How to do a reevaluation (Advanced user)

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

To reevaluate a trial with the N-SIDE Supply App, users follow this simple process:

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

2. (Optional) Update lot management

3. Reevaluating the plan and generating the initial state setup

4. Running simulations

 

Step 1 : Creating (or duplicating) a plan with up-to-date assumptions

If it is the first reevaluation, you will first need to build an updated simulations model 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, proceed to update the setups according to all new relevant information you will need to factor in. You can do this by duplicating the previous setups and update the information in the newly created setup, so that you do not lose previous information:

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

From the second reevaluation, you can 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 2 : Update lot management (optional)

You can update the Lot management tab, e.g., rename some lots or add new ones. Once the lot information has been updated, you have to update the production and initial state setups.

Step 3 : Generating an initial state setup and reevaluating assumptions with trial actuals

You can now reevaluate the plan created in step 1 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 and screening failure rate, taking into account the number of observations available and the level of confidence in assumptions.

 

To do this, , click Create Initial State & Reevaluate on the plan that you created in step 1:

 

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 (low, medium or high). This level of confidence translates as the confidence in your assumptions you want to give to initial assumptions, which will affect the output value of the reevaluated parameter.

For example, low confidence output values will consequently be closer to observed values depending on the number of observations (past data) the system can draw from, 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 or low 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 stage.

Step 4 : 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.