Meeting recruiting goals is always an important factor for clinical trials. But even when the most effective recruiting efforts are not balanced with strategies to engage and retain those patients, it will put the trial results at risk. When patients drop out of a trial, it not only creates data gaps, it skews the overall patient population and can lead to biased results.
Patient attrition has always been a challenge in clinical research, but the use of decentralized clinical trials (DCTs) may help sponsors overcome attrition problems. DCTs allow sponsors to create trial experiences that are less burdensome and more equitable to patients with diverse socioeconomic backgrounds and care needs.
When we combine the use of these models with direct feedback from patients about what would make trial participation a meaningful care option, it can bolster retention and greater engagement between patients, investigators and sponsors.
旅行负担
Research shows that some of the most common causes of attrition in clinical research are time related: specifically, the time required to participate in the trial activities and the time it takes for the participant to travel to the research site.
许多审判参与者到他们的试验网站旅行了25多英里。在某些社区中，距离可能超过双倍的。如果试验需要频繁访问，则会见时间表的时间和成本可能会变得太多。
That quickly erodes recruiting and retention goals. One study of attrition in genomic trials found that enrollment and retention rates decrease by 10 percent for every additional30 milespatients have to travel.
患者体验更复杂或者从治疗中的较少益处也可能更倾向于退出试验，这可以将结果引入数据的结果。增加工作，儿童保育和日常活动的竞争需求 - 特别是对处理医疗条件的患者 - 他们可能会认为试验简单地过于繁重。
DCTs can eliminate many of these burdens by building trials around patients needs. When sponsors incorporate e-diaries and e-consent forms, telehealth visits, and home health staff and local labs into the trial experience, it eliminates the need for excessive travel and reduces the time patients have to invest in the process.
为了充分利用DCT，赞助商需要考虑对审判进行多或更方便的审判的影响，因为参与的患者越来越可观，才能保持致力于结束。
这些决定不仅仅是患者。通过审判参与更容易，更少的繁重，订婚和保留可以在所有患者人口统计学中改进，在更少的时间内产生更强大的数据，并且偏差的风险较低。
对每个人都更好
几项研究探索改善招聘和保留点的方法，以实现虚拟元素的好处 - 例如电子同意，患者电子日记，聊天支持和远程医疗 - 以满足招聘和保留目标。
One 2018 study comparing recruiting and retention rates in conventional vs. DCT trial models in Europe, found that the DCT arm delivered a300% greater rate of enrollment与传统臂相比（89％Vs 69％）相比，较高的保留率明显较高。“该试点的调查结果，当与文献支持技术一起考虑，例如电子知情同意，电子患者报告的结果（EPROS）和远程医疗，以及在远程进行的试验上发表的信息，表明分散的网站模型是一种功能必威官方在线作者结束了，“今天的临床试验中趋势演变的积累。
其他几个报告发现了类似的结果。在前面提到的基因组试验研究中，作者发现使用电话调查为了满足所需的学习活动，而不是让他们前往现场进行最终调查，导致审判结束时的保留率高。
And in a review of cardiovascular disease patients participating in a longitudinal study, researchers found that by offering家庭的后续访问to study participants who couldn’t or wouldn’t come to the site, they were able to keep 61 participants (25% of the enrollees) who would have otherwise dropped out. This eliminated the risk of attrition bias in the data, as the participants requiring home-based follow-ups were more likely to have two or more complications than those who came into the site. The data collected through the follow-up visits enabled them to achieve statistical significance the main trial outcome. “Without home follow-up, the complications sustained by these participants would not have been counted in our study results,” the researchers found.
入门
在Covid-19大流行期间的DCT元素的快速采用，通常实施以缓解场地关闭，可能会导致更多的证据表明积极的影响远程和其他虚拟技术可以对临床试验招募，保留和多样性/包含目标进行临床试验。必威官方在线必威手机APP
Simply put, DCTs make trial participation easier for participants and give them fewer reasons to drop out, which can result in better, faster, and more consistent data. For sponsors struggling with retention issues, offering patients a way to participate in clinical trials from the comfort of their own homes could offer a powerful solution for the future.