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Clinical DevelopmentLCZ696B CLCZ696BDE01 / NCT02768298A randomized, doubleblind, activecontrolled study to assess the effect of LCZ696 compared with to improve exercise capacity, daily physical activity and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) Statistical Analysis Plan (SAP)Author:Trial Statistician,Document type:SAP DocumentationDocument status:Amendment 1.0Release date:10Feb2020Number of pages:38; Lead Statistician,Property

How to fill out a randomized double-blind active-controlled

How to fill out a randomized double-blind active-controlled

1. Define the research question and objectives.
2. Determine eligibility criteria for participants.
3. Randomly assign participants to either the experimental group or the control group.
4. Ensure that both groups are similar in terms of demographics and other relevant variables.
5. Blinding: Ensure that participants and researchers do not know which group participants belong to during the trial.
6. Administer the experimental treatment to the active group and a placebo or standard treatment to the control group.
7. Monitor participants throughout the study for any adverse effects and outcomes.
8. Collect and analyze data using appropriate statistical methods.
9. Report the findings, highlighting any significant differences between groups.

Who needs a randomized double-blind active-controlled?

1. Researchers conducting clinical trials for new medications or interventions.
2. Pharmaceutical companies aiming to evaluate the efficacy and safety of their products.
3. Healthcare professionals looking to understand the effectiveness of new treatments compared to existing ones.
4. Regulatory agencies that require robust evidence from studies before approving new therapies.

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What is a randomized double-blind active-controlled?

A randomized double-blind active-controlled trial is a type of clinical study where participants are randomly assigned to receive either the experimental treatment or a standard active treatment, without knowing which treatment they receive (double-blind). This approach helps to reduce bias and allows for a fair comparison of the effectiveness and safety of the treatments.

Who is required to file a randomized double-blind active-controlled?

Typically, pharmaceutical companies, biotech firms, or research institutions conducting clinical trials for new drugs or treatments are required to file a randomized double-blind active-controlled study. Regulatory agencies may also require this type of trial to demonstrate the safety and efficacy of a new therapeutic intervention.

How to fill out a randomized double-blind active-controlled?

Filling out documentation for a randomized double-blind active-controlled trial involves providing details about the study design, protocol, participant criteria, randomization methods, blinding techniques, and data collection processes. Researchers must also include information on statistical analysis plans and informed consent procedures.

What is the purpose of a randomized double-blind active-controlled?

The purpose of a randomized double-blind active-controlled trial is to rigorously evaluate the efficacy and safety of new treatments by comparing them to existing standard treatments while minimizing bias and ensuring that neither the participants nor the researchers know who receives which treatment, thereby enhancing the reliability of the study findings.

What information must be reported on a randomized double-blind active-controlled?

Information that must be reported includes the study design, randomization method, participant demographics, details of the interventions, primary and secondary endpoints, statistical analysis methods, safety and efficacy results, and any adverse events observed during the trial.