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Notes on the use of historical controls

I Yoshimura¹, K Matsumoto

¹Faculty of Engineering, Science University of Tokyo, Japan.

Environmental Health Perspectives

|January 1, 1994

Summary

Incorporating historical controls in clinical trials requires careful consideration. These historical controls should be treated as a given condition and used conservatively, only when beneficial after evaluating performance.

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Area of Science:

Clinical Trials Methodology
Biostatistics
Epidemiology

Background:

Historical controls are frequently used in clinical research to supplement concurrent control groups.
Specific scenarios necessitate distinct approaches for integrating historical control data.
Conservative utilization of historical controls is paramount to avoid biased results.

Purpose of the Study:

To outline principles and methods for incorporating historical controls in four distinct clinical trial scenarios.
To emphasize the conditional and conservative application of historical control data.
To recommend specific statistical adjustments for different cases.

Main Methods:

Discussion of four cases: stable control (C1), rare responses (C2), small group size (C3), and historical control as reference (C4).
Proposal of adjusting critical values for the Cochran-Armitage trend test in C1.
Application of a modified conditional trend test (Yanagawa et al.) for C2 and conservative use of interblock information for C3.

Main Results:

Historical controls should be viewed as a fixed condition and employed conservatively.
Incorporation is advised only when demonstrably advantageous following conditional performance evaluation.
Specific statistical methods are proposed for C1 and C2, with conservative approaches for C3.

Conclusions:

The judicious incorporation of historical controls can be beneficial but requires careful methodology.
Conservative use and conditional evaluation are key principles for valid application.
Historical controls are not recommended when serving solely as a reference (C4).

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