The costs of conducting clinical research.
OBJECTIVE
Physicians frequently receive payment for enrolling subjects onto clinical trials. Some view these payments as conflicts of interest. Others contend that these payments are necessary reimbursements for conducting clinical research. We evaluated the clinical and nonclinical hours and costs associated with conducting a mock phase III clinical research trial.


METHODS
We collected data from representatives of 21 clinical sites, on the numbers of hours associated with 13 activities necessary to the conduct of clinical research. The hours were based on enrolling 20 patients in a 12-month randomized placebo-controlled trial of a new chemotherapeutic agent. The outcome measures were disease progression and quality-of-life reports. These costs were evaluated for both government and pharmaceutical industry-sponsored trials.


RESULTS
On average, 4,012 hours (range, 1,512 to 13,319 hours) were required for a government-sponsored trial, and 3,998 hours (range: 1735 to 15,699) were required for a pharmaceutical industry-sponsored trial involving 20 subjects with 17 office visits, or approximately 200 hours per subject. Thirty-two percent of the hours were devoted to nonclinical activities, such as institutional review board submission and completion of clinical reporting forms. On average, excluding overhead expenses, it cost slightly more than 6,094 dollars (range, 2,098 dollars to 19,285 dollars) per enrolled subject for an industry-sponsored trial, including 1,999 dollars devoted to nonclinical costs.


CONCLUSIONS
Based on the results of our mock trial, the time required for nontreatment trial activities is considerable, and the associated costs are substantial.
Emanuel
Ezekiel J
EJ
Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Schnipper
Lowell E
LE
Kamin
Deborah Y
DY
Levinson
Jenifer
J
Lichter
Allen S
AS
D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D035843:Biomedical Research / Q000191:economics*; D017326:Clinical Trials, Phase III as Topic / Q000191:economics*; D003365:Costs and Cost Analysis; D017850:Economics, Pharmaceutical; D005380:Financing, Government; D017048:Health Care Costs; D006801:Humans; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000188:drug therapy / Q000191:economics*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000191:economics*
D000970:Antineoplastic Agents; D010919:Placebos