UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031654 |
|---|---|
| Receipt number | R000036147 |
| Scientific Title | Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses |
| Date of disclosure of the study information | 2018/03/10 |
| Last modified on | 2020/09/09 10:24:34 |
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Basic information
Public title
Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Acronym
Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Scientific Title
Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Scientific Title:Acronym
Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Region
| Japan |
Condition
Condition
randomized controlled trials that are eligible for IPD meta-analysis
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to quantify data availability bias among SRs with IPD meta-analysis with less than 100% retrieval rate.
Basic objectives2
Others
Basic objectives -Others
to assess RCT-level factors associated with the provision of IPD data, and (ii)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Our primary outcome is a discrepancy of AD meta-analytic results between RCTs contributing IPD and RCTs not contributing to IPD
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All therapeutic RCTs included in SRs that fulfill the following criteria will be eligible: (i) SRs with IPD meta-analysis, (ii) SRs that include only RCTs comparing an active intervention against a control condition in terms of a dichotomous outcome, (iii) SRs that report full reference list of the included RCTs, and (iv) SRs written in English.
Key exclusion criteria
The following SRs will be excluded: (v) SRs published before 2011, (vi) SRs where all included RCTs provide IPD data, (vii) SRs of diagnostic or prognostic studies, and (vii) SRs with network meta-analysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Tsujimoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Healthcare Epidemiology
Zip code
606-8315
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
81-75-753-9467
yssh0108@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Tsujimoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Healthcare Epidemiology
Zip code
606-8315
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
81-75-753-9467
Homepage URL
http://ebmh.med.kyoto-u.ac.jp/files/Protocol%20for%20a%20study%20on%20data%20availability%20bias.pdf
yssh0108@yahoo.co.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
http://ebmh.med.kyoto-u.ac.jp/files/Protocol%20for%20a%20study%20on%20data%20availability%20bias.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0895435619304731?via%3Dihub
Number of participants that the trial has enrolled
728
Results
see the publication
Results date posted
| 2020 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
as above
Participant flow
as above
Adverse events
none
Outcome measures
as above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 05 | Month | 22 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036147
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
