A Randomization and Trial Supply Management system (RTSM) is partly a risk mitigation tool. It is used by trial teams, monitoring teams, and investigative sites to reduce some of the risks related to clinical trial execution, including:
- Risk of sites not having enough medication for patient visits
- Risk of sites dispensing the wrong kit to patients
- Risk of reaching recruitment targets without enough patients in some treatment arms, necessitating recruiting additional patients, extending study timelines, and delaying data analysis
- Risk of accidentally revealing a patient’s treatment arm, voiding the patient’s participation in the trial
Although a lot of those risks are inherently managed by the RTSM system, no two trials are the same. Trial-specific adaptations require in-depth risk analysis to reduce the chance of something unwanted happening during trial execution. The process of risk identification, assessment, and mitigation is one of the most important steps in the RTSM system setup phase, one that cannot be overlooked.
“You can measure an RTSM vendor’s experience based on how many potential risks they can mitigate.”
– Sylvain Berthelot, Sr. Director, Voice of Customer and Strategy, Calyx
Should risk analysis start from a blank piece of paper for each trial?
No, this would be a recipe for disaster. Starting the RTSM risk analysis from scratch every time would put too much reliance on the RTSM vendor’s team. They could easily miss trial risks that may not be obvious, which could lead to complications further down the line.
What the RTSM vendor should have is a list of potential risks that can be assessed by the system which the sponsor team can review to confirm if they apply to the trial. I always think that you can measure an RTSM vendor’s experience based on the length of the list of potential risks. This list will have been developed based on what the vendor has seen in previous trials. Hence, the more trials they have delivered, the more complete the list of potential risks.
Calyx IRT project teams follow a structured process when performing trial-specific risk analysis:
1. Review the list of pre-defined risks; for each risk, define the likelihood of it occurring and the severity of the impact on the trial.
2. Assess any risks that are driven directly by the trial design and environment that are not already in the pre-defined list.
3. For any risk that has a high likelihood/severity score, identify the most efficient mitigating actions. As an IRT vendor, our mitigating actions are mainly focus on reducing risks through system design. However, some mitigating actions may be owned by the study team as well.
4. Present the high risks and corresponding mitigating actions to the client team.
5. Track the completion of mitigating actions
This process is followed every time a change in the system and/or trial environment occurs, to control any impact on the IRT-related risks.
Why does expertise matter
IRT teams who have delivered RTSM systems time and time again know instinctively how to mitigate some of the trial-specific risks. Complex trials often lead to complex risks, and not all risks have been seen before. IRT experts will know how to tackle risks, even ones they have not seen before, as they know the RTSM system’s capabilities and they have access to in-house subject matter experts who will apply their knowledge to contribute to risk mitigation.
What about protocol amendments?
Changing a system during trial execution introduces new risks. You should have confidence in the experience of the IRT vendor, their established processes, and how they control change. You should also expect the vendor to review the risks logbook, refresh their risk analysis, and complete the mitigation cycle as necessary.
Risk analysis is an ongoing task, not a one-off.
