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临床试验:国会关注的需求重点。

Clinical Trials: A Congressional Focus of Need.

作者信息

Coltman CA

机构信息

Cancer Therapy and Research Foundation of South Texas; Southwest Oncology Group, San Antonio, Texas, 78229, USA.

出版信息

Oncologist. 1997;2(4):VII-VIII.

Abstract

Senator Specter, Honorable Members of the Committee, it is my high privilege to speak on behalf of a subject near and dear to my heart. I have been involved in the care of patients with cancer and in cancer clinical trials for the past 34 years. I chair the Southwest Oncology Group, the largest National Cancer Institute-supported cancer clinical research organization. In 1996, this Group enrolled 6,359 patients to therapeutic cancer clinical trials from all 50 states (Fig. 1), and completed the randomization of 18,867 normal, healthy men into the intergroup Prostate Cancer Prevention Trial. Cancer clinical trials are always designed to improve the outcomes of cancer patients. However, only 2%-3% of all eligible cancer patients in this country are treated on these cutting-edge trials. It is clear that this number must increase dramatically in order for us to be able to translate the monumental advances emanating from the basic cancer research laboratories into effective diagnosis, prevention and treatment strategies for patients with and at high risk for cancer. This low accrual is related to multiple factors: First, managed care has had a negative impact related to its refusal to reimburse for the clinical care aspects of patients on cancer clinical trials. During my presentation to the President's Cancer Panel in San Antonio in September, I shared three thoughts as to what the Panel should be asking as they pursue the question of "Managed Care's Role in the War on Cancer": &bul; "Should managed care bear a portion of the costs of clinical research as a form of R & D?" &bul; "What State or Federal legislation is needed to assure that managed care patients have access to cancer clinical research?" &bul; "Will there be any future for cancer clinical research when the managed care tidal wave finally reaches Chicago and New York?" The NCI-Department of Defense and the NCI-Department of Veterans Affairs Interagency Agreements are superb models of what needs to be done for the rest of managed care. Secondly, the Southwest Oncology Group is outstripping its financial support at its current rate of accrual. Even if the managed care problem was resolved, there must be more money to support clinical research to translate this plethora of science to patients with cancer. I am also Director of the San Antonio Cancer Institute, a National Cancer Institute-designated Comprehensive Cancer Center. A recent astonishingly productive Breast Cancer Program Project Grant received a priority score one point below the pay line. While this grant will undoubtedly be funded by exception, it is representative of a nationwide problem of insufficient funds to support truly outstanding research. The following quote is from another Cancer Center Director, who is also a Cooperative Group Chair: "We never know where the next breakthrough will come from. Every time we discover a new gene, we also have a new marker for early diagnosis, a new predictor of response to therapy, a new target for chemoprevention, as well as for cancer treatment. Every discovery in a Cancer Center provides fuel for the Cooperative Group program, and requires affirmation in large clinical trials. Thus, the universe of cancer research is a continuum, (where) improved funding for any of it, impacts all of it, and improved funding for all of it will hasten the pace of discovery throughout." (Richard L. Schilsky, M.D.) Finally, I would like to paraphrase a futurist that I recently heard: &bul; "The present is obsolete." &bul; "The future has already been discovered" in the laboratories of molecular biologists throughout this country! We must search among those discoveries for the keys to cancer cures. &bul; "We are confronted with insurmountable opportunities!" &bul; "These new tools will change the rules of the game!" &bul; "We should not manage change, we should love change and make change our best friend," as all those involved in cancer research and the Congress must do every day. (Don Burrus) Thank you for your attention.

摘要

斯佩克特参议员、委员会各位尊敬的成员,我深感荣幸能代表一个我内心珍视的主题发言。在过去34年里,我一直从事癌症患者的护理工作以及癌症临床试验。我担任西南肿瘤协作组的主席,该协作组是美国国立癌症研究所支持的最大的癌症临床研究组织。1996年,这个协作组从全美50个州招募了6359名患者参与癌症治疗性临床试验(图1),并完成了将18867名正常、健康男性随机纳入组间前列腺癌预防试验的工作。癌症临床试验的目的始终是改善癌症患者的治疗效果。然而,在这个国家,所有符合条件的癌症患者中只有2% - 3%接受这些前沿试验的治疗。显然,为了能够将基础癌症研究实验室取得的巨大进展转化为针对癌症患者及高危人群的有效诊断、预防和治疗策略,这个数字必须大幅提高。如此低的入组率与多种因素有关:首先,管理式医疗产生了负面影响,因为它拒绝为参与癌症临床试验的患者的临床护理方面提供报销。在9月我向总统癌症专题小组在圣安东尼奥的汇报中,我分享了三点想法,关于专题小组在探讨“管理式医疗在抗癌战争中的作用”这一问题时应该提出的问题:• “管理式医疗是否应该承担一部分临床研究成本作为研发的一种形式?”• “需要哪些州或联邦立法来确保管理式医疗的患者能够参与癌症临床研究?”• “当管理式医疗的浪潮最终席卷芝加哥和纽约时,癌症临床研究还会有未来吗?”国立癌症研究所 - 国防部以及国立癌症研究所 - 退伍军人事务部的部门间协议是管理式医疗其他部分所需做法的极佳典范。其次,以目前的入组速度,西南肿瘤协作组的资金支持已不堪重负。即使管理式医疗的问题得到解决,也必须有更多资金来支持临床研究,以便将大量的科学成果转化为癌症患者的治疗方案。我还是圣安东尼奥癌症研究所的所长,该研究所是国立癌症研究所指定的综合癌症中心。最近一个成果惊人的乳腺癌项目资助申请获得的优先分数仅比资助线低一分。虽然这笔资助无疑会破例获得资金,但它代表了全国范围内资金不足这一问题,无法支持真正杰出的研究。下面这段话引自另一位癌症中心主任,他同时也是协作组主席:“我们永远不知道下一个突破会来自哪里。每次我们发现一个新基因,我们就有了一个早期诊断的新标志物、一个治疗反应的新预测指标、一个化学预防以及癌症治疗的新靶点。癌症中心的每一项发现都为协作组项目提供动力,并且需要在大型临床试验中得到验证。因此,癌症研究的领域是一个连续体,(在这个连续体中)对其中任何一部分增加资金投入都会影响到所有部分,而对所有部分增加资金投入将加快整个研究的发现速度。”(医学博士理查德·L·斯基尔斯基)最后,我想套用一位我最近听到的未来学家的话:• “现在已经过时。”• “未来已经在这个国家各地分子生物学家的实验室里被发现了!我们必须在那些发现中寻找治愈癌症的关键。”• “我们面临着难以抗拒的机遇!”• “这些新工具将改变游戏规则!”• “我们不应该应对变化,我们应该热爱变化并让变化成为我们最好的朋友”,正如所有参与癌症研究的人员和国会每天都必须做的那样。(唐·伯勒斯)感谢各位聆听。

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