Briggs R, Robinson S, O'Neill D
Centre for Ageing, Neuroscience and the Humanities, Tallaght Hospital, Dublin.
Ir Med J. 2012 Oct;105(9):311-2.
Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the consumer groups in which they will be used. Increased input from geriatricians around the testing and licensing of medicines, and in licensing agencies, would greatly help in this regard. It is both unhelpful for optimal healthcare as well as fundamentally unjust to exclude participants from clinical research based solely on an arbitrary age limit.
尽管老年人是全球医疗保健资源和药物的最大消费者，但最近的国际研究强调了临床试验中老年参与者的代表性不足。这给医生带来了问题，因为临床实践中见到的患者并不代表那些接受过医学治疗和干预试验的患者，我们需要考虑这些试验的结果（包括阴性和阳性）是否适用于这些患者。我们的目的是评估在提交给都柏林教学医院的研究提案中，排除老年人的情况是否普遍。我们审核了2008年7月至2011年7月（含）期间提交给都柏林三一学院（TCD）附属教学医院研究伦理委员会（REC）的所有临床研究提案，记录基于任意设定的年龄上限而排除患者的情况。在所研究的226项相关试验中，31项（13.7%）仅基于任意设定的年龄上限排除参与者。22项（9.8%）相关试验由老年病科医生提交，其中没有一项仅基于年龄排除患者。神经科/精神科提交的试验中有超过50%（22项中的12项）基于年龄上限排除患者。所有试验用作截止标准的平均年龄上限为69.2岁。除此之外，其余大多数试验还包含其他排除标准，尤其是基于认知功能的标准，这进一步限制了老年人的参与。虽然我们发现提交给TCD REC的相当一部分临床试验仍基于任意设定的年龄上限排除患者，但在这个爱尔兰中心，老年人的参与率似乎高于国际试验中的情况。然而，仍有很大的改进空间，需要提高对开发、测试和批准药物必要性的认识，使其反映将使用这些药物的消费群体。老年病科医生在药物测试和批准以及批准机构方面增加投入，将在这方面大有帮助。仅基于任意设定的年龄限制将参与者排除在临床研究之外，对优化医疗保健既无帮助，从根本上讲也不公平。
