Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment
1989

The Role of Surrogate Patients in Cancer Clinical Trials

Sample size: 400 publication Evidence: moderate

Author Information

Author(s): W.J. Mackillop, M.J. Palmer, B. O'Sullivan, G.K. Ward, R. Steele, G. Dotsikas

Primary Institution: Queen's University

Hypothesis

Can the opinions of expert surrogate patients influence the ethical acceptability of clinical trials?

Conclusion

Lay people often cannot discern the differences in acceptability of clinical trials that are clear to experts.

Supporting Evidence

  • 50% of lay people consented to a surgical trial compared to 64% of expert surrogates.
  • 69% of doctors believed new trials should be evaluated by expert surrogates.
  • After learning doctors' opinions, the consent rate for the chemotherapy trial dropped significantly.

Takeaway

Doctors and lay people were asked if they would join cancer trials, and many lay people didn't understand the risks as well as the doctors did.

Methodology

Surveys were conducted with doctors and lay people regarding their willingness to participate in clinical trials and their understanding of the trials' acceptability.

Potential Biases

Potential bias due to the non-random selection of lay participants and the influence of the framing of questions.

Limitations

The sample of lay people was not a random cross-section of society, which may limit the generalizability of the findings.

Participant Demographics

The survey included 400 lay people, with two-thirds being women, and a mix of ages and educational backgrounds.

Statistical Information

P-Value

p<0.0001

Statistical Significance

p<0.05

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