PharmaTimes talks to Dr Steve Cutler, chief executive officer at ICON plc, about the impact of the COVID pandemic and challenges of running large-scale vaccine trials

What does your day-to-day work involve?

As chief executive, I am responsible for the strategy and overall performance of the company. I spend time listening and talking to customers and driving a culture of accountability and execution, partnership, collaboration and integrity. As a service business our employees are central to our performance and I spend much of my time engaging, motivating and communicating with them. I’m also involved in communicating ICON’s approach to our shareholders and industry analysts.

What were the most challenging aspects of running the trial for the Pfizer/BioNTech COVID-19 vaccine?

From the outset, we knew the world would be watching, and waiting for the results of this trial. Therefore, it needed to happen at speed and with the highest standards of safety and quality. The Pfizer/BioNTech COVID-19 trial was one of the largest and fastest clinical trials ever conducted, involving over 44,000 volunteers across six countries and four continents. To expedite the trial, we carried out rolling submissions – submitting data to the regulators as it was generated. This of course brought challenges – the data had to be monitored and cleaned each day, meaning that for a trial of this scale, we had over 1,000 ICON personnel assigned to the trial managing the collection and quality of the data. Approximately 90% of the trial monitoring was conducted remotely – at over 150 study sites set up in the US, Latin America, Europe and South Africa. We took a global approach to solve this challenge – for example utilising a team in Japan to provide remote monitoring capabilities to cover sites in the Americas.

We could not have done this without the support of regulatory authorities and sites. This required sophisticated planning in setting up the trial, and designing an operational plan that allowed us to recruit a diverse patient population. ICON played a key role in ensuring that each clinical site was appropriate and that the investigators could deal with the volume of subjects that were required for a trial of this magnitude. There were also the operational considerations of conducting a trial in the midst of a pandemic – ensuring patient and staff safety with the use of PPE and other protective measures.

What key lessons have been learnt from undertaking this process?

Collaboration has always been important but the pandemic has shown just what can be achieved with everyone pulling in the same direction – regulators, industry, investigator sites and study subjects. We’ve seen unprecedented cooperation between regulators and different industry players, as well as fruitful collaborations between industry and academic institutions. In our own case, collaboration has helped us to shorten timelines as much as possible by removing a lot of the white space from the trial process. This was particularly noticeable with regulators. As an illustration, typically in Latin America, it can take six to 12 months to have protocols approved. We had protocols approved there in three weeks. In the US, we had a protocol submitted on a Saturday, reviewed on Sunday and approved on Monday. The US Food and Drug Administration played a key role in ensuring the trial was reviewed in a rapid fashion, while upholding strict regulatory standards. The fact Pfizer/BioNtech submitted for emergency use authorisation in 248 days is testimony to the fact that drug development can move quickly if we all align and collaborate.

Do you think the pandemic will have a permanent impact on the way clinical research is carried out?

Without a doubt, the pandemic has accelerated existing trends towards decentralised and hybrid clinical trials, while also incorporating the use of various digital technologies and remote monitoring – something ICON has long been championing. Hybrid trial design combines elements of home visits and seeing patients in traditional clinical settings. Much of this comes down to ensuring a more patient-centric trial design and implementation. By asking how we can efficiently decentralise trials so they are less burdensome for patients and investigators...and faster for industry, while maintaining or improving the quality of the information collected, we are able to bring benefits for all involved. While some indications do not lend themselves to a decentralised approach the safety benefits for both patients and investigators in a pandemic situation are clear and will help drive the acceptance of this approach in the future. The large COVID trial and others like it have acted as proof points for the benefits of remote monitoring, and helped the industry see that remote monitoring of large scale trials is not only possible, but desirable.

We are proud to have received the commendation from the FDA, who noted “the Pfizer-BioNTech COVID-19 Vaccine development has ensured the highest compliance and quality standards while progressing expeditiously to address this urgent and unmet medical need”. This endorsement should help the industry overcome any reservations around the use of technology and remote monitoring.

What can be done to further transform clinical research in the UK for the better?

There are a number of potential transformations to come out of what was a difficult 2020. First, we could be entering an era of expedited drug development with new cutting-edge drug synthesis – for example, new mRNA technology appears to be very effective, opening the door to new treatments in other clinical areas, including immuno-oncology. Decentralised and hybrid clinical trial designs also open the possibility of greater participation in clinical trials and hence improved diversity in patient populations. Finally, the acceptance and application of digital technology to clinical trial monitoring and management has taken a leap forward and the opportunity to consolidate and integrate this into our normal processes must be taken in order to move the industry forward.

What keeps you awake at night?

The industry’s focus on the pandemic is right, and I am very proud of my ICON colleagues and our partners over what has been achieved. However, I do think about all the other trials in life-threatening diseases and when the pandemic is brought under control, I hope we can all apply the same spirit and drive to speed up drug development and help to bring some of these much-needed treatments to market faster.