Virtual Clinical Trials

The COVID-19 pandemic has forced us to reimagine social interactions from a personal level to a global one. While the pandemic has limited the feasibility of certain options, it has expanded incentives for others. Travel restrictions, site closures, and quarantine requirements, for instance, have made it difficult for companies to perform clinical trials, prompting many to use Virtual Clinical Trials (VCTs) during the pandemic [1]. Although VCTs existed prior to the pandemic, they have grown in popularity as a means of navigating these pandemic restrictions [2].


There are many different types of VCTs but at their core, all VCTs incorporate some form of digital health technology. These integrations range from traditional in vivo trials with a virtual “clinic visit” to fully completely virtual trials where the human subject is replaced with a “virtual digital phantom” or a digital file used to emulate the clinical process without actually conducting a clinical trial [3]. These different trial formats are advantageous in various situations.


Clinical trials, for example, have encountered a wide range of challenges during the COVID-19 pandemic. These include prioritizing patient safety amidst the pandemic, recruiting new research patients, data gathering and management, and intervention delivery. The increased utilization of clinics for COVID care has made it more difficult to conduct the “clinic visits” during a clinical trial. These clinic visits are a key part of the trial, as they are an important part of both safety monitoring and data collection [4]. Thus, virtual clinic visits, which can take place over phone calls, video conferences, or even reporting health metrics in a mobile app, can be extremely useful for companies conducting in vivo trials during the pandemic [4].


However, in other contexts such as medical imaging, completely virtual trials can be beneficial for different reasons. By generating a digital population that undergoes a virtual scanning process, medical imaging device makers can emulate clinical trials at a fraction of the original time and cost [3]. Furthermore, these completely virtual trials can assess the utility of these medical imaging devices while minimizing risks such as exposure to radiation [3].


While VCTs provide companies with greater flexibility when performing trials, they are not without disadvantages. While patient privacy concerns are the most prevalent issue, other barriers such as a lack of access to certain technologies in rural areas and technology failures or shortcomings are all salient concerns with VCTs [4]. Moreover, the human body is more complex than we currently know, and using digital populations in fully simulated trials may struggle to represent this fact and subsequently fail to catch the full range of adverse effects a device has on human subjects [5]. While it is likely that these issues (especially the technological ones) will likely be ameliorated as VCTs become more common, they should nonetheless be important considerations for any organization considering conducting a VCT.


During these difficult times, we have been forced to adapt to a “new normal” in order to comply with pandemic restrictions and ultimately preserve our health. As vaccinations progress and we look forward to a return to the world as we knew it, whether VCTs are a part of this future remains to be seen. Nonetheless, for the time being, we may be in the midst of the golden age for VCTs.


References:

1) “Conduct of Clinical Trials of Medical Products During the COVID19 Public Health Emergency.” Fda.gov, Food and Drug Administration, Mar. 2020, www.fda.gov/media/136238/download.

2) Villa, Yimy. “The Growth of Virtual Clinical Trials during COVID19.” The Stem Cellar, CIRM, 11 June 2020, blog.cirm.ca.gov/2020/06/11/the-growth-of-virtual-clinical-trialsduring-covid-19/.

3) Ehsan Abadi, William P. Segars, Benjamin M. W. Tsui, Paul E. Kinahan, Nick Bottenus, Alejandro F. Frangi, Andrew Maidment, Joseph Lo, Ehsan Samei, "Virtual clinical trials in medical imaging: a review," J. Med. Imag. 7(4) 042805 (11 April 2020) https://doi.org/10.1117/1.JMI.7.4.042805

4) Alper, Joe, et al. Virtual Clinical Trials: Challenges and Opportunities, Proceedings of a Workshop. National Academies Press, 2019.

5) Maidment A.D.A. (2014) Virtual Clinical Trials for the Assessment of Novel Breast Screening Modalities. In: Fujita H., Hara T., Muramatsu C. (eds) Breast Imaging. IWDM 2014. Lecture Notes in Computer Science, vol 8539. Springer, Cham. https://doi.org/10.1007/978-3-319- 07887-8_1

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