By James Rogers, co-founder and CEO, Nextrials, Inc.
With the fast pace of technological advancements, life science researchers are regularly presented with a wealth of new tools that can potentially bring life-saving drugs to market quickly and economically. One development that is generating a lot of industry buzz is the integration of platforms offering electronic data capture (EDC), traditionally used to manage clinical trials, with platforms used within the healthcare industry to create and maintain electronic health records (EHRs).
The federal government’s spotlight on EHRs, and the lucrative incentives it offers today through the 2009 HITECH Act to entice organizations to deploy them, have had a profound effect on both the healthcare and life sciences R&D industries. In healthcare, where most records have traditionally been “physical” media such as film (x-rays), paper (notes), or photographs, an EHR is now streamlining record storage and retrieval, easing billing issues, improving data input accuracy, and most importantly, increasing the quality of care for patients.
As the healthcare industry’s adoption of EHRs has widened, it has created a ripple effect in the life sciences industry, generating excitement among those who understand how EHRs might offer potential access to previously untapped patient population pools and significantly lower investigative study costs. Most researchers today are already using an electronic data collection (EDC) tool to help manage even earlystage clinical trials. Because the collection methodologies for EHRs are similar, could a single system simultaneously be used for patient care in both the hospital/clinic and clinical trial settings?
Data models to enable this type of integration are quickly evolving with support from industry groups on both sides. Some examples include the Integrating the Health Enterprise (IHE), Retrieve Form for Data Capture (RFD), and HL7’s Continuity of Care Document (CCD).
Eliminate Duplicate Data Entry And Workflow Issues
Outside of high profile, staged interoperability demonstrations, there has been significant progress in the deployment of integrated platforms since 2009. Nextrials and its partner, Greenway Medical Technologies Inc., conducted a multisite retrospective study in which patients were enrolled in real time, and patient data was collected through a single interface. The participating sites included facilities experienced in conducting research, as well as small medical clinics in their inaugural clinical trials. One of the outcomes of this pilot project was the successful resolution to two major problems long noted by industry leaders — duplicate data entry and workflow issues — that had been traditionally associated with disparate EDC and EHR systems.
With EDC/EHR platforms moving beyond the theoretical realm, why should life science drug discovery and development professionals care? What are the benefits? Here are five reasons to consider choosing an integrated EDC/EHR product for an upcoming study:
An integrated EDC/EHR platform can pre-identify sites with appropriate patients for even the most tightly focused study. This, in turn, fosters fewer enrollment delays — an important consideration from not just a cost standpoint but from the implementation requirements of a competitive, go-to-market strategy.
Research costs are considerably lower due to certain economies. For example, study monitors and research associates do not need to travel to sites as often for source data verification because 80% to 90% of the data is typically taken directly from the EHR.
There is a greater pool of potential sites, even those that have never participated in drug research, because the startup requirements are significantly lowered through an integrated EDC/EHR platform. The potential patient pool is also increased, as those living far from large medical centers can now enroll through smaller, more localized clinics.
By removing the potential for transcription errors, data quality is improved.
Information that isn’t normally collected within a site’s EHR can be collected on eCRFs (electronic case report forms) that are displayed in the EHR interface.
James Rogers is the co-founder and CEO of California-based Nextrials, Inc. With more than 25 years of life sciences experience, he is a frequent speaker at webinars and conferences. He can be reached at firstname.lastname@example.org.