Across the world, one thing that has been a hot topic since the pandemic started is the arrival of a COVID-19 vaccine. COVID-19 led several pharma companies to pursue vaccine production with aggressive deadlines and a sense of urgency in developing and bringing to market. People around the world have closely followed the vaccine candidates advancing each phase of clinical trials.
Impacted by the COVID-19 pandemic, many in-person activities have turned virtual for obvious reasons. A report published by Informa on Decentralised & Hybrid trials indicates that COVID-19 and the country-wise lockdowns have in fact resulted in increased use of decentralised / virtual trials.
Recent numbers point to an increase in funding for technology startups that provide virtual trial platforms powered by Artificial Intelligence (AI) and Machine Learning (ML). The advent of digital technologies paved the way for clinical research organisations conducting trials virtually. Virtual clinical trials make use of digital health technologies for information collection at every stage, thus helping improve patient recruitment and retention, which is a major challenge for traditional clinical trials, and monitor patient safety along with real-time data tracking and measurement. Over the past few years, there were attempts to decentralise clinical trials laying a path for continued experimentation and potential adoption in the long-run.
In 2011, Pfizer pioneered the virtual clinical trial model when it conducted a randomised trial using mobile phones and web-based technologies, in a bid to validate virtual, patient-centred approach to clinical research. Patient enrolment was a major issue for this study, but Pfizer published the results indicating this approach was safe and equally effective as a traditional trial. Pharma companies like Sanofi also took up this approach a few years later by partnering with technology companies, albeit with limited success. Regulatory restrictions and various other reasons became a roadblock for companies to adopt virtual clinical trials on a wider scale.
The US Food and Drug Association (FDA) had early this year issued guidance on evaluating alternative assessment methods for clinical trials during public health emergencies. A recent update to the guidance suggests investigators consider alternative assessment methods for clinical trials, remote or virtual trials, while emphasising the need for patient safety. Adoption of virtual trials has been accelerated by the pandemic and it is worth noting that the shift to this has not been purely innovation-driven but rather a risk mitigation approach in the current global healthcare landscape.
With a focus on patient-centricity and increased use of digital health technologies for accurate data collection and real-time patient monitoring, benefits associated with virtual clinical trials outweigh the traditional model. But there’s little evidence to suggest the industry is in for a complete shift from conventional clinical trial approach. Clinical research and pharma organisations will do well to embrace hybrid models as the industry commits to bring about a meaningful change that benefits business and the global population at large.
This issue features an article by Ayaaz Khan, Global Head of Generics at Navitas Life Sciences, that revolves around how AI can play a key role in transformation of clinical trials into virtual mode for improved efficiency.
Prasanthi Sadhu, Editor, Pharma Focus Asia
