[Pharm-policy] Clinical Trials for Cancer

[James Love]

This is a cite from a 1999 paper from the Journal of the National Cancer
Institute, comparing the costs of care in clinical trials to the costs
of treatment outside of trials.  This and related work is part of an
effort to get insurance companies and governments to fund patient
expenses in clinical trials.  The costs were relatively similiar in this
study. 

In 1998 the Administration proposed a three year demonstration project
to permit medicare to pay for up to $750 million in clinical trial
expenses.  http://www.nih.gov/news/pr/jan98/nci-29c.htm

The trials and care in this study involved the Mayo Clinic, and were
quite high, about $46.4 thousand over 5 years for cancer treatments.   
Jamie

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http://www3.oup.co.uk/jnls/list/jnci/hdb/Volume_91/Issue_10/847.html

Journal of the National Cancer Institute, Vol. 91, No. 10, 847-853, May
19, 1999

Incremental Costs of Enrolling Cancer Patients in Clinical Trials: a
Population-Based Study 

Judith L. Wagner, Steven R. Alberts, Jeff A. Sloan, Steven Cha, Jill
Killian, Michael J. O'Connell, Priscilla Van Grevenhof, Jed Lindman,
Christopher G. Chute 

Affiliations of authors: J. L. Wagner, Congressional Budget Office,
Washington, DC; S. R. Alberts, J. A. Sloan, S. Cha, J. Killian, M. J.
O'Connell, P. Van Grevenhof, C. G. Chute, Mayo Clinic, Rochester, MN; J.
Lindman, Western Michigan University, Kalamazoo, MI. 

Correspondence to: Steven R. Alberts, M.D., M.P.H., Division of Medical
Oncology, Mayo Clinic, 200 First St., SW, Rochester, MN 55905.


BACKGROUND: Payment for care provided as part of clinical research has
become less predictable as a result of managed care. Because little is
known at present about how entry into cancer trials affects the cost of
care for cancer patients, we conducted a matched case-control comparison
of the incremental medical costs attributable to participation in cancer
treatment trials. METHODS: Case patients were residents of Olmsted
County, MN, who entered phase II or phase III cancer treatment trials at
the Mayo Clinic from 1988 through 1994. Control patients were patients
who did not enter trials but who were eligible on the basis of tumor
registry matching and medical record review. Sixty-one matched pairs
were followed for up to 5 years after the date of trial entry for case
patients or from an equivalent date for control patients. Hospital,
physician, and ancillary service costs were estimated from a
population-based cost database developed at the Mayo Clinic. RESULTS:
Trial enrollees incurred modestly (no more than 10%) higher costs over
various follow-up periods. The mean cumulative 5-year cost in 1995
inflation-adjusted U.S. dollars among trial enrollees after adjustment
for censoring was $46 424 compared with $44 133 for control patients.
After 1 year, trial enrollee costs were $24 645 compared with $23 964
for control patients. CONCLUSIONS: This study suggests that cancer
chemotherapy trials may not imply budget-breaking costs. Cancer itself
is a high-cost illness. Clinical protocols may add relatively little to
that cost. clinical trial expenses though medicare.  
  
  Jamie



-- 
James Love, Consumer Project on Technology
v. 1.202.387.8030, fax 1.202.234.5176
love@cptech.org, http://www.cptech.org