The frenzy of technological development currently taking the research industry by storm has worked wonders in the way of modernizing clinical trials. Much of this, as we discussed last week, entails the utilization of technology developed outside the industry, such as social media, to enhance patient engagement and other aspects of clinical research. But the clinical research industry’s technological savvy is not limited to this kind of resourcefulness: other innovations, developed specifically for clinical trials, have become indispensable tools for counteracting the rising costs and heightened time sensitivity of research today. The marquees name among these innovations is eSource. By allowing data managers to enter patient data directly into an EDC system without any intermediary transcription from paper, eSource opens the door to monumental savings in time and money.
One aspect of clinical research in which some of the most significant of these savings occur is in monitoring costs, which can comprise up to 40% of the total cost of a clinical trial. Typically, in-person site visits, between flying in monitors and preparing sites, can run up quite a bill. eSource makes it possible to share data digitally, thereby allowing monitoring to be performed remotely. It also represents a breakthrough in source data verification (SDV). The process of ensuring that paper records match the EDC system into which they’re transcribed–that no data value is mistakenly changed during transcription, that data isn’t matched to the wrong subject, that no duplication occurs–can be costly and time-consuming; CROs equipped with eSource are relieved of this task: fewer errors to catch means less monitoring work.
How eSource helps in Phase I
Clinical trials of all phases incur the costs associated with monitoring, but other costs can be particularly acute in, or exclusive to, certain phases. Phase I trials, for instance, carry a number of time and cost considerations that may not be such a burden to trials of other phases. One source of these concerns is the disruptive effect of protocol amendments, which occur most frequently in Phase I1. This tendency is reflected in the increasing complexity of Phase I trials, which triggered a 157% spike in staffing costs between 2008 and 20132. Other costs specific to Phase I center around the patients. These trials often experience high dropout rates, whether due to the “guinea pig” fear – many potential recruits are averse to receiving a treatment for which safety data and dosage levels are not yet known – or to the absence, in many healthy volunteers, of motivation to participate aside from the financial. The result can be recruitment costs and trial delays that place significant stress on a study’s budget. (A more comprehensive list of Phase I cost drivers is discussed here.)
Time can also be a sensitive aspect to Phase I. In Phase I oncology trials, one of the few subsets of Phase I trials in which the patients already have the condition, patients often need treatment urgently and are loath to wait for the time-consuming processes of SDV and correcting duplication to be completed.
Not all of these costs would be directly mitigated by eSource. But if eSource can save time and money in some areas of clinical research, then costs associated with other areas become less burdensome. Due to increases in the complexity of diseases and regulations3, clinical trial costs are rising, as is pressure to fast-track research and drug approval; in this environment, the industry is ripe for a tool to enhance efficiency in the fundamental processes of clinical trials. While there are indications that a sizeable portion of sponsors and CROs currently use eSource, the technology has yet to completely take off. When it does, though, we may be looking at a breakthrough in efforts to simplify the often costly and time-consuming bureaucracy of clinical research.
1 Majority of Clinical Trial Protocols Are Amended, But One-Third of Those Changes Are Avoidable; Tufts Center for the Study of Drug Development; 13 September 2011
2 Ilancheran, Mathini; Understanding Key Early Phase Clinical Trial Cost Drivers; Clinical Leader; 19 May 2015
3 Jadhav, Sujay; Disruptive Technologies: Breaking Down Barriers to Drug Development; Applied Clinical Trials; 20 May 2016