The Costs of Conducting Clinical Research

Abstract

Based on the results of our mock trial, the time required for nontreatment trial activities is considerable, and the associated costs are substantial.

Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

“…17 More importantly, studies indicate that this compensation is significantly below the cost of conducting clinical trials. An ASCO study 13 published in 2003 and a C-Change study 14 published in 2005 underscore the fact that the actual cost incurred by a site conducting a trial far exceeds NCI reimbursement. The average study cost per enrollee in publicly sponsored trials in the ASCO and C-Change studies was $5,000 to $6,000, indicating the NCI reimburses less than 50% of the actual cost incurred by sites.…”

“…12 Research indicates that the actual cost of conducting trials is much higher than the established per-case rate of $2,000. 13,14 We hypothesized that per-case reimbursement was an influential factor limiting site participation.…”

Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites

“…5 Investigators find value in conducting government-sponsored trials but often find that these trials pay the research site less than the actual cost the site incurs. 6 A strategy used to overcome this barrier is offering trials through private sponsors, such as companies conducting clinical trials related to therapeutic agents, devices, or products related to supportive care. Private sponsors usually provide reimbursement more closely aligned to the site's cost than do government sponsors.…”

Regrowth Concentration Zero (RC0) as Complementary Endpoint Parameter to Evaluate Compound Candidates During Preclinical Drug Development for Cancer Treatment

“…The preclinical phase involves in vitro as well as in vivo research. The entire process is very expensive and time consuming (DiMasi et al, 2003;Emanuel et al, 2003). Commonly, in vitro experiments for determining the antiproliferative effects of a potential antineoplastic drug are done either in cell free systems or in cell lines by means of short term proliferation assays which measure the incorporation of tritiated thymidine or BrDU into DNA or mass cell by colorimetric methods (e.g.…”