A Paradigm Shift in Monitoring Clinical Trials

data_image_handipad_orginal-1What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.

 

A decade ago, the clinical trial industry shunned any notion of conducting clinical trial procedures or trial monitoring activities in any form except in-person and on-site. Fueled by employee demand for a more flexible module of hybrid and remote work, researchers and sponsors are adapting to this new paradigm. The onset of the COVID-19 epidemic forced the industry to abruptly pivot and adapt. Continually evolving technological advances continue to enhance the fields of medicine and clinical research. Although complex in nature, retooling the conduct and clinical monitoring in clinical trials has become imperative.


Study Conduct
What we have seen over the last few years, especially during the pandemic, is that we can conduct a fully robust, and detailed monitoring visit without always needing to be on site. With technological advancement, we can conduct every type of visit remotely. For example, Site Qualification Visit (SQV) 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 commonplace after the onset of COVID-19.


Systems
In 2020, US Food and Drug Administration (FDA) released guidance on Conduct of Trials Medical Products During the COVID-10 Public Health Emergency, then released draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations for public comment in December 2021.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 guidance 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
What we have learned before, 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 the clinical trial development. Although the pivot started before the epidemic, the FDA had suggested a transition to remote monitoring almost 10 years ago (https://www.fda.gov/media/116754/download), but the industry as a whole had been slow to adapt to this recommendation. So, let us look at questions that were answered during the epidemic

  • Does it really take 6-8 hours for an SIV?
    • 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.
  • Can risk-based monitoring be used efficiently?
    • This one is a resounding yes! We are more direct, efficient, and strategic in monitoring and catching any outliers before it.
  • What tasks can be performed virtually?
    • Every monitoring task can be completed remotely. We also have eSource now. This helps both sites upload documents and serves as a channel for CRAs to review Source Documents remotely.
Heavy reliance on online meeting platforms like Zoom and Teams went up significantly during the epidemic and remains the new normal. Training and meetings can now also be accessed remotely for sites and the monitoring team. Now, these platforms do not come without their own headaches, but they have now become an essential part of any clinical trial.