Technology planning, implementation, and management are critical concerns throughout the trial planning process. Including flexible randomization and trial supply management (RTSM) systems (also known as interactive response technology, or IRT) is also critical, since they may change treatments and randomization situations quickly with little or no downtime for systems, locations, or users. Because users may make numerous changes on their own, such as permission updates and alert choices, using a flexible RTSM solution helps decrease change orders.
There has never been a greater demand for adaptable and scalable RTSM systems as clinical studies become more sophisticated and expensive. The incidence of unexpected protocol revisions has increased, as has interest in and implementation of adaptive trial designs, which can enhance outcomes and efficacy with fewer trials while limiting patient risk.
Adaptive designs differ from traditional, fixed-sample designs in that they allow for valid and compliant preplanned mid-study changes.
Continue reading to learn about the need to utilize a contemporary RTSM system that is flexible, adaptable, and pre-validated to manage mid-study modifications for even the most complicated trials with minimum to no downtime and the potential to reduce the number of change orders.
RTSM Solutions Must Be Flexible to Handle the Increasing Frequency of Mid-Study Protocol Amendments
According to Ken Getz of the Tufts Center for the Study of Drug Development (CSDD), protocol revisions in clinical trials are on the rise. According to a report, between 2018 and 2020, approximately 59% of clinical trials had at least one modification, with rates of 78% and 69% for phase II and III studies, respectively. This growing tendency has been most noticeable in trials with more sophisticated designs, such as oncology, where phase II protocols had nearly double the average number of significant revisions as non-oncology protocols.
Additionally, phase II protocols for rare illnesses often require an average of 4.3 substantial changes, which is about 65% greater than the average for non-rare diseases. Protocols for rare illnesses generally include 3.8 substantial revisions in phase III, which is 19% more than the average for non-rare diseases.
A Multitude of Mid-Study Changes are Possible
Basket, umbrella, and platform trials are becoming more popular, with the unifying thread being that they all require a flexible RTSM system. As sponsors embrace more diversified designs, their RTSM systems must be capable of implementing complicated modifications, both intended (adaptive trial designs) and unplanned (protocol amendments), that frequently occur throughout the research, such as the following:
- Study design changes
Changes to the research design, such as the randomization procedure, eligibility criteria, trial length, outcomes, dose, data analysis techniques, treatment scenarios, dispensing restrictions, or sample size. This category also includes modifications to the investigational product utilized in the trial, such as changes to the dosage or administration method.
- Investigational product changes
Revisions to clinical supply packaging, labeling, quality assurance, and delivery, including the use of new drug depots. Site modifications include adding or eliminating clinical trial sites, updating the site monitoring strategy, and transitioning to/from direct-to-patient administration.
- Regulatory changes
Changes in regulatory criteria or rules that influence research conduct and/or data collecting, such as allowing qualified person (QP) release for newly onboarded areas.
- Changes in data management
Modifications to the data management strategy, including techniques for data collection, handling, and storage. To deal with the numerous mid-study adjustments, RTSM systems must be resilient, scalable, and adaptable. Octalsoft's RTSM provides smooth mid-study adjustments by offering the required flexibility and scalability while minimizing the expenses associated with change orders.
Next-Generation RTSM with Octalsoft
The RTSM from Octalsoft allows users to handle mid-study modifications to randomization and dispensation designs, as well as study visits, in a simple, rapid, and pre-validated way. Because users may make changes directly in the system for changes that do not need any configuration changes, there are fewer change orders and almost no downtime for sites or users.
When modifications are made in the middle of a live trial (for basic research designs), Octalsoft's RTSM produces a new distinct study design, to which sites can be allocated based on IRB permission. Based on country-specific clearances, the research team can even link sites to alternative design versions.
Octalsoft's RTSM also includes full version control and the ability to transfer designs from one environment to another for testing, allowing users to check modifications before deploying them in production. Mid-study adjustments in other research designs, such as cohort and dynamic allocation studies, generally need expert guidance and implementation.
Users may also make a variety of mid-study alterations in real-time. Once a modification is made, it may be implemented without disrupting patient site appointments or shutting down the entire system, ensuring that the trial's performance stays uninterrupted.
Octalsoft is a forward-thinking firm that is always proposing creative methods to improve our settings, like Octalsoft's RTSM, to better enable mid-study adjustments and set your research up for success.
Set up a Free Demo with one of Octalsoft's RTSM specialists now to see how the system may increase the flexibility of your clinical trials. We look forward to hearing from you. Watch this space for more information, updates and fresh insights for your clinical trials in Octalsoft’s vast library of scientifically driven publications written by our team and industry key opinion leaders.
