The national rates of participation in clinical trials by cancer patients have never been particularly high. The National Cancer Institute states that, ?less than 5 percent of adults diagnosed with cancer each year will get treated through enrollment in a clinical trial.? Naturally this affects our ability to develop new devices, new drugs, and new diagnostic tests and bring them to market as quickly and as cost-efficiently as possible.
However, according to a new study published recently by Al-Refaie et al., the levels of post-surgical enrollment in clinical trials by men and women in California who received surgery as first-line therapy for any form of solid tumor (prostate cancer very definitely included) are doing nothing to help this situation.
Basing their analysis on data from the the 2001?2008 California Cancer Registry, Al-Refaie and his colleagues showed that:
- 1,566/244,528 patients with a solid tumor (0.64 percent) enrolled in clinical trials after first-line surgical treatment of their cancer.
- Black patients were less likely than whites to enroll in trials (0.48 vs 0.67 percent, P < 0.05).
- Older persons (>65 years), people with early stage cancer, and people with lung or gastrointestinal cancers were also less likely to be enrolled in cancer trials.
- Results were consistent when evaluated among only non-breast cancer protocols.
- Black, under-insured, and uninsured patients showed trends toward under-enrollment in clinical trials.
Whether rates this low are only applicable to patients in California who have previously received surgery as a first-line form of treatment for a solid tumor, or whether they are more broadly applicable across the whole of the USA, is not easy to establish. Some states ? such as Delaware ? have been claiming very high rates of enrollment in cancer trials in the past few years. (We have heard that as many as 20 percent of cancer patients in Delaware participate in clinical trials.) Clearly there is room for some improvement in California if that is the case ? or even if the numbers in Delaware are significantly inflated.
The bottom line is that an insufficient number of cancer patients seems to be either aware of or? encouraged to participate in clinical trials. Furthermore, there is significant under-representation by age, by cancer stage, and tumor site.
As a society we need a clinical trials system with a real world perspective. Academic rigor is one thing, but designing and implementing trials that people actually want to participate in is crucial to an efficient clinical trials process. Let?s assume that Delaware is telling the truth, and that 20 percent of all cancer patients in that small state actually do participate in clinical trials. What are they doing right that has escaped the insights of their colleagues in California? After all, we know that enrollment in a clinical trial is actually the appropriate standard of care for large numbers of cancer patients (including some men with prostate cancer after first-line surgery).
Reuters has also commented on this story under the heading ? ?Abysmal? participation in cancer trials.?
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Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment Tagged: | efficiency, enrollment, post-surgery, trials
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