The journal

Latest essays

Independent analysis of endpoint strategy, measurement operations, and clinical trial systems.

FDA CGM Data Submission: Tracing Sensor Epochs to the Final Analysis Dataset

How FDA's May 2026 CGM technical specifications link SDTM LB epochs, ADCGM phantom rows and ADCGMEN completeness variables, and what the SAP must lock first.

Oct 1224 minBy Ran Chen

An unbranded white disc on parchment beside a pen trace that runs onto graph paper and breaks off at a brass pin on an oxblood thread, with a stack of blank cards at upper right.

Estimands & Statistics

Competing Risks: State the Probability Question Before the Model

When competing events occur, choosing between cumulative incidence and cause-specific hazard depends on the probability question and ICH E9(R1) estimand strategy.

Oct 1115 minBy Ran Chen

Research-journal editorial still life of a paper timeline branching into two mutually exclusive endpoints under a pocket watch and a sealed envelope, symbolizing competing risks

Endpoint Strategy

Central Imaging Reads: Plan Disagreements and Missing Images

How clinical trial teams structure imaging charters to handle reader disagreement, unreadable series, and missing scans before database lock.

Oct 1014 minBy Ran Chen

Stacked chest-radiograph sheets with a brass loupe beside blank ruled papers tied with an oxblood ribbon and a muted blue archive box.

Data Quality & Technology

Wearable Endpoints: Separating Non-Wear Time From True Inactivity

How clinical trial teams choose wearable non-wear rules, define valid days, and distinguish missing observations from intercurrent events.

Oct 914 minBy Ran Chen

Unbranded charcoal activity sensor band resting beside blank folded cream paper on a wooden desk.

Data Quality & Technology

Endpoint Data Before Database Lock: A Reconciliation Checklist

Which endpoint data must be reconciled and evidenced before a clinical database lock, who signs each row, and how unlock and unblinding stay controlled.

Oct 821 minBy Ran Chen

Still life on a wooden desk: a navy cloth-bound casebook closed with a strap and a plain oxblood wax seal, a grey stopwatch, two small vials with blank labels, a tablet with its screen off, and a parchment checklist with empty ruled rows.

Endpoint Strategy

PRO Burden: Deciding Which Questionnaires a Trial Actually Needs

Decide which PRO questionnaires a clinical trial needs by mapping objectives, checking combined burden, and justifying timing in a hypothetical worked example.

Oct 715 minBy Ran Chen

Blank assessment grid beside stacked notebooks, loose sheets, a pencil, and paper clips in warm window light.

Regulatory Evidence

ClinicalTrials.gov Outcome Measures: Aligning Registry and Protocol Wording

How to write ClinicalTrials.gov outcome measures from the protocol endpoint, which 42 CFR 11.64 update clock applies after an amendment, and what results QC checks.

Oct 618 minBy Ran Chen

An unbranded printed protocol page with blank, unreadable layout blocks, partly overlapped by a plain record card with three empty field rows, next to a capped pen on a wooden desk.

Measurement & Operations

Clinical Trial Assessment Windows: Recording a Late Visit Without Backdating

What to record when a trial visit falls outside its protocol window, how to classify the deviation, and when the SAP analysis window still counts the endpoint.

Oct 516 minBy Ran Chen

Still life on a dark wooden desk: an unlabeled schedule-of-assessments grid with an oxblood shaded band and a single ink circle just outside it, beside a navy cloth notebook, a black pen and a brass stopwatch.

Measurement & Operations

PRO Recall Periods: When Daily and Weekly Answers Differ

Why daily diary averages and 7-day recall scores for the same PRO items diverge, what FDA guidance says about changing a recall period, and what to lock before the eCOA build.

Oct 416 minBy Ran Chen

Still life of a small ruled daily diary card with narrow day columns beside a larger lined questionnaire sheet with a single summary column, a pencil between them on a warm wooden desk

Data Quality & Technology

Withdrawal From a Trial: Separating New Collection From Retained Data

How trial teams timestamp a withdrawal boundary, keep endpoint data already collected in an FDA-regulated database, and stop only the collection the participant has refused.

Oct 323 minBy Ran Chen

Editorial still life of a closed oxblood protocol binder and filed parchment records separated from a collection tray holding a powered-off handheld device and sealed specimen tube.

Data Quality & Technology

Endpoint Queries: Correcting Data Without Leading the Respondent

How data management teams query an endpoint discrepancy without supplying the answer, and what to do when the site confirms the original value.

Oct 221 minBy Ran Chen

Still life of an open blank protocol binder, a blank slip marked only with a charcoal stroke, a pencil, a brass magnifier, and a face-down unbranded diary on a wooden desk.

Measurement & Operations

Caregiver Diaries: Planning for a Change of Respondent

How clinical trial teams should specify caregiver eligibility, unique credentials, audit trails, and transition sensitivity analyses when diary respondents change.

Oct 123 minBy Ran Chen