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Design and analytic concepts for periodontal clinical trials
1Task Force on Design and Analysis, Inc., Lawrenceville, NJ.
Journal of Periodontology
|December 1, 1992
Summary
This biostatistical review covers periodontal clinical trial design and analysis. It addresses key issues like randomization, site-specific data analysis, and intra-subject correlation for robust study outcomes.
Area of Science:
- Biostatistics
- Periodontal Research
- Clinical Trials
Background:
- Periodontal clinical trials present unique design and analysis challenges.
- Biostatistical considerations are crucial for valid and reliable study outcomes.
Purpose of the Study:
- To survey key aspects of periodontal clinical trial design and analysis from a biostatistical viewpoint.
- To provide guidance on addressing common methodological issues in periodontal research.
Main Methods:
- Discussion of design elements including protocol, subject selection, randomization, and trial types (cross-over, split-mouth, parallel-arm).
- Analysis of methods for defining analytic units, handling multiple sites per subject, and employing randomization tests.
- Exploration of interim and subgroup analyses, and multiple comparison issues.
Main Results:
- Feasibility of analyzing site-specific data while accounting for intra-subject correlation demonstrated.
- Highlights the importance of addressing sampling paradigms and quality control.
Conclusions:
- Sound biostatistical design and analysis are essential for successful periodontal clinical trials.
- Accounting for intra-subject correlation is vital when analyzing site-specific periodontal data.
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