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Pharmaceutical sponsors conducting clinical trials in the Asia Pacific region have a rare opportunity at hand...
Pharmaceutical sponsors conducting clinical trials in the Asia Pacific (APAC) region have a rare opportunity at hand: by adopting Interactive Response Technology (IRT), they can automate one of the last bastions of manual record-keeping in clinical trials and realize upticks in productivity and data integrity.
Software platforms that integrate the processes and information related to randomization and delivering drugs to clinical trial participants have been in use in major drug development countries for well over a decade. They have, however, not yet been widely adopted in APAC where study managers, investigators, and supply chain managers often continue to manage randomization, track patients, and monitor inventory manually.
Meanwhile, the percentage of the world's clinical trials being conducted in APAC stood at 16% in 2013 and is destined to continue to climb.1 It only makes sense for study teams in the region to avail themselves of the same automation and efficiencies that their counterparts in other regions enjoy. Fortunately, users in APAC can “stand on the shoulders” of those in other regions and automatically reap the benefits of IRT functions and features. Here, we share advice, gleaned over the years and across thousands of trials, on how companies operating in APAC can design their IRT systems for maximum impact and efficiency.
So, what exactly is an IRT system, and what can it do? IRT systems, which were first introduced about 20 years ago, deliver a wide range of applications for managing patient interactions and drug supplies throughout the trial lifecycle. In serving sponsors, drug depots, and sites, they automate:
Basically, through functions designed for sites, study administrators, and supply chain managers, an IRT supports all of the activities and decisions involved in ensuring that sites have the supplies they need to successfully treat patients. (See Figure 1.)
Interactive Response Technology creates a virtuous cycle of information for coordinating all of the complex activities involved in distributing products to trial sites and the associated mitigating risks.
A well-designed technology platform will deliver efficiencies and performance insights, allowing sponsors to complete studies smoothly, on time, and on budget. IRTs commonly offer the following benefits to sponsors:
IRT systems can support virtually every type of clinical study, from the simplest to the most complex. The key is to follow a well-thought-out design based on input from all stakeholders within the sponsor company and its supply services partner. A fundamental goal should be to design the simplest system that can accommodate the study protocol and support the functional needs of the study team.
Companies that have not had any prior experience with an IRT system may want to consider beginning with a pilot, adopting a system for a relatively uncomplicated study before committing to using the technology more extensively.
The following steps serve as a best-practice approach to developing an IRT in the APAC region, where familiarity with the technology is still limited. When system development proceeds in this fashion, the resulting tool will suit the study, and development time and costs will be minimized.
An experienced development team can ensure that the recommended approach is compliant with all applicable regulatory mandates, such as the U.S. Food and Drug Administration’s, Title21, Code of Federal Regulations, Part 11.
The ultimate performance and usefulness of an IRT system can be assured through rigorous quality checks at four stages in the startup phase: when requirements are finalized, once the code is programmed, after testing is completed, and during the implementation process when the system is ready to go live.
Following the advice of others on “lessons learned” is a good way to avoid the pitfalls that can make adopting any new technology challenging. The following tips reflect the advice of specialists who’ve been involved in hundreds of IRT builds and implementations around the world. In general, newcomers to IRT should try to avoid:
Study teams that are considering using an IRT for the first time should perform due diligence into the qualifications and experience of their technology partners. For success in the APAC region, sponsors should assess vendors based on their:
Companies operating in APAC can look forward to a great leap in efficiency by adopting an IRT solution. Fortunately, the technology is well tested and has been applied successfully for years. Provided that sponsors work with a vendor experienced in supporting trials globally, their first experience with IRT systems is destined to be smooth, productive, and rewarding.
Matthew Do is Client Development Lead – Asia, Almac