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Field Testing As Clinical Trial Methodology in Periodontics
Kenneth S Kornman1, Michael G Newman2, Samuel Holtzman3
1Department of Periodontics, The University of Texas Health Science Center at San Antonio, San Antonio, TX, and Department of Periodontology, School of Dental Medicine, Harvard University, Boston, MA.
Journal of Periodontology
|March 15, 2018
Summary
Randomized controlled trials (RCTs) are the gold standard for proving medical treatment efficacy. This review explores evolving field trial methodologies to address current clinical trial needs beyond traditional RCTs.
Area of Science:
- Clinical Trials Methodology
- Evidence-Based Medicine
- Medical Research Design
Background:
- Randomized controlled trials (RCTs) revolutionized medicine, establishing it as a science by providing definitive proof of treatment efficacy.
- Currently, RCTs remain the most trusted method for evaluating therapeutic effectiveness.
- New experimental designs and data analysis techniques are being applied to clinical trials in field settings.
Purpose of the Study:
- To review major trends and developments in field trial methodology.
- To explore current clinical trial needs not adequately met by traditional RCTs.
- To assess the scientific usefulness and considerations for novel trial approaches.
Main Methods:
- Review of evolving experimental designs and data analysis techniques in clinical trials.
- Exploration of field trial settings versus institutional environments.
- Analysis of authors' experiences in field trial methodology.
Main Results:
- RCTs are highly valued for their ability to confidently evaluate therapeutic efficacy.
- Emerging methodologies in field trials aim to enhance understanding of new therapeutic agents and procedures.
- The review addresses the limitations of RCTs and the potential of alternative approaches.
Conclusions:
- Field trial methodology is evolving to meet current clinical research needs.
- Careful consideration of scientific usefulness is crucial for new trial approaches.
- Understanding the strengths and weaknesses of field trials is essential for their effective application.
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