By Sylvain Berthelot, Solutions Consultant, Parexel Informatics
COVID-19 pandemic has seen the emergence of fast-paced study start-up, with the goal to bring a treatment to market as quickly as possible. These trials are either leveraging existing drugs that could be used to treat the symptoms, or new vaccines aiming to prevent further infections.
When these trials require an IRT system to manage treatment randomization, medication supplies and dispensing, study teams expect expedited IRT setup timelines, reducing them from weeks to days. As all trial setup activities are expedited, the IRT needs to be flexible to adapt to updates to the protocol during start-up or whilst patient recruitment is on-going and may require adaptation to the randomization during the study based on initial results.
The IRT is the system of truth when it comes to allocating patients to treatment groups and ensuring patients are dispensed the right treatment at the right time, especially in double-blind trials. Considering the risks linked to IRT, sponsors rely on the IRT team’s strength and expertise to meet these fast-paced studies requirements and deliver quickly, with flexibility and quality.
The complexity of an IRT design depends on the supply chain structure, the randomization schedule, the dosing management and the patient dispensing schedule. Vaccine trials are simpler in many aspects, as patients usually have one or two dispensing visits with pre-defined dose levels. Therefore, vaccine trials tend to meet fast-paced requirements better. More complex trials are still eligible for expedited IRT setup, but they may require more agility from the IRT team to adapt to the trial needs.
I consider the following points as being crucial to ensure a fast IRT delivery of good quality:
- Configurability: it is important to be able to use pre-validated functionalities and parameters that can be turned on or off by the click of a button.
- Prototyping: this is a good way to increase efficiency during the IRT specification and reduce the effort in user acceptance testing. When the IRT team can show the system and make real-time adaptation to the configuration during design meetings, the trial team has an immediate understanding of the end product.
- Focus: study teams need to be ready to dedicate the right amount of time to IRT discussions to make sure they thoroughly go through all the protocol requirements in sufficient details.
- Expertise: fast-paced trial setup requires quick decision making and study teams will heavily rely on the IRT team’s expertise to make recommendations on the system design. The right IRT design will achieve randomization balance, be able to assign the right treatment to the patient at all times and reduce cost of shipments and drug wastage to the minimum; expert input is important to all these aspects.
- Make concessions: study teams should also be prepared to adapt to the way the IRT system works as standard, as fast-paced start-up will leave no room for preferential and non-critical requirements that usually increase the setup timelines.
All these points are very important for the IRT system design phase. It is also important to think about how the trial will be supported during study run; fast-paced start-up means that there is less time for safe-proofing trial scenarios, and the study team may rely on the IRT team more, to adapt to the unexpected during trial run.
An unprecedented situation like the COVID-19 pandemic requires an exceptional response. IRT systems, like other key data sources in clinical trials, need to raise to the challenge. All the points above will be successful only with the right IRT team, ready to start within hours and to keep the pace up for the few days allocated to system setup.
Parexel IRT teams have already released 8 COVID-19 trials, including 4 that were delivered in less than 2 weeks from kick-off to first patient in. Our success in delivering quickly relies on our teams’ expertise and focus, expediting the specification process within hours, turning a prototype into a finished product within days, and working across time zones to release the system while the study team is asleep.
We are proud of helping sponsors bring treatment to patients suffering from the COVID-19 pandemic, delivering expedited IRT systems with focus, with quality, with heart.