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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030475
Receipt No. R000034772
Scientific Title Characteristics and Publication Bias of Clinical Trials Supporting Immune Checkpoint Inhibitors and Other Newest Anticancer Drugs Recently Approved by the US Food and Drug Administration
Date of disclosure of the study information 2017/12/23
Last modified on 2019/06/13

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Basic information
Public title Characteristics and Publication Bias of Clinical Trials Supporting Immune Checkpoint Inhibitors and Other Newest Anticancer Drugs Recently Approved by the US Food and Drug Administration
Acronym Publication Bias of Clinical Trials for Newest Anticancer Drugs
Scientific Title Characteristics and Publication Bias of Clinical Trials Supporting Immune Checkpoint Inhibitors and Other Newest Anticancer Drugs Recently Approved by the US Food and Drug Administration
Scientific Title:Acronym Publication Bias of Clinical Trials for Newest Anticancer Drugs
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the publication status of trials submitted to the FDA for newly approved anticancer drugs, especially for immune checkpoint inhibitors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of full publication within 2 years after the FDA approval
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 We will identify all the immune checkpoint inhibitors for the treatment of any cancers newly approved by the FDA between 2011 and 2014 at the Center for Drug Evaluation and Research Web site, available at http://www.fda.gov/cder/da/da.htm. We will also identify all the other anticancer drugs for the treatment of any cancers newly approved by the FDA between 2011 and 2014, and randomly select 10 drugs among them. For each drug, we will retrieve the FDA Summary Basis for Approval and evaluate the medical and statistical review documents to identify clinical trials submitted by the sponsor.
Key exclusion criteria We will exclude the drugs to treat drug side effects, cancer pain, other conditions, or cancer prevention.
Target sample size 13

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Omae
Organization Fukushima Medical University Hospital
Division name Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)
Zip code 9601295
Address 1 Hikarigaoka, Fukushima city, Fukushima
TEL 0245471471
Email omae416@fmu.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Omae
Organization Fukushima Medical University Hospital
Division name Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)
Zip code 9601295
Address 1 Hikarigaoka, Fukushima city, Fukushima
TEL 0245471471
Homepage URL
Email omae416@fmu.ac.jp

Sponsor
Institute Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email None

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
2017 Year 12 Month 23 Day

Related information
URL releasing protocol http://ebmh.med.kyoto-u.ac.jp/r-meta.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 12 Month 13 Day
Date of IRB
2017 Year 12 Month 13 Day
Anticipated trial start date
2017 Year 12 Month 26 Day
Last follow-up date
2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 01 Day
Date analysis concluded

Other
Other related information For each submitted trial, we will record the following characteristics when available in the FDA documents: the drug name (generic and trade), the initial approval date (month, year), approval status (accelerated or standard), drug target, delivery method, dosage and evaluation schedules, indication, the number and location of study, names of the sponsors, the name of the principal investigator, industry affiliation of the authors, study phase, purposes of the trials (efficacy and/or safety and/or pharmacokinetics), study type (superiority trial or non-inferiority trial or equivalence trial), the number of arms, control conditions, planned sample size, planned difference to detect, the number of study par, the primary and secondary outcomes, sample size in the primary analysis, effect size of the primary outcome, statistical significance of the primary outcome

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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