Evidence map›Paper›PMID 34837487›Full record

ArticleClinical pharmacology in drug development2021

Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

Masaru Hirano, Masanori Yamada, Toshiaki Tanaka, Toshiko Koue, Tomohisa Saito, Mitsuo Higashimori, Hisao Ochiai, Junichi Yamamoto, Saori Yaguchi, Sachiko Mita and 2 more

Abstract read
In one paragraph

Article in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
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

12 authors.

Masaru HiranoTranslational Medicine Japan, Novartis Institutes for Biomedical Research, Novartis Pharma K.K., Tokyo, Japan.
Masanori YamadaClinical Pharmacology Asian Hub, GlaxoSmithKline K.K., Tokyo, Japan.
Toshiaki TanakaClinical Sciences, Research & Development Japan, Bayer Yakuhin Ltd., Tokyo, Japan.
Toshiko KoueClinical Sciences, Research & Development Japan, Bayer Yakuhin Ltd., Tokyo, Japan.
Tomohisa SaitoClinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Mitsuo HigashimoriScience & Data Analytics, R&D, AstraZeneca K.K., Osaka, Japan.
Hisao OchiaiNon-Clinical, Chemistry, Manufacturing and Control Development & Translational Medicine, Research & Development Institute, Merck Biopharma Co., Ltd., Tokyo, Japan.
Junichi YamamotoClinical Pharmacology, Strategy & Planning for East Asia Region, UCB Japan Co., Ltd., Tokyo, Japan.
Saori YaguchiClinical, Medical, Regulatory Development Division, Novo Nordisk Pharm Ltd., Tokyo, Japan.
Sachiko MitaClinical Pharmacology Department, Quantitative Sciences Division, R&D, Janssen Pharmaceutical K.K., Tokyo, Japan.
Katsutoshi HaraClinical Pharmacology Asian Hub, GlaxoSmithKline K.K., Tokyo, Japan.
EFPIA Japan Technical Committee PK/PD Task Force

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Drug ApprovalEthnicityHumansJapandosage regimendrug doseethnic sensitivity/differenceJapanesephase I studyregulatory science

Identifiers

PMID34837487
PMCPMC9299455

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.