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Report Claims Clinical Trials Miss Many Populations
Women, elderly, minorities among those routinely excluded or under-represented, researchers say 报告称临床试验遗漏好多人群 研究人员说女性、老年人、少数民族常被排除在外或缺乏体表性
By Alan Mozes
HealthDay Reporter
TUESDAY, April 1 (HealthDay News) -- A new analysis of the American clinical trial process suggests that the system for testing new drugs has routinely excluded or under-represented women, older people, minorities, disabled individuals and rural populations for decades.星期二，四月一号（健康日报 新闻）--一项新的美国临床试验分析报告称近十年来新药试验常常排除或未能代表对女性、老年人、少数民族、残障人员及农村人口。
\"We've got a big problem,\" said Daniel S. Goldberg, chief policy adviser for the report. \"And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with.\"报告的主要政策顾问Daniel S. Goldberg说:”我们有个大问题.它急需去解决.因为我们试着去做到怎样才能使卫生保健的效率提高并使人们更加健康.而实际上我们的临床试验缺乏代表性,它使我们找到证据的质量打折了.”
The report was conducted by the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine in conjunction with the Intercultural Cancer Council, both based in Houston.这个报告是由位于休斯敦的Baylor医学院慢性疾病预防与控制中心与跨文化癌症协会(Intercultural Cancer Council)联合发起的.
Part of a team of more than 300 analysts led by Armin D. Weinberg, Goldberg and his colleagues spent four years conducting an in-depth review of policy positions held by public, private and nonprofit clinical trial sponsors in the United States. Their research was funded by what is described as an \"unrestricted educational grant\" provided by Genentech Inc. 有超过300人的分析研究人员由Armin D Weinberg领导, Goldberg和他的同事花费了4年时间对美国公共、私人及非赢利的发起的临床试验进行了深入的分析研究。这个研究是由Genentech公司的一个叫做“无限制性教育拔款”（ \"unrestricted educational grant\"）资助。
The team noted that about 80,000 clinical trials are conducted in this country each year, and that less than 1 percent of the American population -- 2.3 million men and women -- participate in such trials.这上团队强调说，国家每年进行的80000个临床试验中，还不到美国总人数的1%，特别是在这种试验中，只有2300000人。
Additional trial problems, such as the lack of adequate training for members of institutional review boards, who are legally obligated to assess the structure of a proposed trial, were cited.试验提到的其它问题还有如准许进行试验的对研究人员缺乏有效的训练。
The report also admonished against the wasting of limited resources that results when government institutions and private industry duplicate each other's efforts in conducting trials focused on the same disease or treatment.报告还告诫政府机构与私人公司对同样的疾病或治疗方法的试验重复浪费了有限的资源。
However, it is the continuing absence of specific constituencies in many trial populations that gets the lion's share of the criticism.然而，大多试验人群中特别人群的缺乏是受到批评的主要原因。
The research looked at cancer clinical trials and found that only 25 percent of patients in such trials were over the age of 65. In addition, older people were often excluded from studies focused on Alzheimer's, arthritis and incontinence, the researchers noted.研究者对癌症临床试验观察发现在这些试验中只有25%的人年龄超过65岁。另外，老年人在Alzheimer病、关节炎和失禁的试验研究中还常常排除在外。
As evidence of the problem, Weinberg and his colleagues honed in on a study of clinical trial composition that found that, between 1995 and 1999, blacks, Asian-Pacific Islanders, Hispanics and Native Americans together made up for less than 10 percent of patients included in new cancer drug trials.为了找到这问题的证据，Weinberg和他的同事在研究临床试验的组成中发现，1995到1999年间，黑人、亚太平洋岛民、西班牙裔、美洲土著人在癌症新药临床试验中总共加起来还不到10%。
Under-representation of this sort, they say, leads to results that do not account for a host of factors -- genetic, cultural, racial, religious, linguistic, as well as variables related to age and gender -- that could have a huge impact on how well new drugs do in the real world.这促整理是缺乏代表性的，导致结果并不能代表一些因素-——遗传、文化、种族、语言以及年龄和性别——这将对新药在实际应用中产生很大的影响。
To address these shortcomings, the team proposed nine policy solutions:
为避免这些缺点，这个团队建议下面9个解决方案：
government regulatory changes;政府规化调整；
increased collaboration between government and private industry on clinical trial design;增加政府与私人公司在临床试验设计中的合作；
increased community involvement in patient participation;对参与的病人加强沟通；
scientific journal oversight of patient breakdowns;科学杂志对病人分类监督；
new, specialized training for review boards; 对审查委员会进行新的特别的训练；
reallocation of research funding to avoid duplication and address disparities; 重新分配基金，避免重复和差异；
increased public education;加大对公众的教育；
increased focus on easing the patient participation process; 简化病人参与试验的过程；
guaranteeing insurance coverage for all related costs.保障保险南覆盖所有的相关花费。
\"The bottom line is there has been a lot of discussion and attention paid in recent years to how clinical trials are put together, and, in particular, the need to account for differences in study patient populations,\" said Weinberg. \"And that's the good news. But the bad news is that as a practical matter, it has yet to have a real impact on studies themselves.\" Weinberg说：“好的消息是至少近年来对临床试验怎样进行有很多的讨论与关注，特别是对病人人群研究时要代表不同的差异性。坏的消息报是作为一实际中操作的事，它仍然对研究本身有影响。”
\"And the problem is that many people, when they take a pill, don't realize that it didn't come out of thin air,\" added Weinberg. \"So, we hope that our work will help people appreciate how the process works, and that what we're talking about is the next generation and how we improve the products and type of therapies that we will have in the future.\" Weinberg增加道：“问题是当许多人吃药的时候，他们并没有认识到这药并不是来自于空气，所以我希望我们的工作可以帮助人们了解到底是怎样的一个过程，我们提到的是将来的下一代和怎样提高产品质量及治疗类型。”
Adil Shamoo, a professor of biochemistry and bioethics at the University of Maryland School of Medicine in Baltimore, agreed that trials must ensure proper patient representation. And he stressed that the problem stems from a lack of structural focus, rather than from any lack of potential volunteers.，巴尔的摩的马里兰大学医学院生物化学与生命伦理学教授Adil Shamoo同意试验需确保病人的代表性。他还强调，问题的根源是对结构关注的缺乏而并不是志愿者的缺乏。
\"We have an extremely willing volunteer population in this country, so there is no question that proper trial representation is doable,\" said Shamoo, who is also the co-founder of the nonprofit Citizens for Responsible Care and Research, based in Columbia, Md. \"And medicine is going to be given to millions of different people, so you do need that representation. Otherwise, you can have risks that you won't know about.\" Shamoo，他还是位于马里兰州哥伦比亚的非赢利性的组织公民保健责任与研究（nonprofit Citizens for Responsible Care and Research）的共同创建者，他说：“我们国家有很多志愿者，所以临床试验完全可以做到有代表性。你必需要有代表性，因为药品将用于数百万的不同人群。否则，将有不可预知的危险。”
Other reports released this week buttress the findings of the Baylor team.这周公布的报告也支持Baylor团队的发现。
On Monday, Duke University researchers reported at the American College of Cardiology meeting in Chicago that although more women are being included in clinical cardiology trials, their numbers are still so low that it's questionable whether the results can actually be applied to women. And a commentary in the April issue of The Lancet Oncology stressed that more teens and young adults need to be included in trials of new cancer drugs, because they are currently under-represented.星期一杜克大学的研究人员在芝加哥召开的美国心脏病协会会议上的报告称虽然女性包括在心脏病的临床试验中，但是数目还是非常的少，因此它是否可用于女性还存在疑问。四月份的柳叶刀癌症杂志评论强调新的癌症药品试验还需要更多的青少年和年轻成年人参与，因为现在他们还缺乏代表性。
临床研究的样本缺乏代表性，结论也难以具备临床的可操作性。
其实这很正常，你在国内做个儿童的临床试试？别说样本的代表性，连样本都很难组织到。 |
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发表于 2008-4-13 11:35:52