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Analysis of responder-based endpoints: improving power through utilising continuous components.

James Wason^1,2, Martina McMenamin³, Susanna Dodd⁴

¹Population Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Newcastle upon Tyne, NE2 4BN, UK. james.wason@newcastle.ac.uk.

|May 27, 2020

Summary

This summary is machine-generated.

The augmented binary method significantly enhances clinical trial power by utilizing continuous data, applicable to numerous conditions. This statistical approach offers substantial benefits across diverse medical research areas.

Keywords:

Augmented binary method Composite endpoint Efficiency Responder analysis Statistical analysis

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Area of Science:

Biostatistics
Clinical Trial Methodology
Medical Research

Background:

Responder-based endpoints are common in clinical trials, categorizing patients based on thresholds.
These endpoints assess intervention effectiveness by estimating the proportion of responders.
An alternative, the augmented binary method, leverages continuous data for increased statistical power.

Purpose of the Study:

To summarize the augmented binary method.
To investigate its applicability across various clinical conditions.
To identify areas where this method can improve trial efficiency.

Main Methods:

A review of a core outcome sets (COSs) database was conducted.
The review focused on physiological and mortality trial endpoints.
Responder-based endpoints suitable for the augmented binary method were identified.

Main Results:

The augmented binary method is applicable to 67 new clinical areas.
High potential identified in rheumatology (11 disorders), oncology (10), neurology (9), and cardiovascular (8).
This method offers more efficient analysis for specific trial endpoints.

Conclusions:

The augmented binary method offers significant advantages across a wide range of clinical fields.
Further research is needed to refine the method for certain endpoint types.
This statistical approach can enhance the power of clinical trials.