Reimagining IRT – Your Questions Answered

In our recent webinar ‘Reimagining IRT/RTSM’ Ash Patel, Associate Director, Project and Program Management shared how a future-proof IRT design can improve ease, speed and create a better experience for you and your sites.

To watch the full webinar click here.

Below we’ve highlighted the key takeaways for you and provided answers to all of the questions asked during the live session.

Key Takeaways and Q&A

• Ease and speed of set-up with pre-validated libraries and early demos access.
• Ease of use for your sites with in-built guidance and validation.
• Flexible study management with self-service tools and adaptable settings.
• Full visibility with on-demand reporting from high-level status dashboards to detailed data change history.
• Engage the experts early.

Questions

1. How are integrations handled?
   1. At Perceptive, we have a specialist integration team who will work with your data managers and the other vendors to create the integrations between the systems. It’s really important to align the timing of the vendors, for example, the EDC and IRT go hand in hand, one design informs the other. If they are built out of alignment there are challenges with amendments needing to be made. Good communication between vendors, clear timelines and milestones for all is crucial.
2. Can templates be aligned with therapeutic areas?
   1. The short answer is yes. We approach building templates in layers. Initially we build a generic template for a client at sponsor level, and we use that to create other variants. That generic client template will include terminology preferences, functionality that you would typically see, notifications you would typically expect to see and user group set up – so the roles you would normally see in your trial. All of that would go onto your more generic template. Once we’re happy with the client specific one we can copy that to create a therapeutic area version. Using Oncology as an example we can create an oncology specific template that has all client info on there but now it’s been made oncology specific. Perhaps you use the same common comparators throughout all your oncology studies, we can build that into the template and then validate it. When it comes to creating new studies from the template, knowing it’s starting from a validated system we then would start a study, copy the pre-validated client specific template and then build in the study specifics to that newly created study. For example, for this study you might not be using the comparators so you would remove it, or you might add another. This allows us to focus on what’s changed between the template and the study and that reduces effort and time.
3. How are you able to deliver demos on day one?
   1. Starting from a template allows us within a few clicks to create a new study, which has the basis of your clients oncology study. It won’t be the finished study on day one, but it allows us to have a visual of the system on day one which helps to drive that requirements discussion.
4. Can you tell me more about the consignment preview that you mentioned?
   1. Depot closures is a great example for this feature. If you know a depot won’t be able to resupply during a period of time (the holiday season for example) this feature allows you to pick a date in the future and run the resupply algorithm between now and that date. In a normal scenario there would be algorithm runs daily, and that would ensure automatic resupply of sites, but if we know there is going to be an extended period and we want to plan ahead for that, this allows you to go as far ahead in the future as you need. So you run it for an extended period of time and visually on screen it will tell you how much medication will be used by the participants that are expected to take visits during that time, it’ll tell you how much medication you currently have at site as well as how much the system thinks you’ll need to send to site. You can then at the click of a button raise the order for that medication to the site, if you want to.
      Another useful feature is if people are sending too much or too little IMP we can allow you to make changes to your resupply strategies. For example, if you want to increase your buffer levels or change a DnD offer and want to see how this would affect your supply chains, you can make those changes and run a preview of that strategy against the site and see what the system thinks should be included in the order and if you’re happy with that you can apply those changes to your sites.
5. Are there any concerns with highly configurable systems to meet protocol specific needs?
   1. What we do is learn from the past and present. From our existing programable systems, we’ve looked at all the features that have been requested commonly, the things that are custom and fully programmed, we’ve tried to ensure our highly configurable system has those from the outset. You’re right you can’t have a configuration for everything in a system. Our approach to this, with a cloud-based architecture we’ve kept this scalability in mind. The system is built with modular functionality. Essentially all these features are isolated, independent blocks of functionality. Imagine each feature is a Lego brick and if we add or remove a piece from a model it may change the look and feel but the whole model doesn’t fall apart, and that’s true for the approach we take to adding new features to the system. With the modular approach we can add new features to the system in a fast and futureproof way.
6. Do you have any advice on supporting multiple versions of protocols as not all countries will approve a protocol at the same time?
   1. We would typically build PA approvals into the IRT – For example, a PA may introduce a new dose/stratification, which we would amend the IRT design to accommodate. We would then add controls at the study, country and site level to approve a site/country for a protocol – that allows a study or country manager to approve the IRT to use the new functionality as and when PA approval is received.
7. What are major common issues usually you come across during conduct phase?
   1. Each live study user role may have different common issues related to their tasks. The perceptive IRT team for each trial has dedicated contacts to support different aspects of the live clinical trial. During live study issues, the Perceptive project manager will gain further support from those wider team members that may not be always visible to the sponsor team. A few common cases where this will be an advantage can be:
      1. If there will be more than one batch of medication for a trial, then the switch over from one batch to another can be an critical time point. Adjustment of IRT expiry settings may be needed to accommodate a delay in a new batch, or further use of the expiring batch to optimise use.
      2. Potential protocol amendments. The Perceptive team are happy to engage early on any potential changes to discuss the impact, provide feedback and plan for a timely change over to a new protocol amendment.
      3. Site user errors. Perceptive has its own in-house helpdesk that has access to the IRT system and data tables. Perceptive may be contacted during the trial by the site to highlight that they entered incorrect information. This may impact a randomization visit, scheduled dispensing or any transaction available. How the data is amended may require discussion and collaboration to understand the best way to update the data to ensure the study goals are not affected. The possible options (with associated impact assessment) are provided by the Perceptive team at these important time points, when a situation doesn’t follow a standard ‘permitted adjustment’ case for the site and sponsor. The ability to make these live study changes has been invaluable to our sponsors on occasion, ensuring the best possible trial results are obtained with the least impact on participants.
8. How does a prediction strategy calculate supplies?
   1. The prediction system is a very clever part of the shipment generation algorithm. It is used when there are resupply visits that have a predictable dispensing element. The IRT system can access the visit schedule for each actively on-going participant within a site and assess what medication they may need for their future visits within the short and long prediction windows set up for that location. Any shortfall seen within the short window will initiate a shipment and the resulting shipment will include medication to cover the anticipated participant visits within the long prediction window. Prediction stock is in addition to trigger and resupply stocks at a site. So the prediction process inflates the site stocks in anticipation of upcoming visits to avoid site stock out. After recruitment closes it can allow stock levels to be fully optimized on site for the remaining visits.
9. Please can I know how to design IRT when the protocol changes in the middle of the study, after randomization visit?
   1. We would typically build new functionally into the IRT, but have approvals to allow the new functionality to be used at a site/participant level. For example, if the PA was to add additional visits or introduce a new dose, we would amend the IRT design to accommodate those changes, but with self-service controls to allow sites to use the new functionality once the protocol was approved at their site. This ensures sites that follow the original protocol are unaffected by the changes, and sites that are approved for the new PA are able to use the new functionality.