A Multi-Center Study of the Costs of Enrolling Cancer Patients on Phase II Clinical Trials

James Metz, MD
OncoLink Associate Editor
Last Modified: May 20, 2000

Presenter: T.J. Stinson
Affiliation: Northwestern University


It has long been assumed by health insurance companies that clinical trial costs are much larger than those incurred in standard practice. For this reason, both medicare and private insurers have not reimbursed charges for patients in clinical trials. Only 3-8% of adult cancer participants are on clinical trials. This trial was performed to compare the costs of enrolling patients on Phase II clinical trials to the costs of standard medical care.

Materials and Methods:

  • Total direct medical charges for 35 case patients who received care on Phase II clinical trials were tabulated for 6 months.
  • A control group of 35 matched controls also had the medical charges tabulated over 6 months.
  • Charge data was obtained for hospital and ancillary services from automated claims files.
  • The patient population consisted of persons with breast (n=24), lung (n=18), colon (n=16), prostate (n=4), and lymphoma (n=8).
  • The mean charges for 6 months of treatment were $57,542 for clinical trials patients and $63,721 for control patients.
  • This difference was not statistically significant (p=0.42).
Authors' Conclusions
  • This study suggests that the costs of treating cancer patients on clinical trials are not higher than standard treatment.
  • This pilot study will be presented to Congress to gain support for additional studies on this subject..
Clinical/Scientific Implications:

This pilot study provides evidence to counter the assumption that clinical trials are much more expensive than standard medical treatments. Larger studies are needed to confirm the results presented at this meeting