UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039281 |
|---|---|
| Receipt number | R000044804 |
| Scientific Title | Characteristics of pre- and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration: A meta-epidemiological investigation |
| Date of disclosure of the study information | 2020/02/29 |
| Last modified on | 2022/09/13 10:33:27 |
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Basic information
Public title
Characteristics of pre- and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
Acronym
Accelerated approval of non-cancer drugs by the US FDA
Scientific Title
Characteristics of pre- and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration: A meta-epidemiological investigation
Scientific Title:Acronym
Accelerated approval of non-cancer drugs by the US FDA
Region
| Japan |
Condition
Condition
All the drug indications other than cancer treatment that received accelerated approval by the FDA
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First, we will assess trends in the FDA utilization of its accelerated approval program for non-cancer drugs. We will further assess the extent to which confirmatory studies were completed and accelerated approvals were converted to regular approvals as well as the time between accelerated approval and fulfillment of post-approval requirements. The frequency of post-market safety-related label modifications and/or withdrawals will be also evaluated to determine whether the drugs demonstrated clinically meaningful benefits.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion of post-approval confirmatory studies
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 the drug indications that received accelerated approval by the FDA since 1992
Key exclusion criteria
The indications approved for cancer treatment
Target sample size
73
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
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
0245471471
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
960-1295
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
TEL
0245471471
Homepage URL
omae416@fmu.ac.jp
Sponsor or person
Institute
Department of Health Promotion and Human Behavior, Kyoto University School of
Public Health in the Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation, the Health Care Science Institute
Organization
Division
Category of Funding Organization
Non profit foundation
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
0245471471
omae416@fmu.ac.jp
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
| 2020 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2020.05.18.20105148v1
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2022.30973?gues
Number of participants that the trial has enrolled
57
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 09 | 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
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 27 | Day |
Other
Other related information
This study does not involve individual patient information; it involves publicly available trial-level data, and therefore, institutional review board approval is not be required.
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044804
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
