UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030475
Receipt number 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 2019/10/29 06:38:31

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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 or person

Institute

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

Institute

Department

Personal name



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

Published


Result

URL related to results and publications

https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-6232-x

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

2019 Year 10 Month 24 Day

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 10 Month 29 Day



Link to view the page

Value
https://center6.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