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An overview of platform trials with a checklist for clinical readers

2020· review· en· W3026023260 on OpenAlexaff
Jay Park, Ofir Harari, Louis Dron, Richard Lester, Kristian Thorlund, Edward J. Mills

Bibliographic record

VenueJournal of Clinical Epidemiology · 2020
Typereview
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsMcMaster UniversityImpactUniversity of British Columbia
Fundersnot available
KeywordsChecklistMedicineClinical trialMedical physicsMEDLINEPsychologyPathologyPolitical science

Abstract

fetched live from OpenAlex

OBJECTIVES: The objective of the study was to outline key considerations for general clinical readers when critically evaluating publications on platform trials and for researchers when designing these types of clinical trials. STUDY DESIGN AND SETTING: In this review, we describe key concepts of platform trials with case study discussion of two hallmark platform trials in STAMPEDE and I-SPY2. We provide reader's guide to platform trials with a critical appraisal checklist. RESULTS: Platform trials offer flexibilities of dropping ineffective arms early based on interim data and introducing new arms into the trial. For platform trials, it is important to consider how interventions are compared and evaluated throughout and how new interventions are introduced. For intervention comparisons, it is important to consider what the primary analysis is, what and how many interventions are active simultaneously, and allocation between different arms. Interim evaluation considerations should include the number and timing of interim evaluations and outcomes and statistical rules used to drop interventions. New interventions are usually introduced based on scientific merits, so consideration of these merits is important, together with the timing and mechanisms in which new interventions are added. CONCLUSION: More efforts are needed to improve the scientific literacy of platform trials. Our review provides an overview of the important concepts of platform trials.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.146
metaresearch head score (Gemma)0.338
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.854
Threshold uncertainty score0.772

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.1460.338
Meta-epidemiology (narrow)0.0050.003
Meta-epidemiology (broad)0.0070.009
Bibliometrics0.0230.015
Science and technology studies0.0020.003
Scholarly communication0.0070.009
Open science0.0060.007
Research integrity0.0080.008
Insufficient payload (model declined to judge)0.0390.015

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.983
GPT teacher head0.803
Teacher spread0.180 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designNot applicable
DomainMethods
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations134
Published2020
Admission routes1
Has abstractyes

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