Lessons from the Pandemic: Remote first trials
Traditional drug development is excruciatingly slow. From 2010–2020 the average time from the first submission to regulator sign-off was over 9 years, and that’s after potentially decades of R&D to deliver the drug candidate. Yet in response to COVID-19 the pharmaceutical industry, their regulators and governments around the world overcame decades of status quo process to deliver highly effective vaccines within a single year.
In a society crying out for new infrastructure solutions responding to energy security, climate change and shifting demographics we must learn from this harrowing experience to accelerate the design and delivery of critical infrastructure projects.
The Status Quo
The past 50 years of pharmaceutical development have been defined by the tug and pull of innovation vs safety. The greater the opportunity, the greater the risk, and risk in healthcare is not merely about profit and loss.
Clinical trials are the primary risk management tool in drug development, carefully testing drug candidates with a broad range of participants to understand effectiveness and side effects. Traditionally oversight and governance had to be local to trial participants, with trial locations minimised to manage costs whilst achieving the level of data collection regulators required.
As a consequence of this, it was often difficult to collect such data of sufficient sample size and participant diversity (e.g different ethnicities or pre-existing conditions) to satisfy regulatory requirements causing delays and increased costs as trials were re-run. These challenges have often delayed the approval of life-saving drugs such as HIV vaccines for decades.
Remote first trials
With the onslaught of COVID-19 governments didn’t have decades to wait, and a global pandemic required a global response.
Rather than working in isolation with limited clinical trial sites the pharmaceutical industry and its regulators developed a model of collaboration with local hospitals in regions across the globe whilst ensuring consistency and safety through remote services for the first time. A centralised management and governance team working primarily from Japan, coordinating 43,000 trial participants across over 100 sites spread from Birmingham to Bangalore.
A common technology platform across all trials enabled consistent data collection and risk management wherever participants lived with best practices shared across the network of trial sites as quickly as the most viral internet memes.
Whilst in the past this would have been considered an unnecessary luxury the sector has learnt that once the centralised services to coordinate and ensure the safety of such trials are set up, it is only marginally more expensive to operate trials in 100 locations as it were for 10, achieving scale never before seen across the industry. The model has demonstrated the industry can deliver radical innovation and improve safety simultaneously it's not an either-or choice.
Remote first delivery
“The world is Flat” — Milton Friedman
Many sectors including infrastructure could learn from the pharmaceutical industry's experience to radically improve the speed and quality of their service delivery.
Across the infrastructure sector, the closing of offices during COVID-19 has led to a radical reshaping of the workplace. Within a leading UK engineering consultancy pre-COVID, 55% of projects were staffed only by professionals working within 100 miles of each other, and Post-COVID, 70% of projects are staffed by professionals working within 3,000 miles of each other.
Excluding projects relating to National Security, professional services in the Infrastructure sector are re-orienting to a model where clients can access talent globally rather than just those available in the local office. Whilst many international professional services firms have claimed for decades that their global reach is a differentiator, in the 2020s for the first time this is actually true.
Regulatory processes and the gauntlet of planning permission have an even larger opportunity to re-imagine how they operate. Pre-COVID, local engagement and planning consultations were almost always face-to-face. This often led to limited engagement with the public as only those able (physically or due to time constraints) to arrive at a town hall meeting room on a certain date/time would have the opportunity to state their views.
If you limit the opportunity for engagement with the planning processes it is not unexpected that only those with the most forthright views expend the effort to air them. Taking a remote-first approach to planning permission will enable a far greater diversity of voices to be heard and viewpoints to be considered. It will introduce a new range of challenges however such as requiring new technologies and skillsets to present schemes digitally and facilitate public engagement with sufficient confidence to capture the diversity of opinion.
In the UK such proactive and professional ways of working will only become more important if and when ‘Street Votes’ as proposed by the current government is introduced. In practical terms, by encouraging or even requiring input from all residents of the area in question, current ways of working will not be suitable for effective communication, facilitation and consideration of such a diversity of views. Only a remote-first approach would have the scalability and flexibility required to respond to the increasing volume of consultations as the UK government responds to the challenges of climate change, energy security and shifting demographics.
About Continuum Industries
Continuum Industries is a provider of an AI-powered infrastructure development platform, Optioneer, that enables power, utility and renewables companies to instantly visualise, analyse and comprehensively assess routing options for power lines, cables and pipelines.
By incorporating all environmental constraints into the development process from the very beginning and considering them together with social, engineering and cost criteria, Optioneer bridges the gap between existing routing procedures and the pace at which project development needs to happen to meet Net Zero targets.