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She added that many people simply estimate total national trial enrollment by doubling the cooperative group numbers.

As for ascertaining any changes in accrual rates in states with such laws on the books and then comparing them with those of states without such laws, demographic and geographic variables among states would make this unreliable, according to epidemiologists at the ACS.

state laws mandating clinical trial reimbursement-16

We used logistic Poisson regressions to analyze enrollment in National Cancer Institute phase II and phase III Clinical Trials Cooperative Group trials and compared changes in trial enrollment rates between 19 of privately insured cancer patients who resided in the four states that enacted coverage policies in 1999 with enrollment rates in states without such policies. Trial enrollment rates increased in the coverage and noncoverage states by 24.9% (95% confidence interval [CI] = 22.8% to 27.0%) and 28.8% (95% CI = 27.7% to 29.8%) per year, respectively, from 1996 through 2001.Such trials are, in fact, relied upon to produce sound evidence for rational decision making in health care.To generate the most reliable information, clinical trials require certain design characteristics (particularly assignment of participants to interventions by ''randomization"), and they must include enough participants to exclude the play of chance as a likely explanation for results.Recruitment of patients into cancer research studies is exceedingly difficult, particularly for early phase trials.Payer reimbursement policies are a frequently cited barrier.After implementation of the coverage policies in 1999 in four states, there was a 21.7% (95% CI = 3.8% to 42.6%) annual increase in phase II trial enrollment in coverage states, compared with a 15.6% (95% CI = 8.8% to 21.8%) annual decrease in noncoverage states (P A PDF file should load here. If you do not see its contents the file may be temporarily unavailable at the journal website or you do not have a PDF plug-in installed and enabled in your browser. Patients may have specific treatment preferences, based on knowledge of side effects, expense, risk, or inconvenience, that would hamper enrollment efforts.Important sociocultural factors, particularly the legacy of the Tuskegee syphilis study, have led many people to be wary of the motivations of researchers in general As many as 60% of patients who decline participation in clinical trials cite concerns about lack of reimbursement for their routine cancer treatment costs as one of the primary reasons for their lack of participation stated, “Lack of third-party reimbursement for clinical trials may be one of the most critical barriers to patient participation.” Policy makers, in an attempt to improve access of patients to cancer trials, have developed legislative remedies to address these reimbursement concerns.Most often, the effects of an intervention are modest, perhaps a reduction of 10 percent in the risk of an important outcome.Such effects can be extremely important, however, especially when the endpoint is death from some common disease that kills thousands (or tens of thousands) of people each year.Differences of this magnitude cannot be detected reliably against the background of chance and other influences without a carefully planned and controlled study (Hennekens and Buring, 1987).The common image of a clinical trial is the comparison of two (or more) interventions—new versus old (or versus placebo)—to see which one works better.There is no central repository for data on numbers of people participating in clinical trials in each state each year, no mandates for data submission, and no way to track just how many people overall actually participate in cancer clinical trials.Even the American Cancer Society (ACS), whose staff and volunteers have been active in getting these laws passed in various states, does not collect information on the laws’ effects, explained Rachel Tyree, manager of communications and media advocacy of the ACS’s national government relations department.

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