Does a drug do better when it is new?

R Fossati1, C Confalonieri, G Apolone

  • 1Department of Oncology, M. Negri Institute, Milan, Italy. fossati@marionegri.it

Abstract

Insights

Clinicians may overestimate drug efficacy due to wish bias. A study of doxorubicin chemotherapy for advanced breast cancer found response rates significantly decreased over time, suggesting a need for objective trial methodologies.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Clinician perception of drug efficacy can be influenced by biases, such as wish bias, leading to overestimation of treatment effectiveness.
  • Assessing new therapeutic approaches requires careful consideration of potential psychological influences on perceived outcomes.

Purpose of the Study:

  • To investigate the trend in response rates for doxorubicin-based chemotherapy in advanced breast cancer over time.
  • To assess the impact of wish bias on the evaluation of chemotherapy effectiveness in clinical trials.

Main Methods:

  • Retrospective analysis of 29 randomized clinical trials (1975-1999) involving 2234 women with advanced breast cancer.
  • Multivariate logistic regression was used to assess global response rates in doxorubicin-containing arms, accounting for chemotherapy regimen and prior adjuvant therapies.

Main Results:

  • A significant decrease in the global response rate to doxorubicin as first-line treatment was observed over time (odds ratio = 0.89, 95% CI 0.81-0.99).
  • This decline persisted even after adjusting for variations in therapeutic management.

Conclusions:

  • Findings suggest a potential decline in doxorubicin efficacy for advanced breast cancer over time, independent of treatment modifications.
  • The study supports the use of double-blind methodologies for subjective endpoints to mitigate wish bias.
  • Further research is recommended to explore the clinical relevance of wish bias in medical assessments.

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