Evidence map›Paper›PMID 31312766›Full record

ArticleJACC. Basic to translational science2019

Phase II Trials in Drug Development and Adaptive Trial Design.

Gail A Van Norman

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JACC. Basic to translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  17. A Deployed Online Reinforcement Learning Algorithm In An Oral Health Clinical Trial.Proceedings of the ... AAAI Conference on Artificial Intelligence. AAAI Conference on Artificial Intelligence · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Gail A Van NormanDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.

Indexed as

AD, adaptive (trial) designadaptive designbiomarker studiesCV, cardiovascularEMA, European Medicines Agencyfalse discovery rateFDA, Food and Drug AdministrationFDR, false discovery rateHF, heart failuremultiplicity problemphase II clinical trialsRP-II, randomized phase II studiesSA-II, single-arm phase II studies

Identifiers

PMID31312766
PMCPMC6609997

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.