Monitoring of Clinical Trials …Adapting to the Paradigm Shift

Work has experienced a major transformation and this shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.

Years ago, it would be had been an abnormality in the clinical trial industry to propose any notion of conducting clinical trial procedures or trial monitoring activities in any form except in-person and on-site. However, employee demand for a more flexible module of hybrid and remote work has got researchers and sponsors adapting to this new paradigm. The onset of the pandemic forced the industry to pivot and adapt abruptly. Continually evolving technological advances continue to enhance the fields of medicine and clinical research. Although complex in nature, it has become essential to rejig the conduct and clinical monitoring in clinical trials.

Conduction of Studies
The pandemic has brought to the fore that we can conduct a fully robust, and detailed monitoring visit without always needing to be on site. With advancements in technology, we can conduct every type of visit remotely. For example, Site Qualification Visit can be performed completely remotely where a site tour can be conducted with the site using a live video feed to show the research facility. While site Initiation Visits were conducted remotely before the pandemic, this became normal after the onset of the pandemic.

Improving Systems
In 2020, the Food and Drug Administration (FDA) released guidance on the Conduct of Trials Medical Products During the COVID-10 Public Health Emergency, then released draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations for public comment in December 2021. This guide provides best practices for how digital health tech can be implemented/used to support data.

These two guidance documents indicate the FDA recognizes that there is a shift in the industry that will most likely be a permanent change and is imperative to create an avenue and guidance to ensure that clinical research and monitoring are adapting to the new demands.

Monitoring
The knowledge we had garnered pre, during, and post-epidemic is that the clinical research industry can pivot at any point in time to meet the demands of society. The epidemic has accelerated the ongoing pivot to remote clinical trial monitoring, where remote site access and remote monitoring programs are now the new standards and crucial parts of clinical trial development. Although the pivot started before the epidemic, the industry as a whole had been slow to adapt to recommendations from the FDA to transit to remote monitoring. So, let us look at questions that were answered during the epidemic;

• Does SIV necessarily 8+ hours for a Site Initiation Visit?
  • With the shift in focus and methodology, we have discovered that Visits such as Site Qualification Visits and Site Initiation Visits do not need to be long as we have all been used to. These visits are far more efficient than before.
• Is it possible to have risk-based monitoring used efficiently?
  • Absolutely yes. It is more direct, efficient, and strategic in monitoring and catching any outliers.
• What tasks can be performed virtually?
  • Every monitoring task can be completed remotely. There are eSources now which helps sites upload documents and serves as a channel for CRAs to review Source Documents remotely.

Dependency on online meeting platforms like Google and Teams went up significantly during the pandemic and remains the new normal. Training and meetings can now also be accessed remotely for sites and the monitoring team. To put in perspective, these platforms do not come without their own concerns, but they have now become an essential part of any clinical trial.