Making Flare and Treatment Failure Reviews Easier to Follow

For a suspected flare or treatment failure, the site needs a clear list of the records required by the study. That might include the baseline disease assessment, the event assessment, relevant laboratory results, and medication dates. The protocol and adjudication charter should determine what belongs in the package.

 

I would also check what the instructions say about records that are not yet available. The site needs to know how to identify a pending result, whom to notify, and how to add it later. That avoids leaving staff to guess whether to submit an incomplete package or hold it. Required reporting and patient care should continue according to the study’s instructions.

 

When something is missing, identify the document or detail and explain what needs to be confirmed. A request for the date of a medication change is easier to resolve than a general request for “more clinical context.” Where possible, collect the outstanding questions so the site can address them together.

 

The site also needs to see whether a response has been accepted. Repeated reminders for a document already submitted create extra work and uncertainty about which version the reviewer has.

 

The adjudicator needs the relevant records in a form they can follow, with assessment dates and treatment changes clearly identified. Access should follow the study’s blinding rules. Reviewers need a defined process for disagreements, and any permitted reassessment needs a documented reason.

 

Recent regulatory actions have brought these adjudication and reassessment practices into sharp focus. In April 2026, the FDA proposed withdrawing approval of a vasculitis treatment (avacopan) after its notice described selected cases being readjudicated following database lock and unblinding, which changed the reported remission result. The agency concluded that those post unblinding readjudications departed from the adjudication charter and that the submitted analysis did not reliably establish effectiveness, an issue that subsequently led to the retraction of the pivotal trial publication and an EMA recommendation to revoke authorization in June 2026. For study teams, the lesson reaches beyond any single trial: how cases are selected, what reviewers know, and how reassessments are governed directly affect whether an endpoint analysis holds up to regulatory scrutiny. A complete audit trail, reviewer independence, strict blinding, and charter rules established before results are known are all essential parts of that work.

 

At the same time, the site should be able to see what happens next: another specific question, confirmation that review is underway, or a completed determination. If new information is requested, it should be clear how to submit it without losing the earlier record. Otherwise, uncertainty about the review becomes another task for staff to chase.

 

CISYS uses WebEAS to support study specific adjudication processes, including routing cases to designated reviewers, enforcing independent or consensus reviews, and documenting their assessments with a complete audit trail. WebFXP supports the exchange of source records, while WebAIRedact helps prepare documents for blinded review. The study team defines the review rules and who is responsible for each decision.

 

A better process gives coordinators fewer avoidable return requests, gives adjudicators the information needed to finish the review, and gives the study team a decision record it can stand behind when the trial is complete. To download our capabilities overview or discuss the steps that are slowing your study down ahead of ACR Convergence, visit cisys.com/currentevents.