Several months ago, Christine Pierre and I discussed the myriad burdens sites face as clinical research becomes ever more complex. We agreed that Clinical Ink and the Society for Clinical Research Sites (SCRS) shared the same desire to educate the industry about what I termed “the plight of the site.” To better understand how sites actually conduct research, Clinical Ink, SCRS and CenterWatch partnered to develop a comprehensive survey of site activities related to that critical moment in a clinical trial—the patient visit.

In the February issue of The CenterWatch Monthly, the article “The need for—and barriers to—adopting eSource” summarized the survey findings in the context of eSource adoption. For example, 79% of sites prefer to capture source data electronically instead of re-entering data into a separate electronic data capture (EDC) system. A deeper look at the survey data reveals significant insights into what is actually driving research activity at the “point of care.”

In the survey, 656 sites from 29 countries answered forty detailed questions about how they prepare for and conduct clinical visits with a particular emphasis on how source data are documented. The survey segmented responses by site type [Academic/hospital (184), Practice-based (254) and Dedicated Research (218)], study experience [<10 (181), 11-20 (215), 21-30 (104), and >30 (156)] as well as geography in order to identify differences in work practices.

The most critical findings relate to how sites document the proper execution of the protocol. If the protocol isn’t executed consistently across all sites, then the data are suspect and, in the worst cases, can lead to inaccurate conclusions about efficacy and safety. Prior to the patient visit, 90% of sites create study-specific source documents, spending an average of 19 hours doing so. The most commonly cited reason for creating source document templates is to ensure all protocol-required activities are properly documented (90% citation rate).

Despite the prevalence of electronic medical records (EMRs) and EDC systems, a staggering 96% of sites create source document templates in Word/Excel/PDF. One common but baseless interpretation of this finding is that “sites don’t want to use technology.” However, the real reason paper source continues to dominate clinical research is two-fold:
The vast majority of study data are generated solely for the purpose of documenting protocol compliance—68% of all sites estimated that more than half of all study data were generated specifically and only for the purposes of the study. As the chart above shows, this can vary significantly based on the type of sites involved, which is also highly correlated with the therapeutic area being studied (e.g. oncology studies are more likely to be conducted in an academic/hospital site where the standard of care is augmented with study-specific procedures).

EMR systems are incapable of capturing source with the detail and specificity required by the protocol—69% of all Academic/hospital sites (those with the most sophisticated EMR systems) explicitly stated that the EMR system was incapable of adequately documenting protocol compliance. For example, the EMR can capture vital signs, but can’t determine if it’s standing or sitting or if there is a time offset (e.g. wait five minutes and take a second reading).

Interestingly, the survey showed no significant differences across geographies with respect to the response rate for creating paper source, the rationale for creating study-specific source, the percentage of study-specific data being captured and the inadequacy of EMR systems to fully document protocol compliance.

Regardless of the supposedly innovative efforts to conduct “site-less” trials, the backbone of the pharmaceutical industry will always be well-trained, productive research sites. Consequently, it is imperative that we understand how sites actually work at the point of care. Critically, the concept of eSource is not just about eliminating data entry—that puts the focus on the “e” in eSource. Rather, the focus needs to be on “SOURCE”— source data and documentation are unequivocally the most important evidence of how the study was conducted. Year after year, inadequate record keeping and failure to execute the protocol are top regulatory inspection findings. To address the plight of the site, we need to help them document source electronically, thereby improving protocol execution and reducing complexity at the point of care. 

This commentary was submitted by Ed Siguine, CEO of Clinical Ink.

This article was reprinted from Volume 24, Issue 03, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>