Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: Lessons from the National Cancer Institute Community Clinical Oncology Program experience
Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: Lessons from the National Cancer Institute Community Clinical Oncology Program experience
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DOI：
10.1200/jco.2005.10.728
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发表时间：
2005-09-20
影响因子：
45.3
通讯作者：
Minasian, LM
中科院分区：
文献类型：
--
作者：
Buchanan, DR;White, JD;Minasian, LM
目的：确定社区临床肿瘤学项目（CCOP）中研究者提交的关于癌症症状管理的补充和替代医学（CAM）临床试验的建议中的主要研究设计问题。我们对CCOP提交给国家癌症研究所（NCI）的所有概念和方案的科学评论进行了内容分析以确定在进行旨在评估CAM干预措施用于癌症症状管理的临床试验中的研究挑战。结果：自1998年NCI癌症补充和替代医学办公室成立以来，CCOP研究者提出了总共46项使用CAM干预措施的乳腺癌管理研究，其中20项研究正在进行中，占目前CCOP乳腺癌管理组合总数的22%。提案分为四类：复杂的天然产品;营养疗法;身心干预;和替代医疗系统。最重要的研究设计问题是由于缺乏CAM干预的临床前数据以及缺乏与监管新药物制剂所用的质量控制标准相当的质量控制标准。在不同类型的CAM干预措施中，在拟议的研究设计中发现的最常见问题与CAM干预措施的一致性和标准化的无根据假设有关，需要对研究假设进行基于数据的论证，以及需要在试验过程中实施适当的质量控制和监测程序。为了推进科学的发展，未来的研究必须解决这些关键问题，如果CAM干预措施要进行严格的评估，并对临床实践和公众意识产生影响。
Purpose: To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management.Methods: We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management.Results: Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents.Conclusion: Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.