For the last many years, although the virtual clinical trial has found its popularity, sponsors and researchers have always been hesitant to embrace it wholeheartedly for many reasons. However, there has been a drastic change in the clinical trial perception ever since the COVID-19 pandemic has proven to be a universal disruptor in the traditional clinical trial model. The shift in clinical testing regulatory amendments and protocols of clinical trial pharmacovigilance and safety has also been reported.
The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. As a result, the virtual trial is now perceived as a meaningful alternative to the traditional clinical trial method. More so, the traditional method heavily relies on the in-person collection of data at the hospital sites. On the other hand, virtual trials make it possible for patients to stay at home but still participate in the clinical trial process virtually. Technologies like artificial intelligence and clouds are used heavily to seamlessly flow electronic data from the patient to hospitals and research centers.
4 Things to consider before setting up a virtual trial
If you are considering making the shift, here are certain things to ponder upon.
While technologies are available at your disposal, know that the transformation from traditional mode to virtual mode might be challenging. Apart from understanding your organizational capabilities, there are various other factors to consider too.
Is your organization ready for the transformation?
The biggest hurdle for an organization to embrace virtual trial is not technology but understanding the maturity of the organization and its readiness to adopt a new approach.
For example, Johnson & Johnson launched two complete virtual trial programs in 2020. The only way forward for organizations to make this transition is to dissect their entire trial procedure, and analyze each step, and understand the capability requirement and readiness to make this transition. Organizations need to analyze and understand how to document the existing process and workflows, the organization’s vision and determine the stage of readiness.
Understand the impact on stakeholders, especially on patient recruitment and enrolment
A clinical trial involves several stakeholders — patients, hospitals, researchers, sponsors, CROs, etc. Making a shift to a virtual trial will affect different stakeholders differently. Hence, it is important to understand how the change will affect the stakeholder experience. For example, shifting study support from in-person visits to virtual visits might not be a big change for site staff but can drastically change the patient experience.
It is to be noted that while shifting to a virtual model can help address several pain points like patient engagement and recruitment, in some instances, the traditional method is better suited to correctly administer the treatment and measure the outcome using complex machines. For example, while virtual trials can eliminate the limitations due to geographical boundaries, it might be challenging to shift an oncology study in the virtual model.
Understand global regulatory implications
Federal laws and regulations heavily govern clinical trials. It is that sponsors understand the regulatory implications and consider the need for robust pharmacovigilance in the clinical trial study while making the switch.
For example, the regulations for governing trials in the US and EU allow electronic submission of clinical trial reports (with few exceptions), but this might not be the case in other countries. Simultaneously, there are many other activities like submitting informed consent or a trial master file that needs to be transformed into an electronic format from the traditional paper format.
Setting up the infrastructure
After a thorough consideration of all the above factors, sponsors and research organizations need to set up the necessary infrastructure. Investing in centralized platforms, sensors, and wearables make a lot of sense when transforming to virtual trials.
While it is imperative to invest in technology, sponsors also need to ensure enough infrastructure support resources are available. It may sound overwhelming to conduct a virtual trial while providing the right technologies are in place and know that you need not do it all alone. It is always wise to engage with technology companies to collaborate for a better outcome.
Virtual clinical trials have already demonstrated their abilities in clinical trial management. It can reduce participation burdens, reach patients beyond geographical boundaries, manage the robust collection of data set, and more for clinical research companies. It is now with sponsors to analyze and understand their capabilities and readiness to embrace virtual clinical trials.