Department of Oncology, University College London Hospitals Foundation NHS Trust, London, UK; National Cancer Research Institute Teenage and Young Adult Clinical Studies Group, London, UK.
National Cancer Research Institute, London, UK.
Lancet Oncol. 2014 Jul;15(8):e341-50. doi: 10.1016/S1470-2045(14)70113-5.
Under-representation of teenagers and young adults in clinical trials for cancer is acknowledged internationally and might account for the lower survival gains noted for this group. Little research has focused on strategies to increase participation of teenagers and young adults in clinical trials. We applied a conceptual framework for barriers to recruitment of under-represented populations to data for cancer clinical trials in teenagers and young adults. We did a systematic analysis of data for clinical trial enrolment in Great Britain over 6 years (2005-10), and reviewed the published work for the origins and scientific rationale of age eligibility criteria in clinical trials for cancer. Our Review revealed little scientific evidence for use of age eligibility criteria in cancer clinical trials. Participation in cancer trials fell as age increased. Between 2005 and 2010, participation rates increased for children and young people aged 0-24 years. The highest increase in participation was for teenagers aged 15-19 years, with smaller improvements in rates for 20-24 year olds. Improvements were related to five key criteria, the five As: available, accessible, aware, appropriate, and acceptable. In studies for which age eligibility criteria were appropriate for inclusion of teenagers or young adults or amended during the study period, participation rates for 15-19 year olds were similar to those for 10-14 year olds. We propose a conceptual model for a strategic approach to improve recruitment of teenagers and younger adults to clinical trials for cancer, with use of the five As, which is applicable worldwide for investigators, regulatory authorities, representatives in industry, policy makers, funders, and health-care professionals.
青少年和青年在癌症临床试验中的代表性不足是国际公认的，这可能是该人群生存率提高较低的原因。很少有研究关注增加青少年和青年参与临床试验的策略。我们将代表性不足人群招募障碍的概念框架应用于青少年和青年癌症临床试验的数据。我们对英国 6 年来（2005-2010 年）的临床试验登记数据进行了系统分析，并对癌症临床试验中年龄资格标准的起源和科学依据的已发表文献进行了审查。我们的综述发现，癌症临床试验中使用年龄资格标准的科学证据很少。随着年龄的增长，参与癌症试验的人数减少。2005 年至 2010 年间，0-24 岁儿童和青少年的参与率有所增加。15-19 岁青少年的参与率增幅最大，20-24 岁青少年的参与率略有提高。改善与五个关键标准有关，即五个 A：可获得、可接近、意识、适当和可接受。在适合纳入青少年或青年或在研究期间修改年龄资格标准的研究中，15-19 岁青少年的参与率与 10-14 岁青少年相似。我们提出了一个概念模型，用于制定一项战略方法，以改善青少年和年轻人参与癌症临床试验的招募工作，使用五个 A，这对于研究人员、监管机构、行业代表、政策制定者、资助者和医疗保健专业人员在全球范围内都是适用的。
