Paul O’Donohoe, Scientific Lead, eCOA and Mobile Health at Medidata: Reflections & Predictions

2020 Reflections

What technology do you predict will be more widely adopted and used post-pandemic that wasn’t used before?

The interesting thing about where we find ourselves in responding to the pandemic is that we haven't necessarily been using new technologies - everything we've rolled out has been solutions we've been using for many years, even decades. Remote data capture, eConsent, televisits, wearables, and decentralisation - these are all tools that have been deployed in numerous ways in clinical research before. What is new is the speed and enthusiasm with which all of these tools have been adopted to respond to the huge patient safety issues we've faced this year.

What has COVID- 19 taught us about clinical trial design and the application of decentralised trials? 

The most interesting lesson has been just how quickly this traditionally uber-conservative industry can respond and adapt when it sets its mind to it. The regulators produced helpful guidance in just a few weeks, and study teams made huge protocol changes mid-study, normally something to be avoided at all cost, in a matter of days. While obviously the hope is that we don't find ourselves in such serious circumstances in the future, I do hope we remember just how quickly significant changes and progress can be made. The pandemic has given us an intense use-case that's demonstrated the effectiveness of these virtualisation tools and with these hard lessons learned we have no excuse for not making the most of these technologies going forward.

Has the patient experience and the overall benefit to patients improved / moved higher up the agenda in 2020, and where do you see it going in 2021? 

Patient centricity has long been a buzz phrase within the industry and we've struggled to make it a meaningful philosophy for conducting trials. Technologies, and specifically those that allow us to decentralise aspects of a study such as remote data capture, eConsent, telemedicine, and wearables, have really allowed us to build patient-centric studies from the ground up. We can get input from patients during the earliest phases of the study design to ensure we're building systems that allow them to engage with the study in a way that's the least burdensome for them, while still capturing the data needed to deliver a successful study. As the industry gets increasingly comfortable with the integration of these technologies into patients' lives, and as we learn from the commercial development of apps, websites and hardware, where usability comes first, this trend will only continue.

2021 Predictions

What do you think will be the biggest challenge for the life sciences industry in 2021? 

The biggest challenge will be holding onto the lessons we've learned in the last year. As things begin to get back to some semblance of normality it will be very easy for regulators, and the industry more broadly, to drift back into doing things the "old" way, with all the conservatism and caution that brings. We've demonstrated that technology can not only improve how we're running clinical trials, but also improve the patient’s experience in the trial. We are beholden to ensuring those trends are embraced beyond COVID-19.

What are you most excited about for 2021? 

I am most excited to see what synergies emerge from bringing together all these different technologies. "Virtualisation" or "decentralisation" is often envisaged as a monolithic entity - "this is a virtual trial". In reality, decentralisation is a spectrum, with more or less aspects of the trial being conducted virtually depending on the needs of the study, the patient population and what is feasible. As we increasingly deploy studies with eCOA, wearable devices, and remote monitoring, we'll see really interesting trends emerge as we gain more insight into the patient experience. This will help us gain a better understanding of the safety and efficacy of new treatments to support better patient experiences and outcomes.