欢迎来到2月2021年的景气版本，由Labcorp分散临床试验博客。
Most of our blogs focus on interesting things we hear from sponsors, new developments at Covance by Labcorp, or interesting challenges we encounter as we partner with sponsors. This month, however, we want to take a look at it more from the patient perspective. The changes of the past year have resulted in a shift in perception on the part of potential participants about their willingness to participate in DCTs.
我们的一名团队成员最近收到了一封电子邮件，提议他们参与移动传感器装置的临床试验。该电子邮件填写了关于如何完全远程的陈述，无旅行，全部在线。不是有点新的，也许有风险，而是作为DCT提供的试验现在是项目的卖点......从所需参与者的角度来看，也许是必要的。由于持续临床试验的80％，其中大部分是“传统的”，由于Covid-19大流行（参考文献1）被中断或甚至停止了，感知的这种转变并不意外。DCT现在在行业中众所周知，这已经陷入了患者人口。此外，随着我们更加习惯于留在家和远离其他人“外面的泡沫之外”，与传统试验相比，提供具有最低现场交互的基于家庭服务的试验。我们从患者中听到的是，我们需要保持高触控护理，高科技方法是实现这一目标的方式。
But let’s back up a bit. Let’s start with where we were when the pandemic was just beginning. Research done in March 2020 (reference 2) showed that more than half of sites expected a negative impact on enrollment and nearly half believed, at the time, that there would be a negative impact on study retention. This was a clarion call that things were going to need to change. Now, a year into the pandemic, we are seeing a much broader acceptance of trials incorporating DCT elements. This comes from both sponsors seeking more resilient trial designs – which also have the potential to speed enrollment – and from the participating patients themselves, who have shown a natural preference for interacting in ways that are both more convenient and less risky. Even sites are increasingly on board and have new tools at their disposal, enabling trial continuity. By last fall, at least 42% of investigator sites reported themselves as being ready to incorporate elements of DCTs into their trials (reference 2), a number which has surely grown since then.
For our part, we have dedicated our organization to developing and promoting patient-centric designs that make the trials not just easier on the sponsors, but that provide a better experience for patients and sites. This transition has been occurring gradually for years, but the pandemic generated a sea change moment in our beliefs, absolutely forcing us to confront the limitations of the old model, creating a willingness about adopting high-tech and high-touch solutions in trials. It’s not optional now – and it’s also not going to be universally adopted for every trial. Sites, sponsors and patients all want these options when it makes sense to make trials easier.
我们正在努力使“新正常”做任何事情，而是正常。相反，我们已经开始了一段循环，我们认为将是一个持续的重新发明的未来的常识。我们期待着与您一起旅行。
参考：
- Dorn，A。V.（2020）。Covid-19和重新调整临床试验。柳叶瓶，396（10250），523-524。DOI：10.1016 / S0140-6736（20）31787-6
- https://myscrs.org/scrs-covid-19-site-preparedness-survey-results/
要了解有关Labcorp如何通过Labcorp的Covance如何帮助您构建DCT的效率，请访问covance.com..
您还可以找到额外的DCT资源，如案例研究，白皮书，科学文章等等www.wfliji.com/dct教育.
