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Record W4225831680 · doi:10.1075/jial.21002.ric

Localization of clinical research

2021· article· en· W4225831680 on OpenAlex

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

aboutThe title or abstract carries a Canadian signal from the geographic lexicon.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueThe Journal of Internationalization and Localization · 2021
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
Fundersnot available
KeywordsObservational studyClinical trialSubjectivityPolitical scienceProcess (computing)Perspective (graphical)Public relationsMedical educationPsychologyBusinessMedicineComputer sciencePathologyArtificial intelligence

Abstract

fetched live from OpenAlex

Abstract Clinical research using human participants to further medical knowledge has been at the forefront in 2021. Clinical research studying the efficacy of treatments can be categorised in two broad categories as ‘observational studies’ or ‘clinical trials’. Written from the perspective of a localization project manager at Vitaccess, which conducts global digital research for biopharmaceutical companies, this paper discusses five core challenges that impact the localization of such a study launched in France, Italy, Germany, Belgium, Spain, Japan, the UK, the US and Canada, conducted via a smartphone app. The localization project manager role provides a bridge between translators, revisers, ethics bodies, authors, legal, and medical reviewers, enabling oversight to keep the balance between launching the study globally and enabling each country to have the content and structure tailored to their cultural and linguistic expectations through localization. The main challenges in localizing a real-world evidence study is the complexity and volume of ethical, legal, and medical feedback required for the content of the study, which is further complicated by the need to target different countries and languages. Subjectivity and variance in the feedback per country also pose difficulties. International harmonisation of ethical, medical, and legal reviews of such global studies could streamline the process.

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.

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)0.013
metaresearch head score (Gemma)0.029
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.928
Threshold uncertainty score0.979

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0130.029
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.001
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
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 head0.605
GPT teacher head0.655
Teacher spread0.050 · 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