Related Experiment Videos
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
Background:
When assessing a new, promising therapeutic approach, a clinician's perception of a drug's effectiveness may be shaped by different kinds of phenomena, and among them, a favorable attitude towards new treatments, and as a result a tendency to overestimate their efficacy (wish bias).
Materials And Methods:
A retrospective study of published randomized clinical trials of doxorubicin-based chemotherapy for advanced breast cancer was carried out. Global (complete plus partial) response rate over time with allowance for type of drug regimen (mono- or polychemotherapy) and prior adjuvant therapies was assessed in the doxorubicin-containing arm using multivariate logistic regression analysis.
Results:
Twenty-nine studies published from 1975 to 1999 were retrieved for a total of 2234 women with advanced breast cancer enrolled in the doxorubicin-containing arms. There was a significant decrease in response rate to doxorubicin as first-line treatment over time that resisted adjustment for important differences in therapeutic management [odds ratio for global response = 0.89, 95% confidence interval (CI) 0.81 to 0.99].
Conclusions:
Although only one drug (doxorubicin) in one clinical context (advanced breast cancer) has been analyzed, our findings support the use of double blind methodology whenever possible when assessing subjective endpoints and encourage further studies aimed at defining the clinical relevance of a wish bias in medicine.
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.