Wright James R, Kowaleski Brenda, Sussman Jonathan
Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
Trials. 2008 Mar 3;9:12. doi: 10.1186/1745-6215-9-12.
What constitutes a "clinical trial" is inconsistently defined in the medical literature. With an initiative by Cancer Care Ontario (CCO) to report institutional clinical trials activity across the province of Ontario, Canada, we sought to investigate the variability in the interpretation of the term by local oncology professionals.
A survey amongst the physicians and nurses at the Juravinski Cancer Centre at Hamilton Health Sciences, Ontario was conducted. The survey included 12 summaries of local clinical research studies, and respondents were asked which they believed represented a clinical trial. Subsequently, they were asked which of the same 12 studies they believed should be labeled as clinical trials when considering separate definitions provided by CCO and by the Ontario Cancer Research Network (OCRN).
A total of 66 (54%) of 123 surveys were completed; 32/46 (70%) by physicians, 21/59 (36%) by primary care nurses, and 13/18 (72%) by clinical trial nurses. Without a standardized definition, all studies, 12/12, were considered to be clinical trials by at least 50% of respondents. When provided with the CCO definition only 6/12 studies were considered to be clinical trials by the majority of respondents, while with the OCRN definition it was 9/12 studies. Studies evaluating natural health products, non-traditional medical interventions, and non-randomized studies with standard interventions consistently ranked the lowest, regardless of the definition used.
Oncology professionals appear to have a broadly inclusive baseline definition of what constitutes a clinical trial. Establishing rigor and consistency in the definition of a clinical trial is important for any program, institutional or jurisdictional based comparisons of clinical trials activity, especially when used as a quality indicator of patient care.
医学文献中对“临床试验”的定义并不一致。安大略癌症护理中心（CCO）发起了一项报告加拿大安大略省各机构临床试验活动的倡议，我们试图调查当地肿瘤学专业人员对该术语解释的差异。
对安大略省汉密尔顿健康科学中心朱拉文斯基癌症中心的医生和护士进行了一项调查。该调查包括12项当地临床研究的摘要，受访者被问及他们认为哪些代表临床试验。随后，当考虑CCO和安大略癌症研究网络（OCRN）提供的不同定义时，他们被问及在这12项研究中他们认为哪些应被标记为临床试验。
123份调查问卷共完成了66份（54%）；医生完成了32/46份（70%），初级护理护士完成了21/59份（36%），临床试验护士完成了13/18份（72%）。在没有标准化定义的情况下，所有12项研究中至少50%的受访者认为它们是临床试验。当仅采用CCO的定义时，大多数受访者认为只有6/12项研究是临床试验，而采用OCRN的定义时，这一数字为9/12项研究。无论使用何种定义，评估天然健康产品、非传统医学干预措施以及采用标准干预措施的非随机研究始终排名最低。
肿瘤学专业人员似乎对构成临床试验的内容有一个广泛包容的基线定义。建立严格且一致的临床试验定义对于任何基于项目、机构或辖区的临床试验活动比较都很重要，尤其是当它被用作患者护理质量指标时。
