Endpoint Strategy

Endpoint selection, estimands, hierarchy, and interpretation.

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.

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.

Endpoint Strategy

Endpoint Adjudication: Preparing a Charter and a Complete Case Packet

How clinical trial teams structure an endpoint adjudication charter and case-packet completeness rules before the first reported event under FDA and ICH E6(R3) guidance.

Sep 2721 minBy Ran Chen

A closed anonymous clinical trial endpoint adjudication case-packet folder tied with twill tape beside illegible hospital records, an ECG strip, lab forms, and reading glasses on a study desk

Endpoint Strategy

Site Feasibility: Can This Site Deliver the Endpoint Assessments?

How clinical trial teams derive site feasibility questions from protocol endpoints to verify assessment capabilities, score red flags, and inform risk-based monitoring.

Sep 2123 minBy Ran Chen

A paper trial feasibility questionnaire with tick boxes, a handheld measurement device, a blank tablet, specimen vials, a stopwatch, and an evaluation pencil arranged on a desk

Endpoint Strategy

ICH M11 Protocol Endpoints: Writing Definitions That Can Be Executed and Reported

How clinical trial teams write executable endpoint definitions in ICH M11 Section 3, integrating SPIRIT-Outcomes elements and aligning Sections 1.3, 7, 8, and 10.

Sep 1821 minBy Ran Chen

An open unbranded paper protocol notebook and an unmarked schedule grid sheet on warm parchment alongside a closed oxblood binder and a dark fountain pen on a wooden desk.

Endpoint Strategy

FDA Surrogate Endpoint Table: How to Use It Without Assuming Qualification

How clinical development teams can evaluate FDA's surrogate endpoint table across indication, mechanism, and approval pathway without conflating listing with formal qualification.

Sep 1418 minBy Ran Chen

A research-journal still life with an unmarked columnar notebook, an oxblood leather journal, a charcoal fountain pen, and an unbranded glass laboratory vial on warm parchment

Endpoint Strategy

ICH E8(R1) Critical-to-Quality Endpoints: Protocol Design Rules

A methodological guide to identifying critical-to-quality endpoint factors under ICH E8(R1) and locking definitions, estimands, and feasibility before protocol freeze.

Sep 1219 minBy Ran Chen

Editorial still life of study planning materials with an oxblood binder, measurement caliper, and blank card on warm parchment

Endpoint Strategy

ICH E6(R3): An Endpoint and eClinical Implementation Checklist

A step-by-step implementation checklist for clinical development and biostatistics teams to align trial endpoints, computerized systems, and data governance with finalized ICH E6(R3) standards.

Aug 2611 minBy Ran Chen