With the increasing complexity in protocols and need to increase the cost-effectiveness of studies, your IRT-related decisions play an even greater role in ensuring the most appropriate patient randomization and clinical supply strategies. Gone are the days of being able to use the "tried and true" IRT systems without further consideration of if they meet your protocol requirements. This is where an experienced IRT vendor becomes extremely helpful – one that is familiar with best practices, consists of experts in clinical trials and clinical supplies and with the skills and knowledge to manage complexity and anticipate issues. It's easy to predict what will go right but particularly challenging to know what might go wrong.
When reviewing a clinical protocol, an experienced IRT team will ask questions and identify issues that can have a significant impact on the IRT cost and effectiveness. The IRT team will:
- Seek clarification – For example, if the protocol specifies that there are 10 drug administrations, the number of IRT dispensing visits may or may not be 10 depending on how the study materials are packaged.
- Recommend ways to reduce complexity without affecting study conduct – For example, is there an easier way to determine each subject's lineage during multiple re-screenings without creating complicated subject number patterns that indicate the number of times a subject had been re-screened in each part of the study?
- Determine if the study will benefit from supplies forecasting – For example, are the materials expensive, stored and shipped cold with temperature monitors, hard to manufacture, have short expiry dates, etc.? Is it a global study with depots all over the world, will enrollment be staggered, etc.?
- Anticipate and plan for post-live protocol design changes and adaptive studies – For example, these changes could include adding or removing treatment arms, accounting for cohort dose levels that are not known until data from a previous cohort are reviewed, etc.
When designing the IRT system, an experienced IRT team will anticipate clinical and logical challenges and will recommend:
- Re-supply strategies to effectively use clinical supplies, such as predictive strategies and settings or pooling of materials at the study or campaign level (if applicable).
- Randomization strategies, such as standard, schedule-driven block randomization, or when a minimization algorithm can best meet the objectives for treatment group assignment.
- Kit numbering strategies (when asked), such as randomized instead of sequential kit numbers.
- Visit schedule and visit design strategies to accommodate visit skips, unplanned visits, dosing rules (titration and relative range) and the handling of visit exceptions, such as withdrawal visits when subjects need to be titrated down as well as the automatic discontinuation of subjects based on defined conditions.
While supporting and maintaining the live IRT system, an experienced IRT team will look for trends and provide solutions for unexpected situations (many of which can be anticipated prior to study start, in addition to pre-defined and pre-approved approaches), such as the following:
- Managing visit window hard stops, such as when they can be overridden.
- Managing kit substitutions and partial dispensing when sites do not have the needed material types and quantities in their available inventory.
- Using forced randomization when recruitment is difficult and sites lack the kit types needed for the next treatment group assignment.
At the same time, your IRT product should be able to support the most advanced randomization and supply capabilities, including adaptive solutions and minimization randomization (Pocock Simon), while minimizing interruptions as the study changes. The Trident IRT system is a robust and highly configurable system that can meet a wide range of study designs with little to no customization, including adaptive study designs. Bioclinica's IRT team has both domain and product experience that has been built into Trident IRT and is used to provide recommendations for protocol implementation based on industry best practices. We recommend and facilitate study designs that avoid unnecessary complexity by helping you achieve the best match between the protocol, your organization and our IRT product.