Are Virtual Trials the new normal?
Virtual clinical trials, also called VCTs, are not a new concept, but have experienced a boost during COVID-19. The pandemic has pushed Pharma companies to increase adoption of virtual trials, as patients feel insecure when visiting sites. In addition, regulatory authorities are supporting the initiatives and commit to virtual trials as a result of this.
Reap the benefits of virtual trials
Running your trial as a partly or fully virtual trial enables patients to have much fewer site visits and thereby expands the geographical reach of your trial. This should in turn increase your enrolment rates and decrease drop-out rates.
A virtual trial can also reduce the patient burden in more ways than reducing travel time by including online social engagement platforms to ensure frequent patient contact. This makes patients feel more secure in the trial and again decreases drop-out rates.
During the trial, the increased tracking capabilities and the ability to get real-time information on data collection can be used to send reminders to the patient device to answer questionnaires or conduct their measurements. This increases adherence and data compliance and enables faster database lock.
Considerations
The benefits of virtual trials are easy to spot and explain and make for a great business case… on paper. However, not all trials are made equal and not all trials are fit to be virtualized. If you choose the wrong trial, instead of reaping all the benefits described above, you end up with a lower success rate than if you had gone with a conventional trial setup.
Even when you have identified an eligible trial, making sure that the setup does not increase patient burden is paramount. The type and number of devices and assessments play an important role in the patient’s perception of the trial, and you can be sure that if you increase the patient burden, the drop-out rates will increase as well.
The biggest challenge is to balance the patient burden with the best solution for the trial while keeping the costs in mind. There is no upper limit to the resources a virtual trial can absorb, which is why a firm business case is needed for every virtual trial setup.
Is your Trial ready to go Virtual? Download our white paper about the 5 most common pitfalls when going virtual
Selecting the tools for virtual trials
As Pharma has adopted virtual trials, so have the IT vendors. Many of the usual suspects within the area of clinical systems now offer systems that can form part of a virtual trial. Some vendors even offer a whole platform that includes all the components needed.
Many solutions targeting virtual trials have emerged since the onset of COVID-19 and one should assess the solutions carefully before selection. This also means that many of the solutions are new and will inevitably have some gaps that one needs to be aware of before entering into an agreement. By having a structured vendor selection process, surprises during the Trial Development can be avoided.
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Are you ready to get the most out of your trial?
We have extensive experience with analyzing trial protocols and optimizing the protocol to fit the requirements of a virtual trial and vice versa. Based on the optimized protocol, a vendor selection of the best platform for your trials should me made ensuring faster enrollment and ultimately bringing products to market faster.
We can assist you by combining a proven Life Science specific project methodology with a “best-in-class” knowledge of the trial execution area.
Allan Bech Thomsen
Project Director
Allan is a high-performance senior project manager, specializing in Program/Project Management, Program/Project Execution, Change Management, Business & IT Strategy Alignment, and Financial Management. Allan has been working in the Information Technology space for the last 30 years with deep involvement in the Trial Execution space for the past 8 years.