Unique ID issued by UMIN | UMIN000030475 |
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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 |
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
Publication Bias of Clinical Trials for Newest Anticancer Drugs
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
Publication Bias of Clinical Trials for Newest Anticancer Drugs
Japan |
Cancer
Hematology and clinical oncology |
Malignancy
NO
To evaluate the publication status of trials submitted to the FDA for newly approved anticancer drugs, especially for immune checkpoint inhibitors.
Safety,Efficacy
The rate of full publication within 2 years after the FDA approval
Others,meta-analysis etc
Not applicable |
Not applicable |
Male and Female
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.
We will exclude the drugs to treat drug side effects, cancer pain, other conditions, or cancer prevention.
13
1st name | Kenji |
Middle name | |
Last name | Omae |
Fukushima Medical University Hospital
Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)
9601295
1 Hikarigaoka, Fukushima city, Fukushima
0245471471
omae416@fmu.ac.jp
1st name | Kenji |
Middle name | |
Last name | Omae |
Fukushima Medical University Hospital
Department of Innovative Research and Education for Clinicians and Trainees (DiRECT)
9601295
1 Hikarigaoka, Fukushima city, Fukushima
0245471471
omae416@fmu.ac.jp
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health
None
Self funding
None
None
None
None
NO
2017 | Year | 12 | Month | 23 | Day |
http://ebmh.med.kyoto-u.ac.jp/r-meta.html
Published
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-6232-x
0
2019 | Year | 10 | Month | 24 | Day |
Completed
2017 | Year | 12 | Month | 13 | Day |
2017 | Year | 12 | Month | 13 | Day |
2017 | Year | 12 | Month | 26 | Day |
2019 | Year | 02 | Month | 01 | Day |
2018 | Year | 11 | Month | 01 | Day |
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
2017 | Year | 12 | Month | 19 | Day |
2019 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034772
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