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Applied Clinical Trials
Overcoming clinical research inefficiencies to improve trial outcomes.
Before starting this article I did a quick search in Google for "clinical trial software." As expected, I was presented with a vast range of results that included eTMF, EDC, CTMS, RTSM, portals and statistical reporting software from a wide range of vendors.
Clearly, the modern clinical trial necessitates the use of many systems, from a variety of vendors who utilize different technologies and platforms that are nearly always incompatible. Key systems include EDC, CTMS, ePRO, RTSM, safety, and eTMF, but these are often just a part of the overall solutions map.
In the past, integration of these systems was at best difficult. Integration would typically be point to point, meaning that integration layers would be developed between each application. The result was an extensive integration process that was complex to implement and error prone. Organizations are now preparing for a more agile, distributed and federated model to address the increasingly pervasive nature of integration. Also, there is an increasing demand for data visualization and collaboration portal that serves as a "single source of truth" for the organization.
Single sign-on allows a user to log in once and access all the independent software systems. Gaining popularity within the pharma community is SAML (security assertion markup language), an XML-based, open standard data format for exchanging authentication and authorization data between systems. SAML provides a set of interoperable standard interfaces that allows for faster, less-expensive, and more reliable integration. The benefit for end users is quite simply the ease of accessing the variety of applications with a single user name and password while identity federation with SAML results in improved user experience while promoting privacy.
SOA (service-oriented architecture) is a set of principles and methodologies for architecture, design, and development of software applications to create interoperable services. SOA provides a set of architectural guidelines to build a flexible technical infrastructure to consume or publish interoperable services and web services.
The goal of SOA is to provide a global array of collaborative services, which are managed, published, and available for invocation on the unified service platform. Adopting SOA is essential to deliver a streamlined infrastructure to integrate and exchange essentials between software applications and the enterprise. While web services has its critics, it is a standard for exchange that all vendors can follow. By implementing web services, it has become far easier for different applications to "talk" with each other and, more importantly, for many different applications to consume the same service, eliminating the need to develop complex point-to-point integration.
CDISC describes itself as, "a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission, and archive of clinical research data and metadata." With a growing membership list, CDISC is really the only standard available for the exchange of clinical trial data. CDISC supports many standards including the operational data model (ODM), which has both import and export standards to facilitate the exchange of clinical data. These provide a system-agnostic method of transferring data and metadata between applications. The standards are also easily extendable so that application-specific standards can be created and maintained. As CDISC standards mature, they are now driving end-to-end efficiencies in clinical trials. The protocol representation model standard can be leveraged to transfer electronic content to EDC (i.e., CDASH), which can, in turn, be used to set up SDTM and ADaM datasets for analysis and submission. CDISC standards, therefore, not only support data transfers between systems, but end-to-end clinical trial standards and efficiencies.
Many pharma organizations are investing in clinical portals, including ones designed specifically for investigators. Clinical portals are designed to centralize access to all critical trial data and documentation for a single trial or across multiple trials. A well-designed investigator portal can significantly improve investigator satisfaction and facilitate collaboration between the investigator and the CRA.
Going beyond an investigator portal, a sponsor portal can remove the boundaries created by different departments. An eClinical portal can provide centralized access to critical clinical data from any source, including EDC, CTMS, ePRO, RTSM, regulatory, and safety systems. metrics, milestones, and KPIs from any system can be delivered directly to the user's dashboard, which is typically role based. Supporting single sign-on, portals provide immediate access to all clinical systems, which are able to support single sign-on standards such as SAML.
Clinical trials are going mobile. The widespread availability of tablets and smartphones coupled with the affordability and coverage of mobile Internet availability give a unique opportunity to provide global, immediate access to clinical trial data in the field. The increasing popularity of ePRO demonstrates quite clearly how mobile devices can be used to accurately collect data directly from the subject. But there is significant opportunity beyond ePRO for all stakeholders of a clinical trial to leverage mobile technology. Native and mobile web apps can be leveraged to create effective clinical applications such as site monitoring. Mobile web apps offer many advantages as they are easier to develop and deploy while a native app may be more suited to perform offline functions.
The increasing regulation, rising costs, number, and complexity of clinical trials are forcing sponsors to be creative in how they conduct clinical trials. Their goal is to comply with regulations while managing cost and increasing efficiency while improving trial outcomes. As a result, sponsors are turning to technology to gain competitive advantage. However, the bewildering number of clinical trials solutions is a burden in itself with every vendor supporting different technologies standards.
The latest technology advancements and the continuing evolving standards give a unique opportunity to provide an advanced eClinical ecosystem to achieve these goals. Collectively, the advent of web services, CDISC and SAML standards mean that, for the first time, a truly, fully integrated and single sign-on eClinical platform is achievable, whether it is from a single vendor or as a platform that integrates different vendor and internally developed solutions.
Simon Sparkes is Senior Vice President, Clinical and Compliance at ArisGlobal, e-mail: [email protected].