: monitors' general knowledge of EDC, their experience or knowledge of various platforms, their perceptions of positive or negative characteristics of EDC, their recommendations for EDC providers, and their estimates of the future of implementation of EDC programs in clinical trials.

Survey questionnaire

We developed an 18-question survey that contained open-ended and forced-choice questions. It was divided into three sections: personal background information, overall knowledge and experience with EDC, and specific characteristics of EDC. Surveys were broadcast faxed to approximately 335 monitors registered with our company; 96 monitors responded within 10 days.

Personal background. The first section of the survey was designed to develop a profile of the responding monitors. The data showed that they were experienced monitors; 63% had more than five years of clinical monitoring experience (Figure 1). They were evenly distributed across the United States.

Experience with and knowledge of EDC systems. The second part of the survey addressed the monitors' experience and knowledge of EDC systems. Respondents spontaneously generated the names of 13 EDC companies with which they were familiar (EDC providers sidebar).

This section of the survey also sought to gather specific information about respondents' personal experiences with EDC. More than half (54%) of the respondents indicated having direct experience with EDC systems; the majority indicated their experience had occurred during a Phase 3 trial (Figure 2).

Positives and negatives. Interestingly, respondents were evenly divided on the number of positive and negative comments heard about EDC systems. Half indicated hearing negative things about EDC and half indicated hearing positive comments about their peers' experiences with EDC systems. Respondents were prompted to indicate the positive and negative aspects of their EDC experiences.

They reported that the best-liked characteristics of EDC were the reduced number of queries and reduced time on site (Figure 3). As a corollary, the majority of monitors indicated that the reduced number of queries allowed them to spend more time with the investigators and staff rather than with reconciling queries.

In contrast, the respondents indicated that the aspects of EDC they liked least were the training and the technology support provided by the EDC vendor and the "slowness" of some systems (Figure 4). Follow-up inquiries with the respondents revealed that the slowness they disliked can probably be attributed to the connection speed rather than the actual processing of the EDC systems.

Support suboptimal. Monitors clearly noted, however, that the support/help desks of many vendors perform at suboptimal levels. They specifically mentioned that it was obvious that a number of help desk operators had no experience in clinical trials and did not understand the difference between a coordinator and a monitor. Furthermore, respondents indicated that numerous issues arose with help desk coverage across time zones, and they encountered pronounced compatibility challenges between some EDC systems and their office computers.

Specific characteristics of EDC. The last section of the survey provided some of the most interesting results. For example, 62% of the respondents recommended that EDC vendors provide preprogrammed laptop computers preloaded with EDC software. This recommendation clearly points out some of the early technical challenges monitors have had with systems that were not browser- or thin client- based. (A thin client system is one designed so that most data processing takes place on a server rather than on a desktop computer.)

Moreover, 24% recommended providing online training for clinical monitors (Figure 5). However, despite some of the challenges of EDC systems, over 70% of clinical monitors rated their experience with them as positive. An even more compelling 96% of clinical monitors would recommend the use of EDC on their next clinical trial (Figure 6).

More good than bad

Although clinical monitors who responded to our survey reported a number of concerns with EDC providers-specifically, technical compatibility and support-an unprecedented majority of clinical monitors indicated their preference that EDC systems be used. They cited such advantages as a reduced number of queries and reduced time on site. Those advantages are consistent with the claims of EDC providers who cite the systems' potential for increased efficiency and cost savings.

We also captured information about monitors' initial thoughts on the future of EDC implementation that suggests that they expect EDC to become a fundamental technology in future clinical trials-but not immediately. Although 68% responded that they do not expect EDC to be used in a majority of clinical trials within the next two years, 81% of the respondents said they expect EDC to be used in a majority of clinical trials in the next five years. As a group, clinical monitors may be among the strongest advocates for adoption and implementation of EDC technology for clinical trials.

References

1. Lisa Roner, "Survey reveals EDC use on the rise for clinical trials," Eye for Pharma, (10 May 2001).

2. 2001 Drug Development Services Market Survey-Finding Reality Within the Contract Research Marketplace (Bear Stearns & Co., Inc., 383 Madison Ave., New York, NY 10179).

Rod M. Saponjic*, PhD, MBA, is senior vice president for MonitorForHire.com, 5752 Oberlin Dr., San Diego, CA 92121, (858) 453-8030, fax (858) 453-8040, email: RequestInfo@MonitorForHire.com, www.monitorforhire.com. Scott Freedman, MBA, is president or the company; and Ali Sadighian is manager, Clinical Operations.

*To whom correspondence should be addressed.