Facilitating Data Management in Clinical Trials

The Internet and e-technologies have become an integral part of business in most sectors, but have taken time to gain traction in the clinical trials arena. As the industry faces challenges and further consolidation, companies are increasingly embracing technology as a lever to differentiate themselves, boost productivity, and succeed.



Dealing with Data In the pharmaceutical industry, the emergence and acceptance of Internet-enabled technologies such as Electronic Data Capture (EDC), have transformed clinical development practices - efficiently supporting faster, larger, and more complex trials.

Current industry projections estimate that the technology is now used in approximately 50 percent of all clinical trials. Companies are increasingly leveraging this technology and other tools to power global trials, and benefit from the ability to analyze incoming data and performance metrics in real time. The availability of such data supports more rapid decision-making and provides the agility to make the necessary adjustments during ongoing trials.

With the increased adoption of the technology, market expectations are high. A more technology-fluent user base is demanding richer features, ease of use, and flexibility within trial settings. Global usage also requires availability and scalability. Furthermore, there is a growing acknowledgement that this technology represents only a subset of the critical aspects of the overall data value chain, highlighting the need for a fully integrated e-clinical ecosystem. Such an integration of EDC and other eClinical systems will provide a holistic view across trials and data sources and minimize process and infrastructure redundancies.

Due to the increasingly prevalent use of EDC coupled with industry outsourcing trends, the role of an "in-house" data manager has changed considerably. Further removed from the daily discrepancy resolution routine, these individuals are now charged with program-level oversight responsibilities - including tracking the progress of work being conducted by third-party Contract Research Organizations (CROs), and sometimes across multiple organizations on several studies.

While skills in the core data management systems are still vital, better tools are necessary to provide oversight-level data in real time, and productivity and performance metrics are paramount to understanding and measuring this environment. While the ongoing global expansion of trials presents new opportunities, it increases the pressure and the demands that are placed on EDC and Information Technology (IT) infrastructure and support resources. The growing prevalence of global site users and outsourcing practices have transformed clinical trials into an around-the-clock operation.



No Time for Down-Time
This "always on" business model creates a technical support dilemma. Given the 24/7 availability requirements to support the global trial environment, there is no opportune time to schedule maintenance and perform repairs.

Furthermore, in the event that a technical problem that affects system availability does occur, all sites that are using the technology platform can potentially be affected. For example, a pharmaceutical company that is running 300 trials concurrently, might in the worst-case scenario, have to suspend workflow on all trials until access to the system can be restored.

Given the implications of this example, companies are focusing on issues such as infrastructure/server redundancy, backups, and failover. There is an absolute dependency on IT support and service levels to ensure business continuity in running clinical trials. This reality has been an internal hurdle for many organizations that are seeking to implement the system, and some have opted to outsource.

Similarly, since its use extends to site staff as well as CROs and business process outsourcing providers, the exponential growth of user populations has led many organizations to rethink their EDC support strategies. Both end-user training and ongoing helpdesk support are critical to success.

Vendors are moving into this space specifically to handle initial training, arrange Internet connectivity around the world, and negotiate Internet service provider agreements. They also provision and track hardware when necessary, and provide allhours helpdesk services in multiple languages.

Trials have evolved significantly over the past several years. Historically, the traditional trial model followed a natural, sequential pattern in which companies would collect data over the course of the trial. When the trial is completed, the database would be locked, to carry out analyses and assemble a candidate submission.

Clinical trials today, however, are more complex. The advent of EDC enables earlier data review, and it has also helped to advance new trial designs that rely on such early data availability. Instead of a single analysis after the trial is completed, trials today require multiple sophisticated data cuts and ongoing analyses. The availability of data from EDC helps to facilitate such "softlock" processes, effectively simulating a subset of the traditional end-of-study procedures with interim data.

This mid-study process can occur multiple times during the trial for safety monitoring boards, submissions, or interim reviews. However, utilizing this type of rolling lock system consumes more resources than the traditional process. So, while EDC enables resource savings for traditional discrepancy management activities (as projected), this trend for more complex trials and process changes, introduces added complexity and resource demands to support a study.

The use of adaptive trials is also increasing, which requires support for real time insights and a variety of mid-trial modifications for dynamic response to changing circumstances.

Complex trials are also being leveraged strategically to optimize resources and productivity given the constrained financial climate, budget cuts, and pressure to run fewer trial programs. To meet trial quotas while fulfilling project needs, companies can opt to run multiple studies within a single trial. For example, within a single oncology trial, there may be six separate study populations, each based on a different tumor type.



Data Integration and Interoperability
EDC is just one aspect of the eClinical ecosystem. There are many systems that are employed throughout the clinical development process for data acquisition, data analysis, trial management, and reporting. As the volume of data from all sources increases, the need for an intelligent aggregate data storage environment becomes imperative.

One such system - the Life Sciences Data Hub - enables access to all trial data from a single location. This reduces the time and effort that are required for study reporting milestones while providing the ability to accurately track and reconstruct complete reporting data sets and outputs.

While there are a multitude of available software platforms that are designed to manage various aspects of clinical trials, most of these disparate systems work independently of one another, unable to communicate or share information. Additionally, sponsor companies may use separate, independent vendors for each IT system, particularly if they seek to employ "best-ofbreed" options for every product type. When overlap does exist between applications but identical data must be entered into them independently, the issues of redundancy and inefficient use of both time and resources are compounded.

Going forward, interoperability will be a key factor in realizing maximum possible results using eClinical systems, allowing records to be linked and shared, and eventually improving efficiency and reducing overall costs. Industry standards will evolve to make disparate platforms interoperable and less proprietary. The Health Sciences Suite platform - a fully integrated suite of eClinical applications - is being developed that will also be able to extend to applications from other vendors.

The industry is changing rapidly and organizations across the pharmaceutical spectrum are dealing with many of these pressures, while trimming operating expenses, and establishing cost-effective and efficient working practices. The eClinical transformation offers an opportunity to maximize the value of clinical trials, improve pharmaceutical development efficiencies and ultimately provide patients with timely, new, and improved treatment options.

There will be short-term challenges to be overcome in the process of continuously adapting to new technologies and gaining acceptance of new ways of working. It is therefore critical to weigh technology investments against both short- and longterm objectives.