Applied Clinical Trials
In my last article, I spoke about the importance of the need for cultural change in clinical operations as a prerequisite to adopt innovation. This article will emphasize the areas in which clinical IT systems will change to support novel clinical trial initiatives, such as risk-based monitoring activities, and communicate clinical trial business data through IT system platform design, seamless data access & visualization advancements.
Where Do IT Systems Stand Today?
Figure 1 illustrates the changes in clinical IT systems over the past few decades. In the 1990s, clinical trial IT systems were in their infancy, as most clinical operations activities were handled through paper-based procedures. The most prominent IT capability in the early 1990s involved data analysis IT systems to determine statistical implication of subject data during NDA submissions. In the 2000’s, we started seeing IT systems that offered organized electronic capabilities, such as CDC, CTMS, and electronic drug distribution systems. While such systems allowed management to visualize clinical trial progress from a bigger picture perspective, the hope for improved operational productivity was crushed, as such IT systems exhibited unidirectional communication, were not easily integratable, and required significant amounts of manual data entry, which led to out of date data, data discrepancies across a variety of IT systems, and additional resources spent on manual data entry & notable cleanup efforts.
Figure 1: Changes in Clinical Trial IT over the past few Decades
Today, we are starting to see noteworthy enhancements in clinical IT systems. Today's clinical IT systems are moving into cloud-based solutions, and there are other capabilities that are assisting us with enhancing decision-making. For example, there are IT systems that specialize in customized visualization technologies, and offer innovative business insights that current IT systems do not currently employ. Additionally, we are starting to distinguish further database integration capabilities in clinical IT systems, however, data fields from varying clinical IT systems differ so vastly that it is difficult to yield seamless data sets. For example, SiteID in one system may be defined as Site_ID in another, and conflicts arise during IT system integration.
In order to address this issue, some IT system providers have adapted to this challenge by developing learning algorithms to automatically compare, identify and merge discrepancies from different databases. For example, these clinical IT systems are able to detect different data field patterns in separate databases (i.e. SubjectID vs Subject_ID), and automatically merge related datasets into advanced visualizations & reports without manual database manipulation. Such activities result in less time involving manual database integration, improved data quality, ameliorated productivity and cost savings, given existing technological limitations.
The Future of Clinical Trial IT:
The future of clinical IT is going to entail addressing the challenges associated with enhancing clinical trial productivity, saving costs and improving quality, and some IT suppliers are strongly headed in this direction. In IT systems, this means cutting down on manual data entry, seamless database integration, solutions that speed up clinical business operations, and visualization tools that enhance clinical trial quality. With more clinical trial study sites implementing EMR technologies, and a significant move towards cloud-based IT systems, we are going to see a one-stop shop for all clinical trial IT needs; one efficient system that study sites, CROs & Sponsors could all access unified communications.
Fortunately, some IT system suppliers have developed a solid, cloud-based & secure structure that includes a portfolio of different clinical trial IT aspects, such as CTMS, CDC, EDC, eTMF, drug distribution intractability & site activation key turn triggers, and is open towards continuous database integration. Future IT systems will allow for bidirectional communication, and may be able to integrate with EMR systems for seamless and real-time analytics, significantly cutting down on costs affiliated with manual data entry. Moreover, these systems would be paired with advanced data visualization platforms in order to assist management and clinical operations teams with exercising sound decisions.
Furthermore, we are seeing IT systems that are positioned for significant contributions towards enhancing clinical trial productivity and quality by auto population via integration. To demonstrate, site TMFs are stored in the cloud, are updated real-time, and fields within regulatory documents (i.e. 1572s, FDFs, etc.) will be pre-populated based on data received from the sponsor’s CTMS; sites will be able to sign regulatory documentation electronically, the quality of regulatory documentation will meet GCP/ICH standards, and the site startup process & study maintenance activities could improve significantly in both time and quality. Another description of such innovations includes subject visit & EDC integration; For instance, a sponsor could input subject visit fields in an electronic protocol template that integrates with (and automatically updates) EDC subject visits.
Future IT systems will also be able to assist clinical operations teams with supporting risk-based monitoring techniques, as such platforms will be able to communicate relevant, advanced and personalized visualizations to clinical operations groups.
What Can We Do Now to Better Position Ourselves for the Future?
As of now, it is difficult to assess the ROI of an IT system capability that is in its infancy. However, it is tactical to select IT system platforms that exhibit bidirectional communication capabilities, so that we could easily integrate and customize new IT solutions as future IT products unfold. Furthermore, due to the dynamics involved with clinical trials, it is important to train clinical operations staff on the basics of statistics, and analytical database mining & manual database integration capabilities.
When Will Such IT Systems Become Available?
While the concepts in article are much simpler than the actual activities encompassed in accomplishing the vision of enhanced clinical trial productivity & efficiency, the question will be answered with clinical IT providers who are currently taking risks to disrupt not only existing IT system suppliers, but also the way Sponsors think about IT system selection & implementation from business, financial & operational perspectives.