Paul O’Donohoe
Senior Director, eCOA Product and Science, Medidata
Fiona Maini
Principal, Global Compliance and Strategy, Medidata
Innovative technology and lessons learned from the COVID-19 pandemic can be used to steer the future of clinical research and bolster patient participation.
Much has been written about post-pandemic recovery and returning to normal but many of the disruptions experienced across the clinical research sector, notably the delay or cancellation of in-person trials, have offered up real opportunities for innovation and change.
Paul O’Donohoe, a senior director at Medidata, a clinical software platform provider and a Dassault Systèmes company, is responsible for developing the company’s scientific and technical expertise for electronic clinical outcome assessments (eCOA) and mobile health in clinical trials. He says: “Many things like remote data capture, wearable devices and decentralised clinical trials (DCTs) have been around for a long time but their adoption was accelerated as a workable solution to lockdowns and restrictions due to the pandemic.” This also enabled pharmaceutical companies to bring vaccines and treatments onto the market in months rather than years.
Medidata’s DCT Program – the first in the world to unify direct patient data capture technology with study oversight and monitoring, representing a truly end-to-end solution on one single platform – offered researchers the chance to run a completely remote trial or a hybrid programme.
Improved patient environment
The move away from onsite attendance coupled with faster approval, adoption and availability of wearables and remote access technology improved patient involvement and engagement. O’Donohoe says: “Patient centricity is talked about so much in the industry that it has almost become meaningless, but it’s really a reflection of the challenges in patient recruitment and retention. DCTs have not only increased the number of participants in terms of reach and diversity – making it possible for individuals to be involved regardless of location but have also reduced patient burden as participation is easier to fit around different lifestyles.”
The industry showed how quickly it was able to respond to the pandemic and we need to make sure that those lessons are not lost.
Lessons learned
Fiona Maini, global compliance and strategy principal at Medidata focuses on the regulatory aspects of new tech and innovation in clinical trials. She believes that lessons learned from the last two years underline how industry can advance health care through technological optimisation and prioritising digital trial solutions from a regulatory perspective. “The industry showed how quickly it was able to respond to the pandemic and we need to make sure that those lessons are not lost.”
Regulatory bodies worldwide were quick to recognise DCTs and remote technology solutions such as remote monitoring and electronic informed consent (eConsent).
Maini chairs a DCT working party with the Association of Clinical Research Organisations (ACRO), established in 2019 to identify barriers to the adoption of DCTs and facilitate their implementation. She says: “A DCT approach allowed some clinical trials to continue during the pandemic which meant that patient care and evaluation could continue. By using remote strategies, we have formulated a vision and developed a toolkit for how DCTs can be planned and executed now and in the future”.
Collaboration is key
Another aspect which Maini believes should be built upon is the collaboration between industry, academia and authorities. “The pandemic emphasised that collaboration is vital in addressing and establishing priorities and frameworks to face challenges that affected the whole sector.”
Regulatory pragmatism won, which was particularly vital in the UK where the industry faced Brexit legislation, updated EU regulations (like the new medical device regulation) and the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Delivery Plan. The MHRA’s Delivery Plan 2021-2023 promises a progressive agenda for the life sciences sector and its aim of putting patients first is in line with Medidata’s commitment.
Both Maini and O’Donohoe are optimistic that if the industry can learn from current challenges and maintain the considerable advantages of technology that fell into place during the pandemic, the sector will be well-placed to modernise and future-proof itself.