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International Clinical Trials

Rapid Response

As the popularity of net interfaces in the clinical trial domain grows, Charles Gasman at PharmaNet Development Group discusses the future of interactive response solutions

Interactive voice response systems (IVRS) used in clinical trials have evolved beyond the telephone to provide web-based randomisation, sophisticated drug supply monitoring, shipping logistics and valuable real-time study metrics. In the clinical trial domain, the term IVRS has given way to new acronyms such as interactive response technology (IRT), and randomisation and trial supply management (RTSM) as providers recognise IVRS implies a telephone-only interface. Today the majority of systems are available over the web; most providers advocate use of their web interfaces, and some no longer support a telephone interface at all.

Internet reliability and standards are making the web more viable for time-sensitive, critical trial functions, such as patient drug assignment that once relied exclusively on the IVRS telephone interface. Web interfaces, for what are considered traditional IVRS capabilities, are able to bring speed, context and greater study insight to the user experience. Additionally, improved visual context and insight for users means fewer calls to the help desk, which in turn reduces support costs.

EVOLVING PREVALIDATED CAPABILITIES

The demand for cost savings and efficiencies is driving technology providers to develop more sophisticated, prevalidated capabilities within their platforms. To meet the needs for a wide range of studies, IRT system providers must offer an extensive array of plug-in functions. These plug-in functions must allow extensive configuration options to be viable without custom programming.

As the number of configurable options increases, so will the need for tools and processes to ensure effective configuration management. Configuration wizards and tools that enable quality control inspections will become increasingly common. Some providers are starting to offer tools that allow business analysts to set up and deploy IRT configurations without programming. Such tools generally support configuring the randomisation and drug assignment models for a study from a user interface, thereby facilitating a basic randomisation scheme and a drug assignment solution. More advanced tools support setting up drug supply management and other components such as screening, screen failure, discontinue and emergency code break functions.

In addition to new tools to set up and configure studies, interactive response systems require tools for supporting data changes throughout the trial. Unlike the majority of data changes within electronic data capture (EDC) systems, data changes in an IRT are often made based on data points that will be acted upon by other IRT automated processes. Consequently, a data change within an IRT has the potential to impact the behaviour of downstream functions. For example, changing the kit numbers assigned at a visit because of damage to the original kits will cause the IRT to choose different kits for the next subject assignment, and may also dispatch a drug supply order to the depot. The bottom line is that the support specialists that work with this data will continue to require advanced data editing tools that minimise the risks inherent in making changes to actionable data.

INTEGRATION & eCLINICAL SUITES

Integration of IRT and EDC data has become increasingly common. The typical integration scenario involves a transfer of data from the IRT into the EDC upon completion of screening, randomisation and drug assignment transactions. This ensures that case report forms (CRFs) automatically get the information collected in the IRT. As the number of data points collected in an IRT are small compared to the EDC, and there are typically substantial edit checks used to ensure accuracy, transferring IRT data into the EDC system provides substantial benefits by reducing data discrepancies and queries.

Some providers have taken the approach of embedding traditional IRT capabilities directly within their EDC systems. The obvious advantage to sites is that they can perform EDC and IRT processes from a single web interface. However, there are potential drawbacks to this approach because of process differences and the real-time nature of IRT-related transactions. For example, in a combined EDC/IRT system, the site coordinator may be compelled to fill out the entire CRF for the randomisation visit, whereas in an IRT system the coordinator would only be prompted to fill out the information necessary to randomise the subjects to treatment. Such limitations can be addressed by devoting special attention in the CRF design to highlight the limited information necessary to complete the IRT transactions. Training and expert-level support on the IRT components of the EDC system are also essential to the success of such implementations. Finally, embedding IRT capabilities within an EDC raises service level agreement requirements to the necessary availability to support most real-time IRT functions.

FUTURE TRENDS

As the clinical trial industry evolves, interactive response solutions will need to evolve as well. Adaptive trial designs will certainly be a significant driver of change and innovation in interactive response systems. Adaptive trial designs often raise the complexity surrounding randomisation, drug assignment and supply management; therefore, interactive systems will become more essential to effective management of these trials. Additionally, interactive systems will need to support an ever increasing variety of configuration options to allow for multiple randomisation schemes within the same trial, which in turn will affect the dispensing of drugs at visits, as well as the drug supply management logic needed to satisfy visit consumption. As myriad configuration options appear within the system, technical interactive system specialists and IRT project managers will continue to play vital roles in supporting clinical trials, regardless of whether the solution is provided simply by an IRT, or embedded within an EDC.

The proliferation of smart phones, tablets and other network connected devices will also drive innovations in future interactive response systems. Many systems today enable collection of electronic diary data from patients, largely by using the telephone interface in the IRT. The boundaries between handheld electronic patient reported outcome (ePRO) vendor offerings and those supported within interactive response systems will continue to overlap and may ultimately disappear. Many IRT providers will add tablets and other smart devices to their list of supported interfaces. As these innovations emerge, study teams will think of the IRT as more of a multi-mode tool used to capture data, simplify logistics, and provide real-time ‘business intelligence’ into the conduct of clinical trials rather than just a randomisation tool.

The trend toward configurable solutions that require reduced custom programming will continue. Technology providers offering such systems will refine them to support a broader range of configurations, and will move towards enabling contract research organisations (CROs) and sponsor personnel to deploy and customise configurations on secure platforms.

Future IRT systems will utilise artificial intelligence techniques to self-adjust for optimal performance. By constantly analysing actual enrolment rates, screen failure rates, discontinue rates and visit schedules, IRT systems will increasingly apply this intelligence to self-adjust supply shipment business rules to further conserve supplies. These ‘auto-pilot’ features will increase the effectiveness of each solution while reducing the level of supply monitoring support.

As these trends mature, we will find that the clinical IRT marketplace will begin to follow the model of the current EDC and CTMS markets. The IRT market will likely be segmented into technology providers and service providers, with IRT technology providers that sell and support platforms, and CROs and sponsor teams that implement and support studies on one or more IRT platforms. Consolidation of technology providers is likely as they pursue a strategy to offer comprehensive eClinical suites. While study sponsors and CROs reap substantial benefits from technology platforms that offer far more capabilities, they will also face challenges in selecting and integrating platforms, as well as in managing and supporting complex configurations throughout each clinical trial.


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Charles Gasman is Executive Director, Interactive Technologies at PharmaNet Development Group. He has over 20 years of experience in technical project management, software development, testing and systems engineering. Since joining PharmaNet in 2002, Charles has driven product development initiatives that have resulted in second and third generation IVRS and IWRS technology solutions, and standard integrations across the company’s IVRS, EDC and CTMS product portfolio. Prior to PharmaNet, Charles held technical management positions at Lucent Bell Labs and ADC Telecommunications where he contributed to the successful creation and rollout of several advanced technology products and services in the areas of IVR speech recognition, high speed internet service provisioning and interactive television.
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