With the ongoing COVID-19 pandemic, virtual has become the new normal. From online lockdown quizzes to virtual events, communication through a screen has become standard to most of the world. Most importantly, virtual has become urgent for the future of clinical trials. In many cases, virtual is the only way to complete studies. In this blog, we will explore what virtual clinical trials are and some of the benefits and challenges of conducting virtual trials.
What is a virtual clinical trial?
A virtual clinical trial (or decentralised trial) is an emerging methodological approach for conducting clinical research using technologies and online social engagement platforms. The exact definition differs among individuals. While some regard it as almost any patient-facing technology, others feel the term should only be used for studies where every aspect of it is technology-based. This includes patient recruitment, consent and data collection.
Why do we need virtual clinical trials?
Patient recruitment and retention remain key challenges for pharma companies. Estimates suggest that 50% of clinical trials fail to recruit enough patients during the initial recruitment period and 40% of patients on average dropout. Patient-facing technologies can help widen the pool of trial participants. Thereby, increasing retention and improving data quality and overall patient experience. These technologies provide an opportunity to move towards a patient-centric trial experience. Additionally, they allow regular patient interactions and provide reminders that are integral to keeping patients motivated during trials. Most importantly, virtual trials can streamline trial workflow and shorten timelines, which in turn could accelerate regulatory approval. In addition, these trials can reduce the variation in data collection and provide near real-time data that can enhance the safety of a trial.
What is the future of virtual clinical trials?
Clinical trial diversity is an ongoing issue, as seen with COVID-19 clinical trials. In this case, technology can in some ways be an enabler of increasing trial diversity. Nonetheless, there are several obstacles that remain in incorporating virtual components into trials. These include:
- Lack of data integration – These technologies and devices produce a lot of data that cannot be aggregated in ways that allow for effective analysis.
- Patient safety – There are concerns that without direct contact with sites or researchers there may not be enough recognition of serious adverse events.
- Unclear regulatory acceptance – Regulators are not ready to accept digital endpoints.
- Data protection – There are concerns about the safety of personal patient data over the internet.
There are several barriers to diversity in clinical trials. These include lack of awareness, mistrust, financial and logistical constraints, implicit bias, language barriers and low health literacy. During our recent D4 Global virtual event, Elizabeth George, Director, Clinical Trial Diversity, GSK, discussed the promises and opportunity of virtual clinical trials. Elizabeth noted that improving patient journey could increase patient participation and retention. She also stressed that the focus should be on the patient and not just about using technology for the sake of it.
Conclusion
Virtual elements within clinical trials, now and in the future, are likely to be prominent features of clinical trials. These trials have the ability to remove barriers to bring about greater efficiencies. They harness advanced technology in order to simplify patient experience. By improving patient journey, participation and retention are likely to increase and overall satisfaction with clinical research improve. This, in turn, will build trust for future trials. Nevertheless, virtual trials alone will not be enough to increase diversity in clinical trials. They must be paired with other strategies that will target the relevant demographics, including community engagement that is essential to build trust and awareness.
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