UMIN-CTR Clinical Trial

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
Email	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
Email	matt.vassar@okstate.edu

Sponsor
Institute	Oklahoma State University Center for Health Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044607