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The Design of Clinical Trials for New Molecularly Targeted Compounds: Progress and New Initiatives

2002· review· en· 18 citations· W2023584100 on OpenAlex· 10.2174/1381612023393099

Why is this work in the frame?

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

Canadian affiliationAn author listed a Canadian institution. This is the only route the usual frame has.

Full frame distilled prediction

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.

Candidate categories
Metaresearch, Meta-epidemiology (narrow)
Consensus categories
Metaresearch
Domain
Candidate signal: noneConsensus signal: none
Study design
Candidate signal: Other designConsensus signal: none
Genre
Candidate signal: ReviewConsensus signal: Review
Teacher disagreement score
0.921
Threshold uncertainty score
1.000
Validation status
machine_predicted_unvalidated · codex-gemma-dda1882f352a

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0510.428
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0090.002
Bibliometrics0.0000.001
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

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

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.

Opus teacher head0.970
GPT teacher head0.744
Teacher spread
0.226 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Abstract

Investigators involved in the development of cancer therapeutics are testing new trial designs and endpoints in order to accommodate the perceived challenges in defining appropriate doses and schedules for further testing. Many new agents with specific molecular targets have entered clinical development or are being considered for development. While some of the agents have both toxicity and antitumour efficacy apparent at clinically achievable doses, thus the use of traditional algorithms is appropriate, others have significant clinical activity at doses considerably lower than the maximum tolerated dose. New initiatives in clinical trial design, both phase I and phase II may allow the development of appropriate plans for the development of these new molecularly targeted agents. Measures of target effect (tissue or imaging) are now commonly included in early trials of new targeted compounds, in an attempt to demonstrate proof of principle as well as guide dose selection. Phase II trial designs including novel correlative, imaging and clinical endpoints are being tested. Alternate endpoints such as progression or time to progression are being increasingly considered, and novel designs such as randomized discontinuation designs, multinomial designs and growth modulation indices are being prospectively tested. Progress in this area of early trial design are reviewed.

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.

The record

Venue
Current Pharmaceutical Design
Topic
Statistical Methods in Clinical Trials
Field
Mathematics
Canadian institutions
Ontario Institute for Cancer ResearchQueen's University
Funders
not available
Keywords
Clinical trialClinical study designMedicineClinical endpointDiscontinuationEndpoint DeterminationMedical physicsDrug developmentRandomized controlled trialSurrogate endpointComputer sciencePharmacologyInternal medicineDrug
Has abstract in OpenAlex
yes