Evidence map›Paper›PMID 38535873›Full record

ArticleJapanese journal of clinical oncology2024

Transitional dynamics in oncology clinical trials: evaluating the impact of Clinical Trials Act on cooperative groups.

Kenichi Nakamura, Koji Takeda, Akiko M Saito, Miho Kato, Shinya Sato, Satoshi Nakagawa, Yasuyuki Kawamoto, Eiji Oki, Isamu Okamoto, Hiroaki Okamoto and 5 more

Erratum issuedOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Japanese journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.0field-weighted citation impact, top 26% of its field
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

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 2 countries.

Kenichi NakamuraJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Koji TakedaWest Japan Oncology Group, Department of Sectretariat, Osaka, Japan.
Akiko M SaitoClinical Research Center, Japan Children's Cancer Group, NHO Natoya Medical Center, Nagoya, Japan.
Miho KatoJapan Children's Cancer Group, Department of Childhood Cancer Data Management, National Center for Child Health and Development, Tokyo, Japan.
Shinya SatoJapan Adult Leukemia Study Group, Department of Hematology, Nagasaki University, Nagasaki, Japan.
Satoshi NakagawaJapanese Gynecologic Oncology Group, Department of Study Management, Translational Research Center for Medical Innovation, Kobe, Japan.
Yasuyuki KawamotoHokkaido Gastrointestinal Cancer Study Group, Division of Cancer Center, Hokkaido University, Sapporo, Japan.
Eiji OkiKyushu Study Group of Clinical Cancer, Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Isamu OkamotoLung Oncology Group in Kyushu, Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Hiroaki OkamotoThoracic Oncology Research Group, Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Hiroshi KatayamaJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Junki MizusawaJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Harumi KabaJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Taro ShibataJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJapan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan.
Japan Clinical Cancer Research Organization · JPAichi Cancer Center · JPGynecologic Oncology Group · USHokkaido University Hospital · JPKyushu University · JPMolecular Oncology (United States) · USNational Hospital Organization Kyushu Cancer Center · JPOsaka Hospital · JPUniversity of Nagasaki · JP

Funding

National Cancer Center Research and Development Fund 2023-A-13
6 · The paper itself

Abstract

objectivelarge-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown.

methodsa survey was conducted across the nine major cooperative groups that constitute the Japan Cancer Trials Network to assess the impact of Clinical Trials Act on the number of newly initiated trials from fiscal year (from 1 April to 31 March) 2017 to 2022 and that of ongoing trials on 1 April in each year from 2018 to 2023.

resultsthe number of newly initiated trials dropped from 38 trials in fiscal year 2017 to 26 trials in fiscal year 2018, surged to 50 trials in fiscal year 2019, but then gradually decreased to 25 trials by fiscal year 2022. Specified clinical trials decreased from 32 trials in fiscal year 2019 to 12 trials in fiscal year 2022. The number of ongoing trials was 220 trials in 2018, peaked at 245 trials in 2020, but then gradually decreased to 219 trials by 2023. The number of specified clinical trials has been in consistent decline. By April 2023, of the 20 ongoing non-specified clinical trials, nine adhered to Clinical Trials Act and 11 followed the Ethical Guidelines for Medical and Health Research Involving Human Subjects.

conclusionthe number of multicentre clinical trials in oncology gradually decreased after the Clinical Trials Act's enforcement, which underscores the need for comprehensive amendment of the Clinical Trials Act to streamline the operational process.

Indexed as

Clinical Trials as TopicMedical OncologyNeoplasmsHumansJapanSurveys and Questionnairescancer cooperative groupclinical trial registryClinical Trials Actgood clinical practiceinternational clinical trial

Identifiers

PMID38535873
PMCPMC11228844
OpenAlexW4393234404

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.