Virtual Clinical Trials: A Promising Solution to Mitigate Trial Interruptions

The COVID-19 pandemic has tested the limits of healthcare infrastructure and economy of most nations across the globe. There has been a disruption in the balance across industries, with each sector struggling to combat the challenges thrown at them. Various countries around the world are at various stages of identifying a new medication/therapy and vaccines to counter the outbreak. Major concerns have risen for all in line of work in the field of clinical trials. Never has the vaccine development, drug development and its widespread clinical use been so swift.^1-3India is amongst one of the major contributors in clinical trials since 2014. Despite delayed entry, India presented a tremendous growth potential in clinical research due to its high disease prevalence and treatment-naïve patient pools. Further, the modifications in regulations, population growth, diversity and the investing nature have contributed to the growth of the clinical trial industry in India. Additionally, vast and genetically diverse population, well-equipped hospitals, low cost of setting up and execution of clinical trials have sparked an increase in interest in conducting more clinical trials in India.^4,5

A novelty that the pandemic brought in is the unification of the scientific and medical community, leading to the identification of opportunities to model treatment strategies. Consequently, there has been a sudden surge in the number of clinical trials studying outcomes with novel therapeutics.⁶

The lockdown poses a challenge for clinical trials not only in India but globally. Though directives and regulations are in place for conducting trials during this pandemic, they are not uniform across countries. Lack of clarity, economic slowdown, and human resource restrictions have created confusion amongst researchers, investigators, Contract Research Organizations (CROs), and other stakeholders to conduct uninterrupted clinical trials.⁷

Virtual platform could be a promising tool to address the unprecedented obstacles. By expanding the geographic reach, virtual platforms grant access to diverse populations and difficult-to-recruit candidates, allowing faster assessments and recruitment of select patient groups for targeted clinical trials. Virtual platforms have emerged as a popular tool and gaining increased. The COVID-19 pandemic is a potential opportunity to explore virtual platforms (Figure 1) further and explore its applications to simplify clinical trials with fewer errors and shorter timelines.

The amalgamation of digital tools such as cell phones, mobile apps, remote monitoring devices, and social media platforms with research designs is promising. Effective application of digital health technologies for data collection of the clinical trial accelerates patient recruitment, strengthen patient engagement, improves patient safety, reducing complexity and trial timelines. It also aids in obtaining online-based informed consents, real-time calculation of clinical endpoints, and regular tracking of any adverse events.^8,9 Increased use of internet-based sharing and conferencing platforms during the lockdown could open a gateway for remote monitoring and educating participant through a digital concierge experience that supports participation from their place.

Remote monitoring is a solution which a lot of organizations are advocating currently. However, limited resources and funding remain critical limiting factors. One of the major concerns remains the privacy and confidentiality that arises with setting up of virtual testing and the onus rests on the trial personnel to maintain confidentiality during the sharing and transfer of data.

Risk Assessment with the help of information technology and web services could help better understand the issues and concerns of participants which in turn can help the company/institution in finding solution to trouble shoot the issues faced.⁸

Delivery of investigational product (IP) or drug in compliance with protocol to participants at their respective homes is one way adopted to continue the study and overcome the travel limitation and reduce the visit of participants to the site. Such efforts introduced by institution or company to convince the participants to continue to take part in trial adds financial weight that may be hard to cover up.¹⁰Lack of proper communication system between the review committee and sponsor or investigator often results in delay in the decision making process, making the overall work more tedious. Lack in efficiency of online portals such as SUGAM, for registration of new clinical trials in India and absence in the provision to make online submission increases the inconvenience faced by the company/institution.¹¹Participants currently in clinical trials need to be examined for COVID-19 cases which require additional testing apart from the standard tests mentioned beforehand in the protocol. Moreover, investigators and the site team have to be trained to face the challenges in the trial in the current scenario. Clinical extension in this period of clinical trial results in additional expense and charges which in some cases can lead to financial dilemma. Flexibility and amendment in the study design and protocol with alternative process has helped in overcoming some challenges faced in the clinical trials to an extent, with room for more improvement and modifications. A potential challenge during the conduct of clinical trials during lockdown has been monitoring of the trials. With poor connectivity, this becomes even more challenging. Virtual testing comes in as a saviour. Concerns such as trial participants visiting a potential health risk site and increasing the risk of contact gets mitigated.

Virtual clinical trials offer a promising avenue; however, this platform will have to be tested extensively before widespread acceptance and implementation. Current challenges that preclude widespread use include availability of internet, digital technology for video monitoring and documentation, and most importantly data security.

Not just in the research world but across spectrums, virtual platforms have received an unparalleled acceptance and in this COVID-19 pandemic crisis, we believe virtual platforms will help to conduct research safely and effectively.

Conflict of interest

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Funding

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