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This document details a statistical analysis plan for an open-label, multicenter study evaluating the pharmacokinetics, safety, and efficacy of Zamicastat as adjunctive therapy in patients with pulmonary arterial hypertension (PAH). It includes information on study design, objectives, endpoints, analysis sets, and methodologies to be employed during the study.

How to fill out statistical analysis plan

How to fill out statistical analysis plan

1. Define the research question and objectives.
2. Identify the study design (e.g., observational, experimental).
3. Determine the sample size needed for adequate power.
4. Specify the statistical methods to be used for analysis.
5. Outline how data will be collected and managed.
6. Detail any planned subgroup analyses.
7. Describe how to handle missing data.
8. Provide a timeline for analysis and reporting.
9. Ensure compliance with ethical standards and regulations.

Who needs statistical analysis plan?

1. Researchers conducting clinical trials.
2. Statisticians involved in data analysis.
3. Regulatory agencies reviewing study protocols.
4. Organizations requiring a structured analysis for funding.
5. Academic institutions ensuring research integrity.

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What is statistical analysis plan?

A statistical analysis plan (SAP) is a document that outlines the statistical methods and analyses that will be employed to evaluate data in a research study or clinical trial. It serves as a blueprint for the analysis and ensures that the study's objectives are met.

Who is required to file statistical analysis plan?

Typically, researchers, biostatisticians, and clinical trial sponsors are required to file a statistical analysis plan to ensure regulatory compliance and to properly communicate the intended analyses for a study.

How to fill out statistical analysis plan?

To fill out a statistical analysis plan, one should clearly define the study objectives, list the research questions, specify the statistical methods to be used, detail the data management and analysis procedures, and outline the timelines for analysis.

What is the purpose of statistical analysis plan?

The purpose of a statistical analysis plan is to provide a structured approach to data analysis, minimize biases, ensure reproducibility of results, and facilitate the interpretation of findings in a systematic way.

What information must be reported on statistical analysis plan?

The SAP must report the study design, statistical hypotheses, detailed description of the statistical methods, data collection procedures, and a plan for handling missing data, among other relevant details.