Virtual trials are still relatively new, and in a highly regulated, risk-averse environment, embracing change can be difficult. But the truth is that virtual trials have been supported by regulators and proven to work in many scenarios, which should give stakeholders the confidence they need to get started.
Executing virtual trials is complicated. This isn’t meant to discourage their use but to set appropriate expectations. Clinical trials by their nature are complex, and implementing virtual trials requires much more than simply deploying telemedicine services or giving patients a mobile app. They involve multiple platforms and devices, each of which captures and/or manages a unique data set that will follow its own cadence and construct. All of these platforms and workflows need to be seamlessly integrated and customized to accommodate the idiosyncrasies of that trial’s protocols, patient abilities and investigator needs. The personnel and patients involved in the trial also require training to use these tools while adhering to all rules and industry regulations.
When vetting partners, sponsors should be certain their vendors have enough industry, technological and regulatory expertise to create a virtual trial environment that addresses all of these needs.
Most virtual trials will follow a hybrid model. While a pure, 100 percent virtual trial is the ideal state from a cost-savings and efficiency standpoint, most trials have some on-site visits that can’t be fully eliminated. That’s OK. A hybrid model, which combines some site visits with virtual elements, still delivers time and cost savings while improving the patient experience and gives sponsors a low-risk jumping off point to become familiar with the virtual trial environment.
By 2022, up to 40 percent of new trials may have some (or all) virtual elements, including telemedicine, home health visits and online surveys and questionnaires. By starting small and vetting the validity and reliability of existing virtual technologies, sponsors can gain confidence that future virtual deployments will deliver all of the promised results.
Start early and make “virtual” part of the protocol planning. A virtual trial is about more than just selecting technology. It requires a different way of thinking about how investigators will engage with patients, collect data and demonstrate safety. By making it part of the trial planning process, sponsors ask the right questions from the outset, like how many physicals are really needed, whether endpoint data can be captured at home and whether wearable devices, telemedicine and home health nurses can replace on-site visits. When sponsors wait until after the trial protocol is approved to consider a virtual model option, many of these decisions have to be revisited, which adds costly delays to the process.
Executive sponsorship is key. No matter how much the research team wants to test a virtual trial environment, until executive leadership is on-board, it won’t happen. They make the financial decisions, and they decide how much risk the organization is willing to take. Without their vocal support, others in the organization will be reluctant to engage in a new and unproven clinical research method. The good news is that once they are on-board, experience shows that these trials ramp up quickly, and that these leaders take an active role in engaging with regulators and working with CROs to ensure the deployment is a success.
You need goals that are measurable and meaningful. As with any change-management effort, the only reason to do it is if it will solve a specific business problem or generate better results. There are many business and clinical benefits associated with virtual trials that can be easily measured, including accelerated recruiting, reduced costs and attrition, improved patient engagement and increased quality and quantity of data. All of these benefits help speed drug development and improve revenues. When you begin this journey with a business goal in mind, it becomes easier to win over executives and demonstrate the impact of this transformational approach to research.
No two virtual trials are ever the same. Every clinical trial is unique, whether it’s conducted entirely through on-site visits, in a purely virtual format or somewhere in between. And while every virtual trial will provide sponsors with valuable insights into how to operate in the virtual environment, each new trial design will require a customized, strategic approach. The key is to keep an open mind, to capture lessons learned from the past and to work with partners who have deep technical, clinical and regulatory knowledge to ensure every trial meets the highest expectations for safety, quality, compliance and financial results.