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Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
Published on: July 27, 2018
Using the NIH Research Methods Resources Website
David M Murray1, Jonathan C Moyer2
1Office of Disease Prevention; Division of Program Coordination, Planning, and Strategic Initiatives; Office of the Director, National Institutes of Health, 6705 Rockledge Boulevard, Room 734B, Bethesda, MD, 20892, USA. david.murray2@nih.gov.
The National Institutes of Health (NIH) Research Methods Resources (RMR) website now offers sample size calculators for five complex clinical trial designs. These tools aid researchers in estimating sample size requirements for various study types.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Health Research Methods
Background:
- The National Institutes of Health (NIH) Research Methods Resources (RMR) website offers guidance on clinical trial design and analysis.
- Information covers randomized controlled trials, individually randomized group-treatment trials, parallel group- or cluster-randomized trials, group- or cluster-stepped wedge trials, and group regression discontinuity designs.
- Existing resources include background information, training links, FAQs, CONSORT/TREND statements, references, and common errors.
Purpose of the Study:
- To address the lack of readily available sample size calculators for complex clinical trial designs beyond randomized controlled trials.
- To provide researchers with accessible tools for estimating sample size requirements for various NIH-supported trial designs.
- To enhance the accuracy and efficiency of sample size calculations in clinical research.
Main Methods:
- Development and implementation of user-friendly, step-by-step sample size calculators for five specific clinical trial designs.
- Calculators are structured as tutorials with adjustable detail levels for novice and experienced users.
- Inclusion of worked examples for design variations (e.g., simple vs. net difference, cross-sectional vs. cohort) with downloadable formulae (PDF).
Main Results:
- Sample size calculators are now available on the RMR website for five complex clinical trial designs.
- Each calculator offers a guided, multi-step process with options for detailed exploration or quick use.
- Worked examples and downloadable formulae are provided to illustrate calculations and support transparency.
Conclusions:
- The new RMR sample size calculators empower researchers to accurately determine sample size needs for diverse clinical trial designs.
- These tools facilitate better planning and resource allocation for NIH-supported studies.
- The RMR website serves as a comprehensive resource for clinical trial design and statistical methodology.
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