What difference does it make to be treated in a clinical trial? A pilot study.
OBJECTIVE
Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease.


METHODS
Retrospective chart review.


METHODS
Oncology outpatient department in a tertiary care hospital.


METHODS
Ninety women 18 to 70 years of age with early-stage breast cancer who were diagnosed in 1990. Fifty-one of the women were treated through clinical trials and 39 were treated outside of clinical trials.


METHODS
Number of blood tests, telephone calls, clinic visits and imaging procedures as well as intensity of chemotherapy and use of radiation therapy. The age of the patient and the stage of disease were important covariates.


RESULTS
After the analysis was controlled for patient age and stage of disease, patients treated through a clinical trial were more likely to receive standard-dose chemotherapy (p = 0.020, 95% confidence interval 1.20 to 200.73) and more frequent blood tests (p < 0.001, 95% confidence interval 1.02 to 1.13) than other patients treated in the clinic.


CONCLUSIONS
Our results provide a plausible mechanism for the observed survival advantage for participants in clinical trials in oncology. Further study is called for. If these results are confirmed, they have important implications for informed consent to participate in clinical trials and for clinical practice.
Weijer
C
C
Clinical Trials Research Group, McGill University, Montreal, Que. WEIJER_C@FALAW.LAN.MCGILL.CA
Freedman
B
B
Fuks
A
A
Robbins
J
J
Shapiro
S
S
Skrutkowska
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000592:standards*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010865:Pilot Projects; D012189:Retrospective Studies; D016896:Treatment Outcome