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Blockchain systems were first introduced to manage cryptocurrency transactions such as Bitcoin (Maslove et al., 2018). As such, they provide a secure basis for online contracts, wherein participants can sign off on certain actions with another source (Nugent et al., 2016). These systems lend themselves to being applied beyond direct financial exchanges and can serve a role in incentivization programs (Maslove et al., 2018; Shrestha and Vassileva, 2018). When applied to clinical trials, these systems can utilize Blockchain to secure data and increase participant recruitment and/or retention (Benchoufi and Ravaud, 2017). The purpose of this paper is to establish the benefit of using a Blockchain-based incentivization system, in this case, Cashish virtual tokens, to increase participation, retention, and facilitate secure medical data exchange in Virtual Clinical Trials.
Virtual Clinical Trials (VCTs), also called remote or decentralized trials, are a relatively new method of conducting clinical research taking full advantage of technologies such as mobile apps, electronic monitoring devices, and online social engagement platforms (National Academies of Sciences, Engineering, and Medicine (NASEM), 2019). VCTs may overcome the challenges faced in conventional clinical trials wherein it is expensive to recruit even a limited number of suitable participants (Huynh et al., 2014). In traditional clinical trials participants are recruited through hospital visits, medical clinics, or using media such as newspaper/radio/television ads. The reach and ability to participate are often limited by participants’ geography.
The COVID-19 pandemic has invigorated the growth of VCT adoption for both drug development and treatment therapies. VCT tools are creating a new era of speed, efficiency, and transparency to advance clinical studies, supporting the accelerated development of COVID-19 vaccines (van Dorn, 2020). The COVID-19 pandemic is fast-tracking the transition to more virtual approaches for gathering remote clinical data, which facilitates new advances and provide more convenient options for patients participating in studies.
In VCTs a combination of traditional participant recruitment and digital recruitment is used. The combination of recruitment strategies leads to more rapidly reaching the enrollment target resulting in faster initiation of the study (NASEM, 2019). When occuring digitally, participants are targeted directly via web-based platforms, such as search engines and social media. This approach allows for fast recruitment of participants without geographical limitations, reaching eligible trial participants worldwide.
A broader digital recruitment strategy targeting participants across geographical locations results in a more diverse group of study participants. This increasingly diverse pool of participants would mean a higher degree of representation of the real-world than what can be obtained in traditional clinical trials.
Additionally, VCTs have the potential to address issues regarding participant recruitment for research into sensitive topics. Topics such as alcohol, cannabis, or sex and sexuality can become difficult to investigate due to participant concerns around confidentiality and anonymity (Heath et al., 2018; McCormack, 2014). Perceived social taboos may also lead participants to be less willing to participate in research on said sensitive topics for fear of persecution. Through a clinical trial incentive system using blockchain technology, participants have the opportunity to participate in studies or surveys that they qualify for virtually and anonymously.