Release 2.0

Version 2.0 is a big release, bringing titration to Bluefin. This comes in two flavors: within-participant titration, and between-participant titration.

Within-Participant Titration

Use the new “titrate” option in a Dose Block to customize the Dose Levels and have participants transition between levels.

In a dose block, you can now turn on the “Titrate” switch to be presented with a new user interface. In the top-left, you can select create dose levels, and set how many participants initially enter each dose level.

A dose level setup where all participants initially enter Dose Level 1.

After setting up the dose levels, you can customize how participants transition between each dose level. Transitions will occur between repeats of the same dosing block.

Between the first and second repeats of this dosing block, 60% will up-titrate from dose level 1, and 5% will down-titrate from dose level 2.

Because this is all relative to the dosing block’s start day, it allows maximum flexibility in how titration can be used to forecast demand.

Between-Participant Titration

Between-participant titration is accomplished using “entry conditions” for cohorts. Participants will enter a cohort on one of two conditions:

• Randomly, using a ratio
• Using “entry from” or “entry until” dates, which signify when a cohort is open for enrollment

When cohorts have overlap in terms of dates, participants will be split between them using a ratio. Once placed in a cohort, participants are then assigned a treatment arm.

A two-cohort setup where participants entering the study enter into Cohort 2 after February 1st, 2025.

We can’t wait to see how our customers use these new features to build advanced dosing schedules within Bluefin.

Fixes

• Fixed an issue where the study selector on the sidebar would reset on page navigation.
• Fixed an issue where datetimes may be out-of-order on the reporting page.

API

The major version increment is also due to removal of old API routes that were deprecated in prior versions. The API is still the best way to use Bluefin programmatically and integrate it with other systems. For customers interested in bespoke integrations, reach out to us and we can discuss what options make the most sense.