Researchers from Yale University School of Medicine looked at enrollment in cancer clinical trials before and after changes to medical reimbursement policies that were intended to remove some of the economic barriers to clinical trial participation. In two separate reports, the researchers conclude that the removal of these barriers, by itself, is not enough to improve enrollment.
Study 1: Journal of the National Cancer Institute, July 21, 2004 (see journal abstract)
Study 2: Archives of Internal Medicine, July 11, 2005 (see journal abstract)
A National Cancer Institute article on these studies made the following comments:
>Taken together, these studies indicate that insurance coverage barriers are only one factor that limits enrollment in clinical trials. Removing those barriers will not, by itself, improve participation in cancer clinical trials.
>”State mandates and Medicare reimbursement do not appear to be meaningful drivers of patient accrual,” said lead researcher Cary P. Gross, M.D., of Yale University School of Medicine. “Assurance that payers such as third-party insurers and Medicare will cover routine care costs associated with clinical trials is an essential element in improving enrollment rates, but that assurance alone is not a sufficient mechanism for increasing enrollment.”
>”There are numerous barriers to clinical trial enrollment,” said Trimble. “In retrospect, the lack of coverage by Medicare and other third-party payers wasn’t as big of a barrier as we thought.”
>Although the results of these studies are mixed, they do provide important pieces to the puzzle of improving clinical trials enrollment. “The apparent increase in access to early phase studies observed in the JNCI study does show that state legislation can help, just not as much as we had hoped,” said Trimble.