Analysis of trends within Clinical Trials shows an exponential growth in study registrations over the past decade. The FDA (Food and Drug Administration) declared an average of 3900 trial registrations per year from 2000 to 2005 compared to an average of 18000 registrations per year from 2006 to 2015 (source: www.ClinicalTrials.gov). This tremendous growth is inexorably led by an increasing number of patients and participating sites, increasing the amount of generated data and the complexity to manage such a high number of trials.
Clinical Trial results are driven by the billions of data generated and the need to find smart solutions and processes to improve patient management, data registration, logistics and compliance is unavoidable. One of the key success factors of a trial is to ensure patients are randomly allocated to treatment groups (to avoid statistical bias) and comply to study treatment as defined in study protocol. All of this should in most cases be achieved while keeping the study blind.
How can clinical operations take up this challenge in an efficient and cost-effective manner?
If you ask them, I am convinced your Clinical Operations teams would be delighted to utilize an I.R.T. (Interactive Response Technology) system to help them in this difficult task. The IRT system is a central piece of trial management that enables patient randomization, real-time drug allocation, and dynamic drug supply forecasting.
The IRT for patient randomization
Randomization is the random assignment of patients to a treatment group based on different factors or not. This is the IRT's heart. Without randomization the system would lose many of its features and ability to facilitate drug allocation and supply in a blinded trial. Most evolved IRT systems can nowadays support most complex randomization techniques, such as Static Randomization, Covariate Adaptive Randomization and Responsive Adaptive Randomization. This automated and computerized process enables organizations to get rid of the old fashioned and fusty randomization by packaging which was leading to a great waste of medication and less robust blinding.
The IRT for real-time drug allocation
Treating patients on time, every time, with the right drug while keeping the study blind is not an easy task without help of an IRT system. Drug allocation via IRT is a good example of showing how necessary it is to use an interactive system. At randomization the IRT registers what is patient's treatment group and thanks to the preliminary programming/configuration phase the system can refer to a visit plan and look at the expected material type for next dispensing. Accordingly, the IRT will provide study personnel what kit number should be dispensed to each subject. The IRT can also be used to provide additional instructions to help the dispensing and mitigate the risk of errors. This real-time drug allocation based on a secured available stock at site and without pre-requisite interactions with clinical team streamlines the patient's treatment process and also reduces visit time.
The IRT for more accurate drug supply
Remember, the ultimate goal of sponsors is to see their drugs reaching markets. For this to happen they are looking to establish long-term relationships with centers (hospitals, clinics...) and retain their trust for conducting clinical trials. Nothing is more frustrating for investigators than not having the drug at site available for dispensing at time of patient's visit. This type of issue is deteriorating established trust and puts patient compliance and retention at risk. A robust supply chain is a must to ensure stock availability and intelligent forecasting tools are required to cut down cost of oversupply. The industry suffers from a lack of drug supply forecasting expertise and to alleviate risk of running out of stock sponsors tend to overproduce and over supply depots and centers.This overage represents a huge cost in phase III trials (for example) where a numerous number of sites across the globe are participating. The reduction of the overage with the help of IRT will largely balance the cost of building an IRT system. Indeed the nature of IRT (knowing patient's treatment group and expected future dispensing) makes it the perfect man to integrate an advanced supply algorithm (allowing removing expiry date from labels, medication pooling, just-in-time packaging etc). IRT providers are also offering supply expertise and consulting thanks to their exposure to large amount of trials of different phases and indications as well as their repetitive collaborations with sponsor's drug supply departments.
Estimated average effort for clinical teams to support IRT setup (specifications discussion and User Acceptance Testing) is approximately 15 hours plus an additional two hours per week when study is running (supervision and clarification required on daily IRT related activities). This time spent will overbalance the huge reduction of efforts needed to manage randomization issues, organize manual drug supply, keep the study blind, ensure patient compliance and safety etc. Mostly large trials are currently benefiting from IRT systems as the effort to cost ratio is obvious. Thanks to the improvement of IRT systems, which can now support complex phase I trial designs, there is a trend to include IRT into smaller trial as well.