实现招聘目标始终是临床试验的重要因素。但是，即使最有效的招聘工作与参与和保留这些患者的策略没有平衡，这也将使试验结果处于危险之中。当患者退出试验时，它不仅会产生数据差距，而且会偏向整个患者人群，并可能导致偏见。
在临床研究中，患者流失始终是一个挑战，但是使用分散的临床试验（DCT）可能会帮助赞助商克服流失问题。DCT允许赞助商创造出对具有不同社会经济背景和护理需求的患者的繁重且更公平的试验体验。
当我们将这些模型的使用与患者直接反馈有关使试验参与成为有意义的护理选择的直接反馈时，它可以增强保留率并在患者，研究人员和赞助商之间进行更多的参与。
Travel burden
研究表明，临床研究中一些最常见的流失原因与时间有关：具体来说，参加试验活动所需的时间以及参与者前往研究站点所需的时间。
Many trial participants travel more than 25 miles to their trial sites. And in some communities that distance can be more thandouble。If a trial requires frequent visits, the time and cost of meeting that schedule can become too much to continue.
这很快侵蚀了招聘和保留目标。一项基因组试验中的损耗研究发现，每增加一次的入学率和保留率都会下降10％30英里患者必须旅行。
Patients experiencingmore complicationsor fewer benefits from a treatment may also be more inclined to drop out of a trial, which can introduce outcomes bias to the data. Add in competing demands from work, childcare, and day-to-day activities – particularly for patients dealing with a medical condition – and they may view the trial as simply too burdensome to complete.
DCT可以通过建立围绕患者需求的试验来消除许多这些负担。当赞助商纳入电子餐厅和电子甜餐，远程医疗访问以及家庭健康人员和本地实验室的审判经验时，它消除了过度旅行的需求，并减少了患者必威手机APP必须投资这一过程的时间。
To make the most of DCTs, sponsors need to consider what impact trial design decisions have on making a trial more or less convenient, because the more convenient it is to participate the more likely patients are to stay committed until the end.
These decisions don’t just benefit patients. By making trial participation easier and less burdensome, engagement and retention can improve among all patient demographics, resulting in more robust data in less time, and with a lower risk of bias.
Better for everyone
Several studies exploring methods to improve recruiting and retention point to the benefits of virtual elements – such as electronic consent, patient e-diaries, chat support and telemedicine – to meet recruiting and retention goals.
一项2018年的一项研究比较了欧洲传统与DCT试验模型中的招聘和保留率，发现DCT臂提供了一个入学率更高300％, and a significantly higher rate of retention compared to the conventional arm (89% vs 69%). “The findings of this pilot, when considered together with the literature supporting technologies such as electronic informed consent, electronic patient reported outcomes (ePROs) and telemedicine, as well as information published on trials conducted remotely, demonstrate that the decentralized site model is a functional buildup of the evolution of trends seen in clinical trials today,” the authors conclude.
Several other reports found similar results. In the genomic trial study mentioned earlier, the authors found that usingtelephone surveysto fulfill required study activities, rather than making them travel to the site for the final survey, led to high rates of retention at the end of the trial.
在对参加纵向研究的心血管疾病患者的综述中，研究人员发现，通过提供home-based follow-up visits为了学习无法或不会来该网站的参与者，他们能够保留61名参与者（25％的参与者），否则他们会退出。这消除了数据中流失偏见的风险，因为与进入现场的参与者相比，需要家庭随访的参与者更有可能患有两个或更多的并发症。通过后续访问收集的数据使他们能够达到主要试验结果的统计显着性。研究人员发现：“没有家庭随访，这些参与者所承受的并发症将不计入我们的研究结果中。”
Getting started
The rapid adoption of DCT elements during the COVID-19 pandemic, often implemented to mitigate site closures, will likely lead to more evidence showing the positive impact telehealth and other virtual technologies can have on clinical trials recruiting, retention, and diversity/inclusion goals.
简而言之，DCT使参与者的试用参与更加容易，并给他们辍学的理由更少，这可能会导致更好，更快，更一致的数据。对于在保留问题上挣扎的赞助商，为患者提供一种从自己家中舒适的临床试验的方式，可以为未来提供有力的解决方案。