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agile clinical monitoring: the flexibility to adapt to study dynamics

Remote, on-site and centralised monitoring - getting the mix right for better outcomes

Travel restrictions and social distancing measures due to COVID-19 significantly disrupted clinical trials, with some drug development companies delaying or postponing their studies following the initial outbreak. Although studies began to reopen mid-year, one analysis by Medidata showed that the enrollment of new participants in trials remains 30 percent below pre-pandemic levels. This unprecedented event has drug developers assessing the way that trials are conducted and accelerating the use of alternative designs and hybrid models to improve study management. 

Even as the pandemic subsides, the use of remote management to increase efficiency is likely to continue to grow as it is adopted into post-COVID clinical trial designs. The agility to adopt the right clinical monitoring has been important to keep trials on track in the challenging environment of a pandemic. COVID-19 has accelerated the thinking on clinical monitoring permanently and may forever change the approach to future clinical trials. 

Pre-pandemic trial designs

Prior to the COVID-19 pandemic, there was an over reliance for Clinical Research Associates (CRAs) to be on site to ensure a study was monitored. This may have been partly due to a very conservative approach to the risk analysis conducted at the outset of the study. On-site monitoring, the more traditional approach, was used in the vast majority of studies and involved the CRA traveling to an investigational site to review and discuss the study conduct; to confirm that patient safety and welfare was protected at the site including the informed consent process, to review storage conditions, allocations and accountability of the investigational drug, to perform source data verification (SDV) and perform source data review (SDR).  

COVID-19 accelerating the shift to remote monitoring 

In response to the restrictions resulting from COVID-19, in March 2020 the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency gave permission to start considering optimising the use of “central and remote monitoring programmes to maintain oversight of clinical sites.” Since that point, the industry increased the amount of remote monitoring with oversight from centralised monitoring. The ability to review trial conduct, real-time data and trend analysis while off-site allows CRAs to focus more on process issues while on-site. 

The future is agile

Implementing a robust and flexible monitoring strategy can increase efficiency and cost-effectiveness  when built into study design at an early stage. For example, assuming a CRA can get full access to the source notes, the cost per off-site monitoring visit could be reduced by approximately 40 percent when accounting for both travel costs and time spent traveling. 

The COVID-19 pandemic has enabled drug developers to embrace the potential of remote monitoring in a way that is likely to carry on into future studies. The use of a well-executed hybrid monitoring strategy is the way forward for companies to remain agile adapting to therapeutic, regional and patient considerations. 

 

For more information on how ICON can help your trial shift to a remote monitoring model, read our whitepaper “Agile Clinical Monitoring: The flexibility to keep your trials on track.”

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