UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
抗がん剤臨床試験における検出バイアス：メタ疫学研究

英語
Detection bias in open-label trials of cancer drug: a meta-epidemiologic study

一般向け試験名略称/Acronym

日本語
抗がん剤臨床試験における検出バイアス：メタ疫学研究

英語
Detection bias in open-label trials of cancer drug: a meta-epidemiologic study

科学的試験名/Scientific Title

日本語
抗がん剤臨床試験における検出バイアス：メタ疫学研究

英語
Detection bias in open-label trials of cancer drug: a meta-epidemiologic study

科学的試験名略称/Scientific Title:Acronym

日本語
抗がん剤臨床試験における検出バイアス：メタ疫学研究

英語
Detection bias in open-label trials of cancer drug: a meta-epidemiologic study

試験実施地域/Region

日本/Japan	アジア（日本以外）/Asia(except Japan)
北米/North America	南米/South America
オセアニア/Australia	欧州/Europe
アフリカ/Africa

対象疾患名/Condition

日本語
抗がん剤治療の非盲検化試験で、盲検化・非盲検化評価者によりアウトカムを評価している試験。

英語
Open-label trials of cancer drug assessed by both blinded and nonblinded adjudicators.

疾患区分1/Classification by specialty

該当せず/Not applicable

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
抗がん剤の非盲検化臨床試験における、検出バイアスを評価すること。

英語
To evaluate detection bias in open-label trials of cancer drugs.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語
なし

英語
No

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

実務的/Pragmatic

試験のフェーズ/Developmental phase

該当せず/Not applicable

主要アウトカム評価項目/Primary outcomes

日本語
無増悪生存期間に対する盲検化ハザード比と非盲検化ハザード比の比（ratio of hazard ratio: RHR）

英語
Ratio of hazard ratio (RHR: HRnonblinded by HRblinded) of progression free survival (PFS)

副次アウトカム評価項目/Key secondary outcomes

日本語
客観的奏功率に対する盲検化オッズ比と非盲検化オッズ比の比（ratio of odds ratio: ROR）

英語
Ratio of odds ratio (ROR: ORnonblinded by ORblinded) of objective response ratio (ORR)

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

適用なし/Not applicable

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
抗がん剤治療効果の評価のための非盲検化優劣性デザインによるランダム化比較試験。対象とするがんは乳がん、肺がん、大腸がん、前立腺がん、胃がん、腎癌とする。

英語
Randomized, controlled, open-label, parallel-group superiority trials investigating the efficacy of anticancer agents. Included cancers are focused on breast, lung, colorectal, prostate, stomach and kidney cancers.

除外基準/Key exclusion criteria

日本語
盲検化デザイン、非劣勢試験、同等性試験、単群試験。

英語
Blinded, non-inferiority, equivalence, and single-arm trials.

目標参加者数/Target sample size

0

責任研究者/Name of lead principal investigator

日本語

名	船田
ミドルネーム
姓	哲

英語

名	Satoshi
ミドルネーム	Funada
姓	Funada

所属組織/Organization

日本語
京都大学

英語
Kyoto University

所属部署/Division name

日本語
京都大学大学院 医学研究科 社会健康医学系専攻 健康増進・行動学分野

英語
Department of Health Promotion and Human Behavior, Kyoto University School of Public Health

郵便番号/Zip code

606-8501

住所/Address

日本語
京都市左京区吉田近衛町

英語
Yoshida Konoe-cho, Sakyo-ku, Kyoto

電話/TEL

075-753-9492

Email/Email

sfunada@kuhp.kyoto-u.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	船田
ミドルネーム
姓	哲

英語

名	Satoshi
ミドルネーム	Funada
姓	Funada

組織名/Organization

日本語
京都大学

英語
Kyoto University

部署名/Division name

日本語
京都大学大学院 医学研究科 社会健康医学系専攻 健康増進・行動学分野

英語
Department of Health Promotion and Human Behavior, Kyoto University School of Public Health

郵便番号/Zip code

606-8501

住所/Address

日本語
京都市左京区吉田近衛町

英語
Yoshida Konoe-cho, Sakyo-ku, Kyoto

電話/TEL

075-753-9492

試験のホームページURL/Homepage URL

Email/Email

sfunada@kuhp.kyoto-u.ac.jp

機関名/Institute

日本語
その他

英語
Department of Health Promotion and Human Behavior, Kyoto University School of Public Health

機関名/Institute
（機関選択不可の場合）

日本語
京都大学

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
無し

英語
No

機関名/Organization
（機関選択不可の場合）

日本語
なし

組織名/Division

日本語

組織の区分/Category of Funding Organization

自己調達/Self funding

研究費拠出国/Nationality of Funding Organization

日本語
日本

英語
Japan

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
京都大学大学院医学研究科・医学部及び医学部附属病院 医の倫理委員会

英語
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

住所/Address

日本語
京都市左京区吉田近衛町

英語
Yoshida Konoe-cho, Sakyo-ku, Kyoto

電話/Tel

075-753-4680

Email/Email

ethcom@kuhp.kyoto-u.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2021

年

06

月

22

日

プロトコル掲載URL/URL releasing protocol

https://osf.io/csx7h/

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

https://ebm.bmj.com/content/early/2023/08/16/bmjebm-2023-112332.long

組み入れ参加者数/Number of participants that the trial has enrolled

114

主な結果/Results

日本語
We retrieved 1197 records of oncological open-label trials after full-text screening. We identified 171 records (PFS: 149 records, ORR: 136 records) in which both central reviewers and local investigators were used, and included 114 records (PFS: 92 records, ORR: 74 records) for meta-analyses. While the RHR for PFS was 0.95 (95% CI 0.91 to 0.98), the ROR of ORR was 1.00 (95% CI 0.91 to 1.09). The results remained unchanged in the prespecified sensitivity analysis.

英語
We retrieved 1197 records of oncological open-label trials after full-text screening. We identified 171 records (PFS: 149 records, ORR: 136 records) in which both central reviewers and local investigators were used, and included 114 records (PFS: 92 records, ORR: 74 records) for meta-analyses. While the RHR for PFS was 0.95 (95% CI 0.91 to 0.98), the ROR of ORR was 1.00 (95% CI 0.91 to 1.09). The results remained unchanged in the prespecified sensitivity analysis.

主な結果入力日/Results date posted

2023

年

08

月

28

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
The analysis included 114 records, 92 for PFS and 74 for ORR. The majority of the trials were phase III (n=74); the most common tumour types were non-small cell lung cancer (n=29), breast cancer (n=22) and renal cell cancer (n=14); and the most common type of drug was targeted therapy (n=70). PFS was the primary outcome in 82 records, whereas ORR was the primary outcome in 13. Most of the reports were from high-impact factor (>10) journals (n=102), with only 5 funded by the public sector.

英語
The analysis included 114 records, 92 for PFS and 74 for ORR. The majority of the trials were phase III (n=74); the most common tumour types were non-small cell lung cancer (n=29), breast cancer (n=22) and renal cell cancer (n=14); and the most common type of drug was targeted therapy (n=70). PFS was the primary outcome in 82 records, whereas ORR was the primary outcome in 13. Most of the reports were from high-impact factor (>10) journals (n=102), with only 5 funded by the public sector.

参加者の流れ/Participant flow

日本語
We identified 6339 records, 1517 of which were eligible after screening titles and abstracts. From 1517 records, we retrieved 1197 eligible records after full-text screening and assessed the adjudicators of PFS and ORR. A total of 181 records (PFS: 157 records, ORR: 141 records) were adjudicated by both central reviewers and local investigators (online supplemental table 1), and the trend of the prevalence of outcome adjudicators did not change from 2010 to 2021 in both PFS (online supplemental figure 2) and ORR (online supplemental figure 3). Of the 181 records, we excluded 10 due to data duplication and included the remaining records that could extract the outcomes adjudicated by both central reviewers and local investigators. Finally, we included 114 records in this analysis, of which 92 were analysed for PFS and 74 for ORR. In other words, among the records that we judged were adjudicated by both central reviewers and local investigators for PFS, only 61.7% (92/149) reported results from both assessors and 54.4% (74/136) for ORR. Online supplemental materials list the exclusion criteria for records during the full-text screening stage (n=320), data extraction stage (n=57) and duplication records stage (n=10). We sent 121 emails to the corresponding authors to request details of the data (26 October 2022) and received 15 responses, of which only one provided sufficient information. The other 14 corresponding authors stated that they could not access the data.

英語
We identified 6339 records, 1517 of which were eligible after screening titles and abstracts. From 1517 records, we retrieved 1197 eligible records after full-text screening and assessed the adjudicators of PFS and ORR. A total of 181 records (PFS: 157 records, ORR: 141 records) were adjudicated by both central reviewers and local investigators (online supplemental table 1), and the trend of the prevalence of outcome adjudicators did not change from 2010 to 2021 in both PFS (online supplemental figure 2) and ORR (online supplemental figure 3). Of the 181 records, we excluded 10 due to data duplication and included the remaining records that could extract the outcomes adjudicated by both central reviewers and local investigators. Finally, we included 114 records in this analysis, of which 92 were analysed for PFS and 74 for ORR. In other words, among the records that we judged were adjudicated by both central reviewers and local investigators for PFS, only 61.7% (92/149) reported results from both assessors and 54.4% (74/136) for ORR. Online supplemental materials list the exclusion criteria for records during the full-text screening stage (n=320), data extraction stage (n=57) and duplication records stage (n=10). We sent 121 emails to the corresponding authors to request details of the data (26 October 2022) and received 15 responses, of which only one provided sufficient information. The other 14 corresponding authors stated that they could not access the data.

有害事象/Adverse events

日本語
NA

英語
NA

評価項目/Outcome measures

日本語
Ratio of hazard ratio (RHR)
Ratio of odds ratio (ROR)

英語
Ratio of hazard ratio (RHR)
Ratio of odds ratio (ROR)

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2021

年

06

月

25

日

倫理委員会による承認日/Date of IRB

2021

年

06

月

25

日

登録・組入れ開始（予定）日/Anticipated trial start date

2021

年

07

月

01

日

フォロー終了(予定)日/Last follow-up date

2022

年

03

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
ランダム効果モデルを仮定した逆分散法によるRHRとRORのメタ解析を主解析とする。感度解析、サブグループ解析も行う。

英語
We will perform a meta-analysis of RHR and ROR with inverse variance methods using a random-effect model. We will also perform sensitivity analysis and subgroup analysis.

登録日時/Registered date

2021

年

06

月

22

日

最終更新日/Last modified on

2023

年

08

月

28

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000050668

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050668