ICH Harmonised Tripartite Guideline E8: General Considerations for Clinical Trials¶
International Council for Harmonisation. (1997). ICH Harmonised Tripartite Guideline E8: General Considerations for Clinical Trials: General Considerations for Clinical Trials.
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Primes¶
- Sandboxing
- Clinical drug trials: phase-I/II trials run a candidate intervention in delimited populations under heavy observation, with stopping rules and explicit graduation criteria — the trial is the sandbox.
This sourceDefines the phased structure of clinical trials, including phase-I/II bounded populations, monitoring, and stopping rules that gate advancement.
Supported in partVerified against the work's full text
ICH E8 states that early-phase trials narrow their populations by strict selection criteria and formally recognises early stopping, backing the delimited-population and stopping elements but not "explicit graduation criteria".
“The variability of groups of patients or healthy volunteers studied in early trials may be lim ited to a narrow range by strict selection criteria, but as drug development proceeds, the populations tested should be broadened to reflect the target population.”
- Clinical drug trials: phase-I/II trials run a candidate intervention in delimited populations under heavy observation, with stopping rules and explicit graduation criteria — the trial is the sandbox.
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