Dec 16, 2020
In the first part of this blog series about Quality by Design, I wrote about how we have seen an increase in the uptake of new technologies by sponsors and clinical research organizations (CROs) to effectively manage clinical trial conduct during the pandemic.
To address and adapt to the changing clinical trial management landscape, sponsors, site management organizations and CROs are maximizing their focus by utilizing a risk-based management approach and incorporating the Quality by Design (QbD) principles as outlined in ICH E6 R2.
Incorporating these principles will help facilitate efficient and effective trial management. And, most importantly, it will ensure that the safety and well-being of patients is prioritized, as well as preserving overall data quality.
There are numerous benefits to clinical trials from this targeted and systematic approach to continuously evaluating risks. Specifically more informed communication among stakeholders. At the end of the day, this approach helps all functional teams throughout the stages of the clinical trial, from patient recruitment, study start-up, study conduct, through to study closeout. And the right technology can help expedite the risk-based study management and monitoring process.
In my previous blog I discussed how risk-based thinking can be broken down into two main aspects: defining what is critical to success for the study and continuously assessing and managing the risks that could derail that success.
Essentially, this requires early detection and visibility into the status of those risks so that sponsors and clinical trial teams can proactively mitigate any negatively trending delta changes.
While the concepts of early detection and visibility sound obvious, these are not new ideas. Metrics and key performance indicators have been around for quite some time now. However, consider the fact that there still exists no way of seeing in real-time what sites are doing. Nor can sponsors or monitors see what documents site personnel are accessing to get them the right information quickly.
Also consider the fact that there are numerous channels to communicate important study related updates, medically related questions, or clarifications for the study teams or medical monitors. The “old ways” still exist when it comes to inefficiencies. This includes the fact that sites are still using paper documents and protocols, that there are multiple communication pathways, and delayed responses to research staff questions due to study teams traveling or important information getting caught up in emails.
These examples demonstrate that there is still room for improvement in the visibility and detectability sector of proactive trial management. Teckro’s digital engagement platform is perfectly positioned to help study teams facilitate the QbD and risk management principles previously mentioned. Teckro offers greater insight into the site behaviors, which could have a direct impact on study trial efficiencies and ultimately, trial outcomes.
Let’s take a deeper dive into how Teckro’s unique features support risk-based monitoring and enable the QbD process:
As the protocol “in your pocket,” Teckro means that the latest trial instruction is always available for research personnel from their mobile device. This eliminates guesswork for research staff by putting the protocol within reach at the point of care. And it helps study teams manage risk because essential study information is readily accessible for those making key decisions, such as participant eligibility and toxicity management.
Stakeholders access current clinical trial information instantly with Teckro Search. The word current is key because we always keep the right, approved version of the protocol for each site. This avoids the risk of protocol deviations or violations because site staff are following the wrong version of the protocol.
But this isn’t merely for the convenience of site staff. Sure, they get the benefit of anywhere, anytime access to the protocol and other study information. However, the benefits are far greater in that sponsors now have the visibility they truly need to understand at a site level what is happening with their trials. What sites are looking at the protocol is a good indication of engagement. And search trends are a critical early indicator of potential safety issues.
Teckro Connect allows site staff to directly access experts for immediate clarification or guidance. This takes the pressure off busy CRAs and means that staff on the ground can confirm the right course of action, making trials more efficient and improving patient safety.
Real-time access to experts also helps time-pressured physicians. As the trusted advisors to patients, they are key to ensuring successful patient recruitment. By unblocking research sites, physicians can quickly and easily confirm decisions, for example patient eligibility.
The combination of Teckro Search and Teckro Connect is powerful from a risk management perspective. It means site staff have not only the access to critical study information when and where they need it, they also have a direct line to ask further clarifying questions – all from their mobile phone. This means questions are answered at the point of care with a patient. Coming back to the QbD principle of continual review, now sponsors have visibility into site staff questions so they can spot trends and be proactive with issues.
Teckro Engage delivers relevant, timely updates to the right people at the right time. While Teckro Connect is a way for site staff to request help, Teckro Engage is the means by which study teams can delivered targeted messages with relevant updates or essential guidance.
Busy monitors and research staff are alerted and can see all of their important study updates in one place through Teckro, rather than wading through emails. From a risk management perspective, having this message history all in one place ensures a seamless chain of communication across study team members so there is a record of messages and when they were sent.
The other benefit of Teckro Engage is that study teams can track whether their messages are opened. We all know that even with the best intentions, emails can slip past us and pile up in our inbox. The Teckro Engage dashboard means study team members don’t have to guess whether their messages are being received.
Teckro Survey is a web-based tool that makes it quick and easy for study teams to get direct feedback from research staff and monitors on the ground.
Risk can be managed with targeted surveys capturing time sensitive site feedback. Study design can be improved by capturing the input from research sites. This way, performance can be improved upon and the site viewpoint included when it comes to determining the feasibility of the next phase of a trial.
Just like with Teckro Engage, study team members have a dashboard to track open and response rates to their surveys. Again, this takes the guesswork out of whether the message is received. Now, study team members have ways between Teckro Engage and Teckro Survey to be super targeted on the messages they want to send and the feedback they collect for continual improvement and risk-based monitoring.
Risk-based study management requires that all study stakeholders take responsibility in order for the trial to be successful. Teckro’s digital engagement platform helps to enable sponsors and clinical research teams “bake in” quality principles from study award through to study closeout.
By evaluating, managing, revising and communicating risks often and defining what is critical to success up front, study teams can expect improved study-related efficiencies, reductions in protocol deviations, and improved communications with study teams and site staff.
Adopting new technologies to meet the new requirements for study management and monitoring doesn’t have to be overly complicated. Optimizing clinical trials using Teckro can help pave the path forward for clinical teams and bring clinical trials firmly into the 21st century.