The pandemic drove 45% of clinical trial sites to transition patients from in-person to remote visits using virtual trial solutions.¹ An astounding 83% of all clinical trials are now partially or entirely virtualized,¹ with components taking place and being managed from outside the traditional trial site setting.
While adopting new virtualization technologies introduces new challenges and learning curves, it also creates significant opportunities for all stakeholders. In fact, an estimated 97% of biopharma executives intend to leverage digital technologies in clinical trials over the next three years.²
To alleviate some of the many stressors on patients, sites, and sponsors adjusting to the new virtual clinical trial setting, adoption of the right support services can be a strong complement. Partnering with technology specialists to design, deploy, or outsource virtual trials not only helps accelerate the adoption of virtual capabilities, but also guarantees a virtualization strategy meets compliance and future trial requirements, far beyond COVID-19.
Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.
Designing a Virtualization Strategy against Protocol Development
Determining if a trial can be conducted using a virtual model begins with protocol review. Ideally, key stakeholders, such as the company offering virtualization technologies, will join the sponsor early enough to be involved in protocol development. This ensures that the virtualization methods and potential impacts on sites and patients can be evaluated early on instead of requiring later protocol amendments to include these technologies.
With an estimated 60% of trials experiencing protocol amendments during the trial,³ which impacts timelines and bottom lines, avoiding unnecessary amendments is critical for all stakeholders. The inclusion of experienced virtualization strategists in this early stage can set studies up for an accelerated start and uninterrupted life cycle.
Reviewing protocol and determining which procedures and oversight activities can be managed outside of the traditional trial setting, and which can be virtually accomplished, can be complex and time-consuming. Enlisting experts familiar with enabling virtualization technologies not only relieves that burden, but also enhances their familiarity with the trial, so they can better assist with next steps of operationalizing the identified virtual activities.
Access Medidata's paper on Trial Virtualization here.
Alleviating Patient Burden
While virtualization has had a clear positive impact on patient enrollment, showing improvement up to 81% when using virtual recruitment,⁴ this does not speak to patient retention or experience. Maintaining a patient-centric approach throughout the course of a trial is essential to retention, and virtual clinical trials can be overwhelming for patients unfamiliar with technology, especially when multiple devices, logins, and platforms are involved.
Relying on specialists to customize and optimize a trial design to reflect the best mix of onsite and virtual touchpoints can result in an enhanced experience for the patient. It helps foster consistent behaviors and greater subject satisfaction, thus driving higher retention.
Rather than spending valuable time on research and discovery, at the expense of all areas of the clinical trial, the option of augmenting the trial team with an outsourced specialist well-versed in the trial's technologies and capabilities can expedite startup and ensure its smooth initiation.
Managing through Operational and Compliance Changes Seamlessly
Among the greatest challenges to virtualizing a clinical trial are the operational and process changes that it will require. Many of the world's regulatory agencies have issued guidance documents that describe how new processes and methods can be implemented to protect patients and facilitate continued trial execution while maintaining Good Clinical Research Practice (GCP) standards.⁵
Working with a professional services partner will guide clinical trial teams on how to best implement GCP-compliant standards and processes, providing not only convenience, but also the peace of mind that comes with knowing the clinical trial's seismic shift to full or partial virtualization will meet these stringent and evolving guidelines.
The Expertise to Assure your Virtualization Strategy Success
COVID-19 has accelerated adoption of virtual capabilities as an urgent response. The essential ingredient for optimal performance, growth, and transformation is the adaptive speed that a best-in-class professional service organization will provide support for, from planning to closure; for implementation, from startup to study closeout; for operational excellence, from enablement to knowledge maintenance; and for account oversight, from governance to value attainment.
Leveraging the expertise of a dedicated, digital technology professional services partner can help align, accelerate, and assure new virtual clinical trial processes and objectives meet immediate needs. Foremost, it ensures long-term virtualization capabilities are designed to deliver on patient-centricity, compliance, and future disruptions.
Access Medidata's paper on Trial Virtualization here.
² Everest Group, 2018: “Navigating the Clinical Trial Landscape: Perspective from the Field”
³ Everest Group, 2018: “Navigating the Clinical Trial Landscape: Perspective from the Field”
⁴ Medidata Survey, PT Centricity White Paper
⁵ FDA, 2020a; EMA, 2020; MHRA, 2020; HSA, 2020 Taylor, 2020)