Numerous studies have revealed that patient care costs in clinical trials are approximately the same costs as care delivered in standard therapy. In many cases, the costs associated with care in a clinical trial can be less than the care delivered in standard therapy, because the third-party payer is not billed for the drug or treatment under investigation.
Several studies specifically focused on the costs of cancer clinical trials have recently been published in highly respected peer-reviewed publications.
- A pilot study conducted by the American Association of Cancer Institutes (AACI) showed that the average medical charges for patients enrolled in clinical trials were less than the charges for patients receiving standard therapy.1
- A December 2001 article, also found that some clinical trials may actually result in lower patient care costs. In cases where trials resulted in modest increases in patient care costs the authors concluded that these costs were justified by the benefits that clinical trials bring about for all patients.2
- The Mayo Clinic has found that the cost of care for patients enrolled in clinical trials is only slightly higher than the cost of patients who received standard therapy.3
- Authors of a study conducted at Kaiser Permanente, found that “Kaiser has been participating in cancer clinical trials without substantial increases in the direct costs of medical care.”4 The cost of medical care for enrollees in clinical trials (with the exception of bone marrow transplant) were no higher than for patients who were on standard therapy.
- The most comprehensive study confirms that patient-care costs associated with cancer clinical trials is only slightly higher compared to treating similar patients outside of trials.5
Some esteemed hospitals and universities have also conducted cost analysis studies.
- A study at The Ohio State University Comprehensive Cancer Center –James Cancer Hospital and Solove Research Institute showed that in many cases it would be cheaper for the insurance provider to allow the patient to participate in a clinical trial. In one such trial, the research sponsor covered the chemotherapy charges, thereby saving the insurance provider over $100,000 over a typical 4 month treatment period.
- A study at Memorial Sloan-Kettering Cancer Center in New York City showed that the overall average cost of treating clinical trial patients was 17% less than treating patients receiving standard care.6
- Karmanos Cancer Center in Detroit concluded in their study that costs for treating advanced lung cancer over a 6-month time period was on average $1400 less for patients enrolled in a clinical trial.7
The Institute of Medicine has also concluded that the cost impact of providing coverage for routine patient care costs is likely to be “quite small.”8 The IOM’s reasoning included:
- The reimbursement costs are limited to the cost of “standard care”, which would be covered if the patient were not enrolled in the trial.8
- Only a small percentage (approximately 20%) of cancer patients are eligible to participate in a clinical trial and very few (approximately 3% of cancer patients and less than 0.5% of Medicare patients) currently enroll. Even if enrollment increased to a full 20 percent, it is unlikely that these numbers will significantly impact overall costs to health plans.8
- Through clinical trials, we will be able to identify ineffective treatments, which could save health plans money and will benefit the nation as a whole.8
- Bennett CL, Stinson TJ, Vogel V et al. Evaluating the financial impact of clinical trials in oncology: Results from a pilot study from the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project. J Clin Oncol 2000;18:2805-10.
- Bennett CL, Adams JR, Knox KS, Kelehan AM, Silver SM, ailes JS. Clinical trials: Are they a good buy? J Clin Oncol 2001;19:4330-9.
- Wagner, JL, Alberts SR, Sloan JA, et al. Incremental costs of enrolling cancer patients in clinical trials:a population-based study. J Natl Cancer Inst 1999;91:847-53
- Fireman BH, Fehrenbacher L. Gruskin EP, Ray GT. Cost of care for patients in cancer clinical trials. J Natl Cancer Inst 2000;92:136-42.
- Goldman DP, Berry SH, McCabe MS, Kilgore ML, Potosky AL, Schoenbaum ML, Schonlau M, Weeks JC, Kaplan R, Excarce JJ. Incremental treatment costs in National Cancer Institute-sponsored clinical trials. JAMA 2003; 289: 2970-76
- Quirk J. Schrag D, Radzyner M, et al. Clinical trial costs are similar to and may be less than standard care and inpatient (InPT) charges at an academic medical center (AMC) are similar to major, minor, and non-teaching hospitals. Proc Am Soc Clin Oncol 2000;19:433a. (abstr 1696).
- Bennett CL, Stinson TJ, Vogel V, et al. Evaluating the financial impact of clinical trials in oncology: Results from a pilot study from the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project. J Clin Oncol 2000;18:2805-10
- Aaron HJ, Gelband H, editors. Extending Medicare reimbursement in clinical trials. Washington, DC: National Academy Press; 2000. p 13.