According to a recent industry survey, on-site clinical trial monitoring is estimated to account for up to 30 percent of study costs and, according to some, is very inefficient. The results published in a coinciding research paper by members of the Clinical Trials Transformation Initiative (CTTI) suggest that sponsors are missing an opportunity for significant increases in clinical trial efficiency, specifically in monitoring processes. More monitoring does not mean more quality.
Careful monitoring is a necessary and important part of any clinical trial — so necessary and important, in fact, that it has changed very little over the history of conducting clinical trials. Required by both U.S. and international agencies, clinical trial monitoring helps ensure the integrity of the data, the consistency of the science, and of course, the safety of the patient.
Today’s clinical research associate (CRA) may monitor several concurrent studies, with all the associated travel, management and reporting responsibilities. Burnout is a constant problem, as CRAs endure separations from their homes and families while fulfilling their professional responsibilities at multiple sites. It can be a challenge for clinical research organizations (CROs) to retain trial monitors due to the demands of the job.
However, improved technology adoption and clinical operation processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time (JIT) Monitoring that is dramatically changing the way we interact with our trial sites.
With JIT monitoring (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.
A key aspect of realizing the benefits from just-in-time monitoring is to actually incorporate the data-driven model into clinical trials. Many study sponsors and sites are using technology to collect and store trial data, but haven’t taken the next step to integrate the data from disparate systems into meaningful information.
In these cases, technology-amplified service delivery is not much more useful than collecting it manually, and in fact adds an extra step to the process. To avoid being burdensome, data collection tools must be incorporated into the overall study framework in a way that encourages their use as part of conducting the trial. Furthermore, the data from laboratory and clinical systems must be viewed as a whole in order to glean real intelligence from the data stream.
Ultimately, data-driven solutions result in enhanced outcomes for the research sponsors and better relationships with the sites. And providing cleaner data on time and under budget can make CROs more successful.
While just-in-time monitoring is an excellent way to increase efficiencies and reduce costs, it doesn’t remove the need for careful on-site monitoring to ensure adherence to protocol and attention to patient safety. However, it can elevate those on-site visits to make them more focused, more strategic and less disruptive to patient care.