指南名称:ASCO癌症临床试验临床意义标准指南(2013年)
英文标题:
发布机构:美国临床肿瘤学会(ASCO,American Society of Clinical Oncology)
发布日期:2016-06-08
简要介绍:
发布日期:2013-04-30
英文标题:
制定者:美国临床肿瘤学会
出处:http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=737
内容介绍:
新的ASCO推荐草案对未来胰腺癌、肺癌、乳腺癌以及结肠癌试验中出现所谓“有临床意义的结果”的设定提高了标准。由ASCO肿瘤研究委员会推出的这一推荐草案,有望为会议讨论的每一种癌症研究提供关于总生存期预期最小延长值的标准;期望用于改善获益并指导基于2期试验强大基础的明确的3期试验。ASCO研究委员会充分意识到为“临床试验结局有意义”提供指南和标准是一项“有挑战性的工作”,他们决定工作开始首先选择4种癌症类型。
New draft recommendations from the American Society of Clinical Oncology set the bar higher for clinically meaningful results from future trials on pancreatic, lung, breast, and colon cancers.
Developed by ASCO’s Cancer Research Committee, the draft recommendations are intended to provide an expected minimum increase in overall survival for each cancer discussed; the hope is to improve accrual and guide definitive Phase III trials based on a strong foundation from Phase II trials. Recognizing that providing guidelines and benchmarks for meaningful clinical trial outcomes is a “daunting task,” the ASCO Research Committee decided to start by selecting and focusing on four cancer types.
The recommendations come at a time when ASCO President Sandra M. Swain, MD, Medical Director of the Washington Cancer Institute at MedStar Washington Hospital Center, is calling on Congress to pass a bipartisan bill, HR 1416, which would exempt cancer drugs from sequester budget cuts, cuts that overall could have a chilling effect on cancer research. “More than 120 Members of Congress have signed a letter asking the Secretary [of Health and Human Services] to exercise any authority she has to reverse the cuts and to make it a high priority,” Swain said in a statement. But, she noted, HHS Secretary Kathleen Sebelius has stated that she does not have that authority.
The recommendations on future clinical trial design were developed by working groups convened by the society’s Cancer Research Committee; included were staff from the US Food and Drug Administration and patient advocates. Once public comments on them have been analyzed and consensus has been reached on their final form, they will be submitted to ASCO’s board and then prepared for journal publication, said Lee M. Ellis, MD, Chair of the Cancer Research Committee, lead author on the new recommendations, and Director of the Colorectal Cancer Translational Research Program and Professor of Surgery at the University of Texas MD Anderson Cancer Center.
Ultimate Goal
The ultimate goal, he said, is to work with patient advocacy groups and encourage investigators to design and implement clinical trials using ASCO’s suggested outcomes criteria as benchmarks. He said he plans to participate in an educational session on the draft guidelines at ASCO’s upcoming annual meeting May 31-June 4 in Chicago.
The recommended benchmarks are a response to ASCO’s sweeping November 2011 Accelerating Progress Against Cancer: Blueprint for Transforming Clinical and Translational Research (OT, 12/10/11 issue), which was timed to come out 40 years after President Nixon signed the National Cancer Act in December 1971. The ASCO Blueprint was influenced by the National Cancer Institute’s revitalization of the Clinical Trials Cooperative Group Program and a 2010 Institute of Medicine report, A National Cancer Clinical Trials System for the 21st Century.
ASCO recognized that “cancer science is now in a period of revolutionary change,” said ASCO then-President Michael P. Link, MD, the Lydia J. Lee Professor of Pediatric Cancer at Stanford University School of Medicine, who noted that the molecular era demands new approaches based on cancer biology: smarter, targeted therapy grounded in specific clinical-trial findings. Thus the ASCO Blueprint encouraged smarter, faster clinical trials to provide results in a timely manner targeted to specific patient groups.
Taking into account quality of life, the working groups on meaningful clinical outcomes for the most part agreed that if a therapy is relatively non-toxic, then a smaller improvement in overall survival is acceptable. Although consensus on guideline recommendations was sometimes hard to reach, “nearly all of the working groups agreed that we are in a new era where molecular tools can provide for the identification of new targets that, in turn, will lead to the development of new drugs,” states the draft document.
‘Push the Edge of the Envelope’
The recommendations are just that, and not rules, the committee emphasized. The draft recommendations are intended to “push the edge of the envelope” in an effort to advance cancer care. The document states: “These recommendations must be updated and modified as the current standard of care for each disease evolves.”
Cancer-specific draft recommendations on overall survival follow; a detailed table in the draft document summarizes the recommendations for each cancer discussed.
Praise for Taking the Lead
When ASCO released its report in 2011 on transforming clinical translational research, the IOM’s National Cancer Policy Forum Chair John Mendelsohn, MD, praised ASCO for taking the lead in moving clinical research forward to produce more timely therapies: “What’s important is that this initiative is coming from doctors,” said Mendelsohn, Co-Director of the Khalifa Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center. “In the future, I see more clinical trials that involve an adaptive design.”
Underlying the ASCO Research Committee’s new recommendations is a basic understanding of how cancer research has evolved: “We can no longer view metastasis or unresectable tumors that originate from an organ as homogeneous, and thus treat with one standard regimen,” the recommendations state.
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