An interesting paper in the most recent issue of the Canadian Urological Association Journal has seriously undermined the idea that treating prostate cancer patients in clinical trials at tertiary care centers is necessarily more costly than treating patients with simple standard of care (SOC) methods in the community setting.
The full text of this paper by Jones et al. is available on line. In it, Jones and her colleagues report on a detailed, retrospective analysis of all costs incurred by 118 patients who were eligible for enrollment in 13 different Phase II or III prostate cancer clinical trials carried out (at least in part) at a tertiary care Canadian cancer center between May 2004 and May 2010. The trials included six that were industry sponsored, six that were sponsored by cooperative groups, and one that was initiated by an individual investigator. The 118 patients were made up as follows:
- 59 patients were men who were eligible for and actually participated in one of the trials (Group A)
- 59 patients were men who were eligible for but decided not to participate in one of the trials (Group B), each matched carefully against the individual men who did participate so as to ensure a comparison of “apples to apples” (so to speak)
It should be noted that (although the paper never says this) the 13 trials from which patients were being assessed were all being carried out in men in need of forms of treatment that did not involve first-line surgery or similar first-line treatments.
Seven cost variables were carefully selected and retrospectively assessed for every patient: physician time, nursing time, tests and procedures, diagnostics and imaging, pathology, radiation therapy, and pharmaceuticals.
Now this paper (as with many) does need to be interpreted with caution. It is a relatively small study, and it can be argued that it may not accurately capture all relevant costs (in either the men on trial or the men being treated in the community). However, what it does show is the following:
- There was almost no difference at all (CDN$20) in the overall average cost of treatment between men in Group A (CDN$10,593 ±7,618) compared to Group B (CDN$10,613± 5,743).
- There was a noticeably increase (of CDN$1,314) in the average costs of treatment between men in Group A (CDN$13,810 ± 9,946) compared to Group B (CDN$12,496 ± 7,384) when analysis was restricted to the 42 men who did or did not participate in industry-sponsored trials.
- There was a noticeably decrease (of CDN$757) in the average costs of treatment between men in Group A (CDN$8,815 ± 5,327) compared to Group B (CDN$9,572 ± 4,370) when analysis was restricted to the 76 men who did or did not participate in non-industry-related trials.
We should point out that it makes perfect sense that industry-sponsored trials are more expensive than non-industry-related trials. In the former, data may need to be collected (for regulatory review purposes) that are rarely if ever collected in standard clinical practice. Similarly, in non-industry-related trials, researchers may be constrained by the grant-funding that is available to them and are likely to avoid incurring costs other than those that are absolutely necessary to the conduct of the trial.
The authors are careful to point out that costs incurred in the conduct of certain types of clinical trial will quite certainly be more higher than the costs associated with standard of care at a specific point in time, but this is the first time that The “New” Prostate Cancer InfoLink has ever seen a comparative cost analysis of this type. The authors note in their conclusion that they are already conducting “a larger, multi-tumor group analysis” (i.e., a similar analysis of comparative costs involving a variety of types of cancer).
Studies like this have major implications for the funding of clinical trials. For example, if it costs no more to treat American men with prostate cancer on Medicare in the community setting than it would to enroll them in a clinical trial, then why not seek to enroll as many as possible in clinical trials which might lead to significant improvements in care? If this anaylsis is even partially correct, the overall cost to the US Government and taxpayers would not be significantly different over time.