CLINICAL TRIAL MANAGEMENT: ENABLING OPERATIONAL EFFICIENCY
The way the biopharmaceutical industry conducts clinical trials is undergoing a remarkable transformation. Coupled with this much needed evolution are new challenges specific to the increasing role that information technology will play to enable the new clinical development landscape. Of the many challenges facing the biopharmaceutical industry today, the critical need for greater operational efficiency in clinical drug development is paramount. With flat and even declining productivity, rising research and development (R&D) costs, more complex preapproval trials and large post-approval studies driven by the shift toward biological agents, and increasing regulatory demands, it is essential that clinical trials are managed more effectively and efficiently. While progress has been made in addressing these challenges, companies are increasingly turning to clinical trial management systems (CTMS) to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants.
The Globalization of Clinical Trials
The global clinical trial, while not new to either sponsors or clinical research organizations (CROs), is becoming more prevalent, Clinical trials are increasing in size and complexity and more global trials are being conducted with sites across diverse geographical regions. The predicted trend is that there will be a significant shift from North America/Western Europe to the Asia-Pacific region (APAC). Between 2008 and 2010 the percentage of trials conducted in North America / Western Europe is expected to fall from 55 to 38%. Clinical trials conducted in APAC countries offer potential cost savings as well as large patient populations, particularly of treatment-naïve patients. This shift will also have certain implications. Sponsors and CROs will need to support all operational aspects of global trials: languages, logistics, access control, regional requirements, and region-specific business processes. Furthermore, it will be necessary to understand and need local regulatory requirements. To manage global trials more efficiency, many companies turn to commercial CTMS. These CTMS are typically implemented as enterprise applications. A fundamental value proposition of an enterprise CTMS is the provision of a centralized trial repository, which enables standard trial management processes across the enterprise and provides end-users, who increasingly are more geographically diverse, with real-time data visibility into study progress. However, this does not necessarily mean that everybody who is involved in a study should have access to all information about it. Organizations should balance the need to empower their employees with access to available information against keeping tight control over data access, allowing only those with proper authorization into the appropriate files. Fortunately, technology solutions exist that provide the access control necessary for the clinical trial industry, as well as tools that significantly reduce the administrative overhead. The globalization of clinical trials needs to be truly worldwide rather than just a process of more trials conducted in different locations. This will require global unified systems with built-in functionality that support specific regional needs. The current mindset, however, is still more or less focused toward the traditional North America/Western Europe requirements and supporting prevailing business needs. For a truly global system, this view needs to change to ensure individuals and departments have an understanding of where they fit into the business process. Regional units need to understand how their work affects others in the process so that effective collaboration can take place. It is also important to assess the impact or implication that local infrastructure and culture might have on conducting clinical trials in developing countries. Understanding the local environment and requirements often drives innovation that brings about substantial impact. Innovative solutions that are very site-focused, very pragmatic, and very specific to the local infrastructure may overcome barriers. For example, patient follow-up is a significant issue in China. A large Chinese CRO has proposed utilizing mobile technology, in the form of cell phones, as a component of its site management system. The proposed system would allow stakeholders to send the alerts or messages via SMS, or push reminders to patients regarding visits. This form of collaborative tool, along with better data visibility, will help clinical research associates (CRAs) better manage their sites and increase study compliance.
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