We're One But We're Not The Same : IRT for all clinical trials

"We're one but we're not the same", the refrain from the classic U2 song 'One', is a good way to describe the IRT (interactive response technology) needs of clinical trials. While many elements may be common across all types of study or groups of studies run by the same sponsor/CRO, or within the same therapeutic area, trials can have unique requirements for randomization and trial supply management (RTSM) that are specific to the study protocol. Typical transactions like 'Record Patient Visit' or 'Confirm Medication Shipment' may be common, but randomization algorithms and resupply methods may need to be different.

Clinical trial phases are one area where there are key differences to consider in designing, or selecting a provider, for your IRT service:

Early Phase

Early phase (I/IIa) studies require systems and processes that are fast, flexible, and cost-effective while coping with complex study designs. The challenges of safety focused studies include:

• Set-up time required can be very fast with timelines often determined only by availability of the IRB (Institutional Review Board) to review protocols              
• Studies often need very rapid design changes as information is learned about a new drug candidate, new formulations become available and dose ranges are established              
• Extending trials to multiple sites to increase patient recruitment makes potentially complex cohort management and supplies tracking more difficult and risky to manage manually
• Relatively small study budgets for technology

Phase II/III

Phase II/III studies can have the greatest combination of complexity of protocol and size. The challenges of Phase IIb and Phase IIIa studies include:

• Complex study designs
• Large numbers of global sites and patients
• Managing limited, expensive clinical supplies

Peri/Post-Approval

Late phase (IIIb/IV) studies, otherwise known as peri-approval and post-marketing studies, require operations and technology that can support large global study sizes. The challenges of peri/post-approval studies include:

• Increasing size (up to 100’s of sites and 10,000’s of patients) and data complexity
• Site personnel may have limited clinical trials experience
• Global studies introduce language barriers - sites are often not English-speaking
• Sites can have limited storage for supplies
• Maximizing compliance in patient reported outcomes

Other discriminating factors

Company standards, geographic regions and therapy type (drug, device or combination) also bring with them additional requirements for the IRT / RTSM service.

How to maximize standardization while meeting unique study requirements

Standardization in IRT systems is desirable. Sponsors/CROs want to use common terminology across their studies (i.e. 'patient' or 'subject'); make user interfaces and functionality familiar to use for their sites; and simplify system builds by not completely re-inventing the wheel on every trial. The ultimate aim is to reduce timelines and costs for delivering and operating the IRT service for each study.

So how can you balance a drive towards greater standardization with the need to incorporate protocol-specific variations?

With a configuration-driven approach to IRT system delivery, standard parameters and workflows can be configured once, and then loaded into each new system for individual studies. Study-specific requirements can then be implemented by adding/changing parameters, or if necessary by plugging in custom software modules. This approach offers the benefits of easily maintaining standards across studies, while providing the flexibility to adapt to unique trial needs. Because most of the work is done through configuration and not software programming, it can be done more rapidly, cutting weeks off of the historical system implementation timelines. And the sponsor/CRO can see the results of the changing configuration immediately, and easily and quickly give feedback to the service provider.

With modern interactive response technology and an experienced service provider you should expect a better way to maximize standardization while meeting unique study needs, and an easier build and operational experience. The IRT service on your studies can be both similar and not the same.