Evaluation of the Quality of Clinical Trials

临床试验质量评价

• 批准号: 7118565
• 负责人: Benjamin Djulbegovic
• 金额: $ 21.97万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7118565
• 关键词: bias; clinical trials; data collection methodology /evaluation; ethics; health science research analysis /evaluation; health science research support; morals; oncology; publications

Progress in therapeutics and prevention occurs because experimental testing has been feasible due to willingness of humans to enroll in clinical trials, including randomized controlled trials (RCTs). Many advances in oncology have been made through the unprecedented efforts to conduct RCTs by Co-operative groups (COGs), established in 1955 by the NCI (National Cancer Institute). However, if patients are going to accept enrollment into experimental clinical trials, thereby contributing to future advances in the war against cancer, they (and the public) should believe that the RCT system is fair and intact. In particular, the public should be confident that the estimated effects of healthcare interventions in RCTs are reliable, correct, and trustworthy. The first step toward building the public confidence in clinical research is to assure that trials' methodologic quality (defined as the extent to which all aspects of a study's design and conduct protect against systematic bias and random error) is not compromised. Poorly conducted and reported research seriously compromises the integrity of the research process, especially if biased results receive false credibility. The focus of this application is to perform in-depth critical appraisal of the quality of RCTs conducted by the NCI COGs, which, surprisingly, has never been done. The main importance of the quality assessment is that correct interpretation of data related to health outcomes and the effects of a given health care intervention can be masked by the methodological quality. In other words, depending on the assessment of quality of research we may conclude that an effective intervention is ineffective or that a harmful intervention is beneficial. The short-term goal of this proposal is to assess the research integrity of the COG RCTs by evaluating their quality. The long-term goal is to ensure reliable, high-quality research. Assessing the quality of COG research will help correct any identified deficiencies and in turn help preserve and protect the research integrity of the system of COG clinical trials in which the public has invested so much. It is also hoped that public confidence in COG research may further increase, which in turn will enable development of more rapid advances in the war against cancer.

治疗和预防方面的进展是因为实验测试已经可行，因为人类愿意参加临床试验，包括随机对照试验(RCT)。1955年由NCI(国家癌症研究所)建立的合作小组(COGS)在开展随机对照试验方面做出了前所未有的努力，在肿瘤学方面取得了许多进展。然而，如果患者打算接受参加实验性临床试验，从而为未来抗癌战争的进展做出贡献，他们(和公众)应该相信随机对照试验系统是公平和完整的。特别是，公众应该相信，随机对照试验中医疗干预的估计效果是可靠、正确和值得信赖的。建立公众对临床研究的信心的第一步是确保试验的方法学质量(定义为研究设计和实施的所有方面防止系统性偏差和随机错误的程度)。糟糕的研究和报道严重损害了研究过程的完整性，特别是如果有偏见的结果得到虚假的可信度。这项申请的重点是对NCI齿轮进行的随机对照试验的质量进行深入的批判性评估，令人惊讶的是，从来没有这样做过。质量评估的主要重要性是，方法学质量可以掩盖对与健康结果和特定卫生保健干预措施的影响相关的数据的正确解释。换句话说，根据对研究质量的评估，我们可以得出结论，有效的干预是无效的，或者有害的干预是有益的。这项建议的短期目标是通过评估COG随机对照试验的质量来评估其研究的完整性。长期目标是确保可靠、高质量的研究。评估COG研究的质量将有助于纠正任何已发现的缺陷，进而有助于维护和保护COG临床试验系统的研究完整性，公众在该系统中投入了大量资金。还希望公众对COG研究的信心进一步增强，这反过来将使抗癌斗争取得更快的进展。