How to do a reevaluation (Power User)

Table of contents

• Step 1 : Creating a new trial stage
• Step 2 : Creating (or duplicating) a plan with up-to-date assumptions
• Step 3 : Importing and matching an IRT data extract
• Step 4 : Generating an initial state setup and reevaluating assumptions with trial actuals
• Step 5 : Running simulations

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Thanks to the advanced capabilities of the N-SIDE Supply App, updating critical clinical supply decisions for an on-going trial facing unexpected events has never been so intuitive!

To reevaluate a trial with the N-SIDE Supply App, users follow an easy 4-steps process:

1. Creating a new trial stage

2. Creating (or duplicating) a plan with up-to-date assumptions

3. Importing and matching an IRT data extract

4. Reevaluating the plan and generating the initial state setup

5. Running simulations

Step 1: Creating a new trial stage

Performing a reevaluation of an on-going trial must be done in a new trial stage. To create one, see How to create a new stage.  

Step 2: Creating (or duplicating) a plan with up-to-date assumptions

In the newly created stage, you will first need to build an updated simulations model derived from the one you had created when building the initial stage, in order for it to reflect any new information or assumptions relevant to your trial (e.g. new recruitment timelines, shifted production schedule, etc). To this end, in each setup category, click on Copy from another stage to import the setups from the initial stage into the new stage: 

 

Then proceed to update the setups according to all new relevant information you will need to factor in.

Once all the necessary changes have been made, assemble these setups by creating a plan.

You can also duplicate a plan and move it to a new stage. The “Duplicate in a new stage” action can be found at the plan level (see screenshot below). This action creates a new stage and retrieves the selected plan in this new stage directly. All setups used in the initial plan are automatically copied in the new stage.

When duplicating the plan in the new stage, the stage name/description and the plan name/description are editable (see screenshot below).

You can decide to share this plan or not with the trial team via the corresponding toggle button (see screenshot below). When confirming the duplication, you have the choice between closing the modal and remaining on the current plan or being redirected to the duplicated plan, in the new stage.

 

Step 3: Importing and matching an IRT data extract

A key benefit of performing a trial reevaluation is to leverage “fresh” trial data – or “trial actuals” – in order to further refine the setups and get the most accurate forecasts from simulations. To do so, you will need to import the latest available IRT data extract into the new stage, which can be done either by means of an IRT connection, or manually.

With an IRT connection, the import of IRT data extracts into a trial stage is automated and occurs at a desired frequency (e.g. daily or weekly import). However, the “target stage” of the IRT connection will have to be changed manually to correspond to the new stage in order for the IRT data extract to be updated accordingly. An IRT connection is set-up by the person with IRT Connection Manager user role in your organization.

If no automatic connection is setup, to import an IRT data extract manually, from the trial stage you want to import the extract in, go to the IRT data extracts section, click Import extract and follow the indicated steps:

 

To allow for a seamless integration of trial data into your simulations model, you will also need to perform/check the matching of the IRT data to the trial master data. This is done in the Matching section of the trial, in which you have to associate IRT data extract references to trial master data parameters such as package type names, lot numbers, locations, etc.

Sometimes you may need to edit trial master data information to be able to match all entries. For example, you will need to add new lot numbers present in the IRT data extract to the Trial Master Data if these are not included yet. Note that only users with the Power user role have permission to edit trial master data information.

Step 4: Generating an initial state setup and reevaluating assumptions with trial actuals

Now that the latest IRT data extract has been matched, you will reevaluate the plan created in step 2 in order to:

• Generate an initial state setup, which is a snapshot of the current state of the trial at a fixed point in time (number of patients enrolled and latest status of their treatment, current inventories at sites and depots, etc).

• Reevaluate key clinical assumptions based on trial observations, e.g. recruitment, titration and drop-out probabilities, screening failure rate, etc, taking into account the number of observations available and level of confidence in assumptions.

To do this, on the plan that you have created in step 2, click Create Initial State & Reevaluate:

 

A pop-up window will open. As a first step, make sure that the correct IRT data extract is selected, then click Create Initial State:

 

 

Within a few seconds, the initial state setup will be created and will appear under Available setups. If multiple initial state setups are available, make sure that the recently created one is selected and click Next to confirm that you will use this initial state setup in your plan:

 

You will now have the possibility to reevaluate assumptions from two setups of your plan: the Recruitment setup and the Treatment setup. For each assumption reevaluated, you must also define the level of confidence you want to give to initial assumptions, which will affect the output value of the reevaluated parameter (e.g. if global drop-out was assumed to be 15%, and observed drop-out is 20%, then reevaluated drop-out will be closer to 20% with low confidence level than with a high confidence level).

In the Recruitment and Treatment tabs, expand the Setup reevaluation menu to show the parameters to reevaluate, if you have a high (mainly the entered data will be used) or low (mainly the actuals will be used) confidence in the initial assumptions change the default Medium Confidence value then click Reevaluate. After a few seconds, the reevaluated setup will be available and displayed under Available setups. Once you have visualized the impact of the reevaluation on the assumptions using the graphs to the right, make sure that you deselect the non-reevaluated setup, then click Next.

 

 Recruitment setup reevaluation

 

 

Treatment setup reevaluation

 

Once you have reevaluated all the parameters that you wanted, a summary of the changes (initial state setup and reevaluated setups) will be displayed. Click Confirm Changes to save the reevaluated plan, which will be created from the non-reevaluated plan and now appear in the Plans section of the trial phase.

Step 5: Running simulations

Now that the reevaluated plan has been created, all that is left to do is run simulations to get results and identify the important clinical supply decisions to take.

Running a reevaluated plan is done in the same exact way as running a non-reevaluated plan: from the plans section, click View Details in the reevaluated plan panel, then click Launch simulation.

 

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