5 Questions to Ask Your Sponsor for DCT Implementation
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In an effort to keep up with current technological trends, along with both site and participant interest, many sponsors are considering switching to a DCT model by building their own, purchasing, or licensing DCT technology.
Yet, sponsors are still uncertain about how to design a DCT to ensure efficient performance delivery. While there are many things to consider before adopting a DCT platform, asking these five questions beforehand can set your organization up for success.
Could our Trial Lend Itself Well to a DCT Model?
Clinical trials are slow and costly, built around the research centers studying local participants. Building clinical trials around patients in their homes and community through remote visits and monitoring could enhance recruitment and increase convenience for participants. However, before considering moving any trial to a DCT model, it’s important to understand your trial might not properly fit into the DCT model. Certain trials, specifically ones involving focused procedures performed in-clinic or those with significant expected safety events during investigational medicinal product administration, may not be appropriate for a DCT model.
In cases such as those, it’s helpful to get a birds-eye view of all current and future trials for your organization and identify them right away. Knowing which trials may not fall neatly into a DCT model will save your organization time and energy when it comes to making any switches.
Can our Standard Operating Procedures Change?
It’s likely your organization already has standard operating procedures (SOPs) set in place for trial conduct. While these are critical to a smooth trial and can often help research staff find the answers they are looking for, they will need to be adapted to accommodate a DCT model.
However, adapting current SOPs to fit a DCT model is time consuming, and with staff already exceeding bandwidth levels, it may be tempting to forego creating new SOPs. If your team isn’t able to, they run the risk of using poor-quality data, longer timelines, and increased study costs due to reduced ability to monitor and increased competition for site staff availability. In today’s fast-paced trial environment, every second counts; sacrificing data quality and longer timelines may cost sites in future trials.
Could any of our Current Trials Benefit from a DCT Model?
It’s entirely possible for an ongoing trial to lend well to a full or hybrid DCT model. While your team may be able to switch mid-trial to a decentralized model, it’s rare. However, if you have a trial in the enrollment or participant follow-up stages, they may still benefit from your team reviewing a DCT model to identify areas where you could reduce cost and improve data quality.
This may be a strategy your research team can adopt for any trials in the pipeline as well. Being cognizant of upcoming trials challenges team members to analyze them and find ways to reduce costs while improving data quality simultaneously. At the very most, it may help your team members identify which trials could benefit from the DCT model, further strengthening the trial as a whole.
Is our Staff up to Speed on Implementing DCTs?
If there are any current or future trials potentially benefiting from the DCT model, the next thing to do is train your staff on how to implement one. Experienced staff members may be familiar with one way of performing trials, they may not have much exposure to anything else. Implementing comprehensive training sets your staff up for success and gives them a space to become comfortable with a new trial model before anything goes live.
This is also an opportune time for an organization to evaluate and select technology solutions to enhance DCT performance. Picking the right technology to complement your DCTs can often be the difference between staff members not fully understanding how to implement it versus understanding and excelling at this type of trial model.
Can we Quickly Adopt the DCT Platform?
With the right technology in place and staff up to speed on the implementation process, organizations can set timelines for DCT platform adoption. While many organizations and trials demonstrate significant cost and time savings, along with improved data quality, many are still experiencing significant adoption delays. Understanding associated DCT technologies, and performing independent assessments first, are critical to early and efficient adoption. By listening to your experts, your organization is more likely to find success for current and future studies on your DCT platform.