Pfizer and BioNTech were the first to announce positive efficacy results from a Phase 3 study of a COVID-19 vaccine and to receive Emergency Use Authorization from the U.S. FDA. The vaccine program involved 153 sites in the U.S., Europe, South Africa and Latin America and more than 44,000 trial participants.
 
ICON plc, a global CRO, provided clinical trial services to the Pfizer and BioNTech investigational COVID-19 vaccine program, including clinical monitoring services on the ground and remotely, in what is referred to as a hybrid trial design.
 
This entailed source data verification in addition to on-site monitoring, and safeguarding data quality and integrity. ICON combined full service and functional service provider clinical operating models to help increase efficiency and rapid study start-up.
 
Dr. Nuala Murphy, President of ICON Clinical Services discusses what it takes to conduct a vaccine trial of this scale, put it in a wider industry context, and the implications for the future of drug development.  –KB
 
 
Contract Pharma: In what key ways does a vaccine trial differ from a drug trial?
 
Nuala Murphy: ICON has helped develop vaccines and therapeutics for every major pandemic of the last 30 years, from Ebola to SARS and MERS, so we understand how to run these important trials in the most efficient and robust way possible. We were the only CRO to operate on the ground during the Ebola crisis. This kind of experience is invaluable when dealing with the unique operational challenges posed by a pandemic. Covid-19 is no exception.
 
ICON is currently working on more than 130 Covid-19 related clinical trials. In particular, vaccine trials lend themselves to being run remotely, as we proved in the Pfizer/BioNTech trial, not least because in a pandemic situation, it’s simply safer, both for the patients and the investigators. This trial and others like it are a proof point, and should help the industry see that remote trials are not only possible, but in many cases, desirable. This has been further supported by the FDA’s unequivocal endorsement of the quality of the data that’s come in under these settings. This endorsement should help the industry overcome any reservations and begin to apply this thinking.
 
CP: What are the main challenges and how were they overcome?
 
NM: Given the unprecedented nature of this pandemic we understood the world would be watching, and waiting, for the results, and from the outset we were aware that this trial would have to be conducted not only at speed but also with the utmost rigour. Obviously, all clinical trials are important, but to ensure speed we implemented rolling data submission to the regulators — we would submit data over time, and be able to amend over time. This required sophisticated planning in setting up the trial, and designing an operational plan.
 
We also played a key role in selecting suitable sites, and making sure each clinical setting was appropriate and that investigators were able to deal with the volume of subjects required from a trial of this size. Given the nature of vaccination programs, we had to ensure we recruited a diverse and representative patient population. Again, this was about selecting the right sites, and managing patient recruitment. There were also the operational considerations of conducting a trial in the middle of a pandemic – we had to ensure patient and staff safety, which we did through the use of PPE and other measures, for example.
 
CP: Vaccine/drug development has been permanently altered by the pandemic, what are the implications for the future of drug development?
 
NM: ICON will certainly be taking the lessons learned during the pandemic and applying them to drug development more widely. If there is a positive development to salvage from what has been an extremely difficult year, it is that we could be entering an era of expedited drug development with new cutting-edge technologies. The expedited development of Covid-19 vaccines shows what is achievable in terms of bringing much-needed treatments to market, and the pandemic has accelerated existing trends. For example, new MRNA technology appears to be very effective, opening the door to new treatments in other clinical areas, including immuno-oncology.
 
CP: Do you anticipate greater use of decentralized and hybrid trials post pandemic?
 
NM: This an example of how the pandemic has accelerated existing trends. The move towards decentralized and hybrid clinical trials is something ICON has long been championing, as we believe it can not only accelerate drug development, but also make research and development less costly – R&D is the single biggest cost in bringing new drugs to market and this has only increased over the last ten years. We need to bring that cost down. Much of this comes down to patient-centric trial design. How do you decentralize trials so they are faster and easier for patients, investigators and the industry? There are huge benefits to answering these questions.