当前位置: 首页 > 期刊 > 《英国医生杂志》 > 2004年第11期 > 正文
编号:11355493
Patient group calls for better understanding of drug trials in the US
http://www.100md.com 《英国医生杂志》
     It is important that the public be engaged at every level of decision making for all clinical research, according to Fran Visco, president of America抯 National Breast Cancer Coalition.

    Ms Visco was speaking at a day long clinical roundtable discussion, organised by the Institute of Medicine on 2 September, to look at how to build public trust in clinical research.

    揟he public needs to understand how the process works and on what basis decisions are made,?she said, adding that this should include resources for educating the public in much the same way that doctors?continuing education is supported.

    Ms Visco outlined how her organisation has built ties with industry, government, and academic researchers to create this mutual trust.

    Patients turn to their peers in choosing treatment options and in deciding whether or not to enter into a clinical trial, she said. But they should also ask whether a trial asking an important question, or was being conducted, she added, 搄ust to keep the infrastructure well oiled.?

    The issue of trust is particularly important in engaging minority communities in clinical trials. Among African-Americans the legacy of the Tuskegee trial, where patients at a college in Alabama with syphilis were followed but not treated for decades after effective treatment became available, remains a significant impediment to enrolling that population.

    Still, anecdotal testimony from invited witnesses and survey data suggests that the greatest reason why more people do not participate in clinical trials is that they simply are not asked or made aware of that option.

    Kenneth A Getz, chairman of the newly formed Center for Information and Study on Clinical Research Participation, said that surveys have found that 65-80% of participants in clinical trials 搘ould definitely do it again if it were appropriate for them.?

    One key factor is doctors. Once they have participated as an investigator in a clinical trial, 搕heir likelihood of referring patients to studies almost doubles,?Getz said.

    A significant portion of those participating in clinical trials in the United States do so as their best or sole means of accessing health care and not for altruistic reasons. Some 44 million Americans are believed to be without basic health insurance coverage while another segment has policies that cap annual or lifetime expenditures on pharmaceuticals or total expenses, making their involvement in drug trials the only way to gain treatment.

    Robert Califf, a doctor at Duke University Medical Center, said this helps to explain why trials that compare drugs A and B are the easiest to enroll. He added that, because many insurance companies refuse to reimburse a doctor for the time taken to explain what was involved by taking part in a trial, doctors often do not even raise the possibility with their patients. Instead, they prefer to stick to the existing standard of care.

    Dr Califf noted, 揙ver the last year, the fairly radical drop out of US investigators , except in some high reimbursement areas.?He said cost issues are leading to the 搊ff-shoring of clinical research,?including up to 70% of the patient population in some trials funded by the National Institutes of Health.

    Participants expressed concern that the recent spate of news coverage of industry payments to some officials at the National Institutes of Health (3 July, p 10) has eroded trust in that organisation and perhaps all of clinical research. They expressed a variety of opinions as to what threshold level of outside income should be publicly reported.(Bob Roehr)