Interim analyses and stopping rules in cancer clinical trials
1993

Interim Analyses and Stopping Rules in Cancer Clinical Trials

publication Evidence: moderate

Author Information

Author(s): J. Whitehead

Primary Institution: University of Reading

Hypothesis

How can sample size determination and stopping rules improve the design of cancer clinical trials?

Conclusion

Sequential clinical trials can effectively adjust sample sizes based on emerging data, potentially leading to quicker and more ethical conclusions about treatment efficacy.

Supporting Evidence

  • Sequential methods allow for adjustments in sample size based on treatment efficacy.
  • Stopping rules can prevent patients from receiving ineffective or harmful treatments.
  • Interim analyses can lead to quicker conclusions about treatment effectiveness.

Takeaway

This study talks about how doctors can stop cancer trials early if they see that one treatment is much better than another, which helps keep patients safe.

Methodology

The paper reviews principles of sample size determination and describes the design of sequential trials with interim analyses.

Potential Biases

The reliance on interim analyses may introduce bias if not properly managed.

Limitations

The paper presents only one approach to sequential clinical trials, and the field is subject to ongoing debate among statisticians.

Statistical Information

P-Value

0.05

Statistical Significance

p<0.05

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication