UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039111 |
|---|---|
| Receipt number | R000044607 |
| Scientific Title | Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on pharmacological therapies for alcohol use disorder and the nature of results and conclusions of these reviews |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2020/01/10 02:26:26 |
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Basic information
Public title
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on pharmacological therapies for alcohol use disorder and the nature of results and conclusions of these reviews
Acronym
AUD-FCOI
Scientific Title
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on pharmacological therapies for alcohol use disorder and the nature of results and conclusions of these reviews
Scientific Title:Acronym
AUD-FCOI
Region
| North America |
Condition
Condition
Alcohol Use Disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives: Our primary objectives are (i) to characterize the nature and types of conflicts of interest (both disclosed and undisclosed) of systematic review authors and (ii) to determine whether the direction of meta-analytic pooled effect estimates, when provided, and narrative results and conclusions from systematic reviews may be influenced by having systematic review authors with conflicts of interest. Our secondary objectives will be to evaluate (i) whether an association exists between risk of bias and financial conflicts of interest of systematic review authors; and (ii) whether a relationship exists between sponsorship of systematic reviews and their reported results and conclusions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objectives: Our primary objectives are (i) to characterize the nature and types of conflicts of interest (both disclosed and undisclosed) of systematic review authors and (ii) to determine whether the direction of meta-analytic pooled effect estimates, when provided, and narrative results and conclusions from systematic reviews may be influenced by having systematic review authors with conflicts of interest. Our secondary objectives will be to evaluate whether an association exists between risk of bias and financial conflicts of interest of systematic review authors
Key secondary outcomes
(ii) whether a relationship exists between sponsorship of systematic reviews and their reported results and conclusions.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility Criteria: To be included in our study, the study design must be a systematic review and or meta-analysis. We will use the PRISMA P deNAfinition of a systematic review meta-analysis, which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. 1. Furthermore, studies will be included if they compare at least one pharmacologic therapy to another (or in combination) or if they compare a pharmacologic therapy to an nonpharmacologic therapy, such as verbal alcoholism therapy. We will include all pharmacologic therapies, regardless of whether they are indicated for treatment of AUD (acamprosate, naltrexone, and disulfiram) or whether they are used off label. We will include studies along the following stages of progression: (i) stabilization following excessive use of alcohol, (ii) relapse prevention, or (iii) recovery maintenance. Furthermore, to qualify for inclusion, systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.
Key exclusion criteria
Eligibility Criteria: To be included in our study, the study design must be a systematic review and or meta-analysis. We will use the PRISMA P deNAfinition of a systematic review meta-analysis, which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. 1. Furthermore, studies will be included if they compare at least one pharmacologic therapy to another (or in combination) or if they compare a pharmacologic therapy to an nonpharmacologic therapy, such as verbal alcoholism therapy. We will include all pharmacologic therapies, regardless of whether they are indicated for treatment of AUD (acamprosate, naltrexone, and disulfiram) or whether they are used off label. We will include studies along the following stages of progression: (i) stabilization following excessive use of alcohol, (ii) relapse prevention, or (iii) recovery maintenance. Furthermore, to qualify for inclusion, systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Matt |
| Middle name | |
| Last name | Vassar |
Organization
Oklahoma State University Center for Health Sciences
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
74107
Address
1111 W 17th St. Tulsa, OK 74107
TEL
9185821972
matt.vassar@okstate.edu
Public contact
Name of contact person
| 1st name | Matt |
| Middle name | |
| Last name | Vassar |
Organization
Oklahoma State University Center for Health Sciences
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
74107
Address
1111 W 17th St. Tulsa, OK 74107
TEL
9185821972
Homepage URL
matt.vassar@okstate.edu
Sponsor or person
Institute
Oklahoma State University Center for Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Oklahoma State University Center for Health Sciences
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oklahoma State University Center for Health Sciences
Address
1111 W 17th St. Tulsa, OK 74107
Tel
9185821972
matt.vassar@okstate.edu
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 | 01 | Month | 10 | Day |
Related information
URL releasing protocol
OSF.IO
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data Collection Process: Data extraction will be performed by the same investigators MC and MH who performed the initial screening. As before, they will be blinded to the other investigators decisions. After data extraction, both investigators will meet and resolve any discrepancies. JMA and MV will be available for third party adjudication on an as needed basis.
Management information
Registered date
| 2020 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044607
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