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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Sylvain Berthelot - Global Head, RTSM Solutions Consulting - 4.29.20 -
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:
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.
"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."
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