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AstraZeneca ltd randomisation codes
Randomisation Codes, supplied by AstraZeneca ltd, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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other:

Article Title: Effect of Dapagliflozin on Cause-Specific Mortality in Patients With Heart Failure Across the Spectrum of Ejection Fraction
Article Snippet: The AstraZeneca (AZ) personnel or delegate generating the randomisation scheme and the Supply Chain Study Management may be able to access the randomisation scheme as appropriate.

Article Title: Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke
Article Snippet: The AstraZeneca personnel or delegate generating the randomisation scheme and the Supply Chain Study Management department may be able to access the randomisation scheme.

Sequencing:

Article Title: Exploring the insulin secretory properties of the PGD 2 -GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients
Article Snippet: If there is a need of a new randomisation code for subject replacement, the site is to contact the relevant representative at AstraZeneca to receive the correct randomisation number with the correct sequence to ensure the blinding of the study. .. If there is a need of a new randomisation code for subject replacement, the site is to contact the relevant representative at AstraZeneca to receive the correct randomisation number with the correct sequence to ensure the blinding of the study. .. A randomisation scheme will be produced by AstraZeneca R & D using the global randomisation system (GRand).

Article Title: Gefitinib for advanced non‐small cell lung cancer
Article Snippet: .. Random sequence generation (selection bias) , Low risk , Quote: "randomly assigned 1:1 according to a randomisation scheme prepared by biostatics group, AstraZeneca" Comment: this was judged as a low risk of bias. .. Allocation concealment (selection bias) , Low risk , Central allocation Comment: this was judged as a low risk of bias.

Article Title: Fulvestrant for hormone-sensitive metastatic breast cancer
Article Snippet: Previous treatment with fulvestrant or any AI, previous endocrine therapy for breast cancer months previously, systemic chemotherapy for advanced breast cancer or as adjuvant therapy within the previous 4 weeks, extensive radiotherapy within previous 4 weeks, oestrogen-replacing treatment within 4 weeks of randomisation, abnormal hepatic function or lab or comorbid medical illnesses that would compromise safety or prevent interpretation of results Sponsored by AstraZeneca. .. Unspecified whether AstraZeneca was involved in the analyses, but unlikely that this would have affected the results of the study Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk Explicitly described as randomised, double-blind, placebo-controlled study with study drugs being randomly allocated, although the method by which randomisation and allocation was performed was not detailed. ..

Selection:

Article Title: Gefitinib for advanced non‐small cell lung cancer
Article Snippet: .. Random sequence generation (selection bias) , Low risk , Quote: "randomly assigned 1:1 according to a randomisation scheme prepared by biostatics group, AstraZeneca" Comment: this was judged as a low risk of bias. .. Allocation concealment (selection bias) , Low risk , Central allocation Comment: this was judged as a low risk of bias.

Article Title: Fulvestrant for hormone-sensitive metastatic breast cancer
Article Snippet: Previous treatment with fulvestrant or any AI, previous endocrine therapy for breast cancer months previously, systemic chemotherapy for advanced breast cancer or as adjuvant therapy within the previous 4 weeks, extensive radiotherapy within previous 4 weeks, oestrogen-replacing treatment within 4 weeks of randomisation, abnormal hepatic function or lab or comorbid medical illnesses that would compromise safety or prevent interpretation of results Sponsored by AstraZeneca. .. Unspecified whether AstraZeneca was involved in the analyses, but unlikely that this would have affected the results of the study Risk of bias Bias Authors’ judgement Support for judgement Random sequence generation (selection bias) Low risk Explicitly described as randomised, double-blind, placebo-controlled study with study drugs being randomly allocated, although the method by which randomisation and allocation was performed was not detailed. ..



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AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

Journal: ERJ Open Research

Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network

doi: 10.1183/23120541.00719-2025

Figure Lengend Snippet: AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

Article Snippet: Randomisation will be done via the centrally controlled, web-based, GCP-compliant randomisation system, Tayside Randomisation System (TRuST), run by the Health Informatics Centre (University of Dundee), with allocation provided via email.

Techniques: Control, Activity Assay, Comparison