On January 9, 2026, FDA published draft guidance on using Bayesian methods to support primary inference in pivotal drug and biologic trials, covering INDs, NDAs and BLAs. It sets out three core expectations: success criteria defined by posterior probabilities, principled prior specification, and prospective evaluation of a design's operating characteristics before the trial starts.
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Day 28 is an Arm B only visit, so Arm A participants never see it.
Jan 9, 2026
FDA published its Bayesian methodology draft guidance
3
core expectations: posterior success criteria, principled priors, pre-specified operating characteristics
Mar 13, 2026
public comment deadline on the draft
0
statistical analysis Capture performs for you; that stays with your biostatistics team
The guidance
The guidance focuses on Bayesian methods used for primary inference in pivotal trials meant to support effectiveness and safety findings. FDA lays out three expectations it wants addressed up front, not worked out after the data comes in: how success is defined through posterior probabilities, how any borrowed prior information is justified and safeguarded, and how a design's operating characteristics, like type I error and power, are evaluated before the trial starts.
11
visits
9
draft forms
2
diaries
What the platform side needs
Set up arms, epochs and visit schedules that differ by arm, including added or dropped visits mid-study.
Amend the randomization list and allocation ratios yourself as an interim analysis calls for it.
Edit checks and auto-queries keep the dataset an interim analysis pulls from as clean as the final one.
Protocol and form amendments are tracked in the same audit trail as the clinical data, so a reviewer can see exactly what changed and when.
What Capture is not
To be direct about scope: Capture does not run Bayesian posterior calculations, define your priors, or simulate operating characteristics. That is your biostatistics team's work, done in dedicated statistical software. What Capture does is give that team clean, exportable data and a study build flexible enough to support whatever adaptive or Bayesian design they land on.
| SUBJ | ECGPERF_CODE | ECGPERF_LABEL |
|---|---|---|
| 01-001 | Y | Yes |
| 01-002 | ND | Not done |
Before you switch
Free sandbox to test a flexible arms/epochs build, no credit card required.
Field-level audit trail across every design amendment, not just the original protocol.
Amend the visit schedule and randomization list yourself, without a vendor change-order cycle.
Bring an existing adaptive design's CRFs across; the AI drafts a starting point from your protocol.
Email support, typically under 24 hours, plus documentation on Enterprise.
Free sandbox with every feature. No credit card, no sales call.
It set out draft expectations for using Bayesian methods in pivotal trials: posterior-probability success criteria, principled prior specification with safeguards, and pre-specified operating characteristics, published January 9, 2026 with comments closing March 13, 2026.
No. Capture does not perform posterior calculations, define priors, or simulate operating characteristics. That work belongs to your biostatistics team in their own statistical software.
Yes, on the data-capture and build side: flexible arms and epochs, amendable randomization, and audit-tracked amendments. The statistical design itself is separate, done by your biostatistics team.
No, it was a draft as of publication, with its comment period closed March 13, 2026. Confirm current status with FDA before relying on it for a filing decision.
Not necessarily. It needs a platform where the schedule, randomization and forms can be amended without a vendor change-order cycle, which Capture supports for any design.
Yes. The free sandbox includes every feature with sample data, no credit card required.
Keep exploring
FDA Operation Trialblazer guide
Another 2026 FDA evidence-standard change worth tracking.
ICH E6(R3) guide
The risk-based, flexible-design principles running alongside this guidance.
Protocol amendments without change orders
How mid-study design changes get tracked.
Clinical trial randomization software
The randomization tooling an adaptive design depends on.
EDC for rare disease clinical trials
Where small-N designs like this most often show up.
Free sandbox with every feature. No credit card, no sales call.