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Pfizer Inc randomisation schedule
Randomisation Schedule, supplied by Pfizer Inc, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/randomisation+schedule/randomisation+schedule/10__1002_slash_14651858__cd003781__pub3-3026-38-47
Average 86 stars, based on 1 article reviews
randomisation schedule - by Bioz Stars, 2026-10
86/100 stars

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Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: .. We judged two studies to be high risk of bias as "the randomisation schedule was generated, secured, distributed, and stored by Pfizer Global Clinical Data Services", the funder of the studies, raising concerns about independence (Dmochowski 2010; DuBeau 2014). ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed and stored by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Unclear risk Double-blinded, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated Incomplete outcome data (attrition bias) All outcomes Unclear risk Dropout rates similar between groups but reasons not stated Selective reporting (reporting bias) Unclear risk Not enough information Other bias Low risk The study appears to be free of other sources of bias Dmochowski 2010 (Continued) Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults (Review) Copyright © 2023 The Cochrane Collaboration. ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: .. Our decision to rate ‘allocation concealment’ as high risk of bias in the studies that involved conflict of interest was based on the fact that the randomisation schedule was generated, secured, distributed and stored by Pfizer Global Clinical Data Services, and that no more information was provided regarding this domain. ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed, and stored, by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Low risk Double-blind, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts are explained and the methods for managing missing data were clearly described Selective reporting (reporting bias) Low risk All prespecified outcomes are reported Other bias Low risk The study appears to be free of other sources of bias DuBeau 2014 (Continued) ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: .. Cochrane Database of Systematic Reviews Allocation concealment (selection bias) Low risk Pfizer generated and secured the randomisation schedule Blinding of participants and personnel (performance bias) All outcomes Low risk Quote: "Neither the investigators nor the participants were aware of the treatment identity" Blinding of outcome assessment (detection bias) All outcomes Low risk Patient-reported outcomes were assessed via bladder diary etc. and participants were unaware of treatment identity Incomplete outcome data (attrition bias) All outcomes Low risk Similar number of withdrawals (82 in anticholinergic group and 74 in placebo); ITT analysis used Selective reporting (reporting bias) Low risk All prespecified outcomes reported Other bias Low risk No evidence of any sources of additional bias Wagg 2013a (Continued) ..

Sequencing:

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed and stored by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Unclear risk Double-blinded, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated Incomplete outcome data (attrition bias) All outcomes Unclear risk Dropout rates similar between groups but reasons not stated Selective reporting (reporting bias) Unclear risk Not enough information Other bias Low risk The study appears to be free of other sources of bias Dmochowski 2010 (Continued) Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults (Review) Copyright © 2023 The Cochrane Collaboration. ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed, and stored, by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Low risk Double-blind, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts are explained and the methods for managing missing data were clearly described Selective reporting (reporting bias) Low risk All prespecified outcomes are reported Other bias Low risk The study appears to be free of other sources of bias DuBeau 2014 (Continued) ..

Selection:

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews Group II (n = 448): fesoterodine 4 mg once daily per oral, could choose to increase to 8 mg at the end of 2 weeks Placebo run-in for 2 weeks Treatment for 12 weeks Outcomes Change from baseline in the mean number of micturitions per 24 hours Bladder diary variables Quality of life using OAB-q Proportion of patients reporting improvement on PPBC and Urgency Perception Scale (UPS); PPBC: ≥ 2-point improvement, 1 point improvement, no change or deterioration from baseline UPS: improvement, no change, deterioration) Percentage change for bladder diary variables Adverse events, BP and heart rate Study funding sources Study funded by Pfizer Notes 116 dropouts (Group I: 60, Group II: 56) Last observation carried forward for missing values; ITT principle used Standard error converted to standard deviation OAB-q data, urgency episodes and UUI episodes per 24 hours were not useable as reported as least square mean change with no standard deviation .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Randomisation implemented using central system accessed by phone or internet that generated single participant identification and randomisation numbers Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed and stored by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Unclear risk Double-blinded, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated Incomplete outcome data (attrition bias) All outcomes Unclear risk Dropout rates similar between groups but reasons not stated Selective reporting (reporting bias) Unclear risk Not enough information Other bias Low risk The study appears to be free of other sources of bias Dmochowski 2010 (Continued) Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults (Review) Copyright © 2023 The Cochrane Collaboration. ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: Cochrane Database of Systematic Reviews 12-week study period Outcomes Primary outcome: change from baseline in urge urinary incontinence at week 12 Secondary outcomes: change from baseline in the number of micturitions per day, and urgency episodes per day PPBC and Urgency Perception Scale Change in QoL evaluated by OAB-q questionnaire Urinary diary activity assessment, questionnaire to evaluate QoL at week 0, 4 and 12 Adverse events, vital signs and PVR Study funding sources Study supported by Pfizer Notes — .. Bias Authors' judgement Support for judgement Random sequence generation (selection bias) Low risk Centralised randomisation system, generated, secured and distributed by Pfizer Global Clinical Data Services Allocation concealment (selection bias) High risk The randomisation schedule was generated, secured, distributed, and stored, by Pfizer Global Clinical Data Services Blinding of participants and personnel (performance bias) All outcomes Low risk Double-blind, but blinding not described Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information Incomplete outcome data (attrition bias) All outcomes Low risk Dropouts are explained and the methods for managing missing data were clearly described Selective reporting (reporting bias) Low risk All prespecified outcomes are reported Other bias Low risk The study appears to be free of other sources of bias DuBeau 2014 (Continued) ..

Article Title: Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults
Article Snippet: .. Cochrane Database of Systematic Reviews Allocation concealment (selection bias) Low risk Pfizer generated and secured the randomisation schedule Blinding of participants and personnel (performance bias) All outcomes Low risk Quote: "Neither the investigators nor the participants were aware of the treatment identity" Blinding of outcome assessment (detection bias) All outcomes Low risk Patient-reported outcomes were assessed via bladder diary etc. and participants were unaware of treatment identity Incomplete outcome data (attrition bias) All outcomes Low risk Similar number of withdrawals (82 in anticholinergic group and 74 in placebo); ITT analysis used Selective reporting (reporting bias) Low risk All prespecified outcomes reported Other bias Low risk No evidence of any sources of additional bias Wagg 2013a (Continued) ..



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Image Search Results


CONSORT 2025 checklist of information to include when reporting a randomised trial

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: CONSORT 2025 checklist of information to include when reporting a randomised trial

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques: Sequencing, Generated, Blocking Assay

Items to include when reporting a randomised trial in a journal abstract

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: Items to include when reporting a randomised trial in a journal abstract

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques: Generated

Five core elements of a defined outcome with examples

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: Five core elements of a defined outcome with examples

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques:

Steps in a typical  randomisation  process

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: Steps in a typical randomisation process

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques: Sequencing

Information required to document the flow of participants through each stage of a randomised trial for the primary outcome

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: Information required to document the flow of participants through each stage of a randomised trial for the primary outcome

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques:

Example of good reporting: Treatments after  randomisation  in patients in an intention-to-treat population

Journal: The BMJ

Article Title: CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

doi: 10.1136/bmj-2024-081124

Figure Lengend Snippet: Example of good reporting: Treatments after randomisation in patients in an intention-to-treat population

Article Snippet: The allocation sequence number is recorded by the research team on the data collection form (DCF), the database and in the participant’s medical record.” “LabCorp Drug Development (a subcontractor to the IWRS [interactive web response system] vendor) generated the live randomisation schedules.

Techniques: