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Record W2507054063 · doi:10.1007/978-1-4899-7654-3_29

Bridging the Chasm Between Scientific Discovery and a Pivotal Clinical Trial for a CNS Disorder: A Checklist

2016· book-chapter· en· W2507054063 on OpenAlexaff
John D. Steeves

Bibliographic record

VenueTranslational Neuroscience · 2016
Typebook-chapter
Languageen
FieldMedicine
TopicTraumatic Brain Injury and Neurovascular Disturbances
Canadian institutionsUniversity of British ColumbiaInternational Collaboration On Repair DiscoveriesVancouver Coastal HealthVancouver General Hospital
Fundersnot available
KeywordsChecklistClinical trialMedicineNeuroscienceIntensive care medicineAsk pricePsychologyPathologyCognitive psychology

Abstract

fetched live from OpenAlex

The central nervous system (CNS) is difficult to treat effectively after damage, whether the situation is congenital, traumatic, or degenerative. The effective translation of a novel preclinical discovery to a clinically meaningful human treatment is demanding and initially governed by fundamental achievements at the preclinical development level. Good laboratory practices (GLPs) are increasingly being adopted, as they provide all neurological investigators with increased confidence for the results. GLPs are demanding and ask scientists to adhere to many of the demanding criteria intrinsic to human studies. The subsequent preclinical development of a therapeutic is equally important and outlines the safety, dose, fate, window of opportunity, and route of administration. Human trials are channeled by established guidelines, but CNS clinical studies involve target populations that are heterogeneous and often rely on subjective (ordinal) outcome tools that can be questioned for their ability to accurately and sensitively discern subtle treatment effects. Improved solutions for the following concerns are evolving quickly:

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)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.708
Threshold uncertainty score0.820

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0010.002
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
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 head0.102
GPT teacher head0.348
Teacher spread0.246 · 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.

The models applied no category: nothing in the taxonomy fit this work.
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

Citations0
Published2016
Admission routes1
Has abstractyes

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