Best practices: Technology in Late-Stage Trials

By: Kate Trainor
VP PACE Operations

Using Web-based platforms to improve late-phase clinical trials

Late-phase studies (such as Phases IIIb and IV, EAPs and observational studies) constitute a rapidly expanding segment of the clinical research environment.  Regulatory agencies around the world are requiring additional data about the long-term safety and side effects of new products when they are used by larger numbers of patients in real-world settings.  Healthcare providers – and those who pay for healthcare – are demanding clinical evidence that new therapies provide better outcomes or greater value than existing standards of care.  To meet those growing data requirements, biopharmaceutical companies need additional product and safety information that is not available from most Phase III trials.   

A typical late-phase study presents challenges beyond those experienced by researchers conducting earlier-stage trials.  One of the most significant differences between Phase I-III and Phase IIIb/IV trials is the need to enroll substantially larger numbers of patients for the late-phase studies.  While a Phase III trial might include as few as 1,500 patients and less than 100 sites, a Phase IV safety or marketing study could encompass 5,000 or more patients at hundreds of sites. 

Another major challenge is the fact that late-phase studies usually include a larger and more diverse range of physicians, including practicing physicians who may have little or no prior experience with clinical research or the protocols of gathering and reporting clinical data.  If a study calls for the recruitment of patients in multiple countries around the world – an increasingly common requirement in today’s global marketplace – sponsors face additional challenges involving regulatory, language and cultural differences that can impact both investigators and patients. 

Core eClinical technologies such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Randomization and Trial Supply Management (RTSM) systems are essential to support greater efficiency in logistics, recruitment, site operations and data gathering for late-phase trials.  Another eClinical technology – the web-based clinical portal – is revolutionizing the way site information is collected and processed, and automating study startup methodologies.  It is also improving the integration and exchange of late-phase clinical information by allowing authorized individuals anywhere in the world to share data such as trial milestones, study metrics, protocols and documentation – 24 hours a day.  Portals are particularly important for large global studies because they foster collaboration and communications between sponsors, sites and other parties that may be spread across hundreds of locations in dozens of countries and time zones.

Meeting the special requirements of late-phase studies

When considering eClinical technology choices for late-phase studies, sponsors and their outsourcing partners must balance multiple factors.  If the studies will be global in scope, some of the participating physicians and site staff may have little experience with EDC or other clinical technologies.  They may not speak English, so the technology must be able to support multiple languages.  The electronic tools also should be simple enough to accommodate people with a wide range of technological expertise, and should fit into the normal processes at the study sites.

A well-designed Web-based clinical portal gives sponsors and sites the ability to accommodate the unique characteristics of late-stage studies.  Although such web platforms still rely on other eClinical components such as EDC for basic data collection, they provide an easy-to-use, single “landing point” for investigators and other study personnel to successfully initiate, manage and close out studies – without the need to learn and access multiple eClinical systems.  This simplified access, intelligent system guidance, and centralized account management across the platform can significantly accelerate study start-up and implementation – especially for large studies that include significant numbers of research-naïve investigators.  

A clinical web platform serves as a consolidation point for key data from the various electronic systems used in a trial, providing a powerful tool for monitoring trial progress and comparing site performance.  It can also be used to efficiently lead investigators through streamlined processes such as e-Training and the submission of regulatory data.  In addition, portals serve as an efficient document repository and distribution system, allowing authorized users to access and share trial data such as study milestones, documentation and metrics – including vital data on patient safety.  Equally important, access to a web-based portal can provide an important incentive for site physicians involved in late-phase studies, giving them the ability to easily review study protocols, communicate with colleagues, and view payment information.  With the intense global competition for qualified investigators, clinical portals provide important benefits that increase investigator satisfaction.

Key requirements for an effective web-based clinical platform include:

• Ability to handle large numbers of sites and patients
• A simple user interface that provides a positive experience for research-naïve physicians
• Support for regional differences, such as language and regulatory requirements
• Fast start-up and cost-effective implementation across numerous sites and countries
• Strong support for data sharing among site physicians
• Ability to integrate data from underlying eClinical systems
• 24/7 technical support network and easily accessible on-line training and documentation

With the growing importance of late-phase studies, greater use of technology is essential to increase efficiency of data gathering and keep costs down.  Web-based portals will play an increasingly important role in meeting the demanding requirements of these large, global studies.