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Record W2114150682 · doi:10.3899/jrheum.110656

Time for Change in the Conduct of Clinical Trials in Patients with Rheumatoid Arthritis

2011· letter· en· W2114150682 on OpenAlexvenueno aff
Joel M. Kremer

Bibliographic record

VenueThe Journal of Rheumatology · 2011
Typeletter
Languageen
FieldMedicine
TopicBiomedical Ethics and Regulation
Canadian institutionsnot available
Fundersnot available
KeywordsMedicineNothingTolerabilityClinical trialAlternative medicineRheumatoid arthritisFamily medicineInternal medicinePathologyEpistemology

Abstract

fetched live from OpenAlex

> What science can there be in a matter in which, as in all practical matters, nothing can be defined and everything depends on innumerable conditions, the significance of which is determined at a particular moment which arrives no one knows when? > > Prince Andrew, War and Peace , Leo Tolstoy Doing clinical research in rheumatology has never been easy. There really wasn’t much going on 30 years ago and a “clinical trialist” was challenged to find something to study. Then came methotrexate (MTX), and for more than 20 years trials of its efficacy, safety, tolerability, pharmacokinetics, and mechanism of action dominated the scene. It’s difficult for young clinical investigators to appreciate a therapeutic epoch that was so entirely dominated by a single drug. Back then, many were frightened by MTX and those misgivings were often transferred to patients as well as other physicians and pharmacists. We really weren’t very sure about this drug. The present clinical climate could not be more different. Nine new biologic drugs have been approved in the United States in the last 13 years, and several other new agents are almost there. While this is definitely good for patients, it has become challenging to remain an ethical trialist while succeeding in North America. That is, if a patient has insurance and can access a variety of new drugs, why would they want to participate in a study of an unproven agent in which they might get nothing more than a sugar … Address correspondence to Dr. Kremer. E-mail: jkremer{at}joint-docs.com

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 distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.018
metaresearch head score (Gemma)0.002
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesResearch integrity
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.361
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0180.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0000.000

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 head0.175
GPT teacher head0.402
Teacher spread0.227 · 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 teacher head, not a consensus.

Study designNot applicable
Domainnot available
GenreEmpirical

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

Citations2
Published2011
Admission routes1
Has abstractyes

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