The speed with which Pfizer was able to develop its COVID-19 vaccine with BioNTech can be replicated by other sponsors if they do things in parallel, determine how much risk they are willing to shoulder upfront and think of clinical trials as one large protocol rather than taking a traditional phased approach.

Ralph Russo, senior director and global head for clinical database management at Pfizer, said performing tasks in parallel, rather than sequentially, enabled the company to design a data collection protocol quickly. He said the vaccine’s development team took a “slot team” approach to make sure everything that was needed for their clinical trial was at the ready.

“The expectation was that once the patients were enrolled, there would be a swift need for either safety review or other data reporting events that we needed,” Russo says. “We needed the end-to-end apparatus for data flow completely completed by the time the study went live in March. Our goal was to get the cycle time down to a six- to eight-week timeframe between the final approved protocol and database activation.”

According to Russo, Pfizer’s success could be replicated by encouraging rapid, disciplined decisionmaking, being flexible and minimizing white space — the amount of time lost between phases of a clinical trial. “We are moving into an era where studies are more complex … Your organization has to be able to work quickly over the course of the life of the study, not just the startup, to get that agility and get the drugs to market more quickly,” he told attendees of a webinar sponsored by Oracle Health Sciences (OHS) and CenterWatch.

Elvin Thalund, director of industry strategy for OHS, said quality should not suffer as a result of quicker action. “You need to be agile and be able to do these changes fast, especially when you put more phases into one protocol. We need to start thinking that [protocol] amendments are not necessarily bad.”

Russo concurred. “The key is really to think about how can we make that protocol outline and make it more robust? Scheduled activities is probably the key component, but there are other things as well, such as dosing, identifying novel assessments and trying to be as detailed as possible so we can think about what the data entry screen is going to look [like], how we’re going to submit, etc. We can start that early, get those standard requests. That can be built and be available for the study builder to incorporate right before testing.”

Jonathan Rowe, associate principal for R&D excellence at ZS Management Consulting, said sponsors should consider the risks they are willing to take and match them against the resources they are willing to invest. “This is a real nice way to understand your organizational culture for risk,” he says. “This is going to become the norm as other companies show success.”

Thalund said sponsors “traditionally just do one phase at a time, or you can go in and do full clinical development, which is close to what Pfizer ended up doing. You think about it all as one big protocol. Because in the end, you actually know all the information when you set up your clinical development plan. It’s the same risk that will occur for the patient across all phases, so there’s no reason why you couldn’t plan it as a whole.” He adds that if sponsors “start involving the regulatory bodies that have to review the data early in the process, they get comfortable. They get their concerns answered earlier in the process.”

“You should start thinking more in primary endpoints than in actual phases. Because in reality, what you’re trying to manage is these primary endpoints and the expected outcomes across them. Then you can then take that even further down to a protocol that could cover the multiple phases,” he said.

Thalund added that most trials put out a statement during study startup outlining such things as first patient, first visit and site initiation visit (SIV). Sponsors then start to plan backward from there. “In general, people take their due time, and then when the squeaky wheel of SIV gets closer, then people start working. It doesn’t mean people are not working, they’re just not working on what is critical in many cases.”