Nwaru Bright I, Soyiri Ireneous N, Simpson Colin R, Griffiths Chris, Sheikh Aziz
Asthma UK Centre for Applied Research, Centre for Medical Informatics, Usher Institute of Population Health Sciences and Informatics, Medical School, The University of Edinburgh, Teviot Place, Doorway 3, Edinburgh, EH8 9AG, UK.
School of Health Sciences, University of Tampere, Tampere, Finland.
Trials. 2016 May 26;17(1):264. doi: 10.1186/s13063-016-1381-6.
Randomised clinical trials are the 'gold standard' for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for the recruitment of asthma patients into future asthma trials in the UK. Having set up the database, the goal is to then make it available to support investigators planning asthma clinical trials.
The UK Database of Asthma Research Volunteers will comprise a web-based front-end that interactively allows participant registration, and a back-end that houses the database containing participants' key relevant data. The database will be hosted and maintained at a secure server at the Asthma UK Centre for Applied Research based at The University of Edinburgh. Using a range of invitation strategies, key demographic and clinical data will be collected from those pre-consenting to consider participation in clinical trials. These data will, with consent, in due course, be linkable to other healthcare, social, economic, and genetic datasets. To use the database, asthma investigators will send their eligibility criteria for participant recruitment; eligible participants will then be informed about the new trial and asked if they wish to participate. A steering committee will oversee the running of the database, including approval of usage access. Novel communication strategies will be utilised to engage participants who are recruited into the database in order to avoid attrition as a result of waiting time to participation in a suitable trial, and to minimise the risk of their being approached when already enrolled in a trial.
The value of this database will be whether it proves useful and usable to researchers in facilitating recruitment into clinical trials on asthma and whether patient privacy and data security are protected in meeting this aim.
Successful recruitment is fundamental to the success of a clinical trial. The UK Database of Asthma Research Volunteers, the first of its kind in the context of asthma, presents a novel approach to overcoming recruitment barriers and will facilitate the catalysing of important clinical trials on asthma in the UK.
随机临床试验是评估医疗保健干预措施有效性的“金标准”。然而，成功招募参与者对许多试验人员来说仍然是一项关键挑战。在本文中，我们提出了一个概念框架，用于创建一个基于人群的数字数据库，以便在英国未来的哮喘试验中招募哮喘患者。建立该数据库后，目标是使其可供计划进行哮喘临床试验的研究人员使用。
英国哮喘研究志愿者数据库将包括一个基于网络的前端，用于交互式地允许参与者注册，以及一个后端，用于存储包含参与者关键相关数据的数据库。该数据库将由爱丁堡大学的英国哮喘应用研究中心的安全服务器托管和维护。使用一系列邀请策略，将从那些预先同意考虑参与临床试验的人中收集关键的人口统计学和临床数据。经同意，这些数据将在适当时候与其他医疗、社会、经济和基因数据集相链接。为了使用该数据库，哮喘研究人员将发送他们招募参与者的资格标准；符合条件的参与者随后将被告知新的试验，并被询问是否愿意参与。一个指导委员会将监督数据库的运行，包括批准使用权限。将采用新颖的沟通策略来吸引被招募到数据库中的参与者，以避免因等待参与合适试验的时间而导致的流失，并将他们在已参加试验时被联系的风险降至最低。
该数据库的价值将在于它是否被证明对研究人员在促进哮喘临床试验招募方面有用且可用，以及在实现这一目标时患者隐私和数据安全是否得到保护。
成功招募是临床试验成功的基础。英国哮喘研究志愿者数据库是哮喘领域首个此类数据库，它提出了一种克服招募障碍的新方法，并将促进英国重要哮喘临床试验的开展。
