By Deborah Borfitz 

March 10, 2021 | Many of the process-related changes Janssen made in response to COVID-19—including virtual investigator meetings, analytic risk-based monitoring (ARBM), and direct-to-participant clinical trial approaches—will endure beyond the pandemic, according to Darren Weston, vice president and head of data analytics and reporting, during a keynote he delivered at last week’s Summit for Clinical Ops Executives (SCOPE). “We by no means have this down to a fine art, but… we are in a much better place having gone through these chapters.” 

The first step, when hit with the public health crisis, was to come up with a business continuity plan for the study portfolio, Weston says. While many companies were announcing cross-portfolio decisions, Janssen instead focused on how to continue moving programs forward to meet the needs of patients while protecting the safety and welfare of site staff and employees.

Teams “rose to the challenge” of nimbly adapting to changing conditions in countries where trials were underway, he says. Seemingly overnight, monitoring and site activities were being performed 30% on site and 70% remotely—a total flip from business as usual. 

More sites in the U.S. also began allowing remote source data verification, and the shift is now being seen in other countries as well, says Weston. However, opinions clearly diverge on the matter across regulatory agencies.   

Janssen opted to virtualize nearly all its investigator meetings, and ARBM became more of a pivotal than nice-to-have tool in its armory, he continues. Multiple composite risk scores were deployed for more holistic risk evaluations of sites and the instrument resides on a central monitoring dashboard with several other tools, including a protocol deviation classifier.

“We also created standard risk analysis packages that enable insights by therapeutic area, project, study, and country,” says Weston. “Our teams were forced to assess and adjust plans, rationalizing source data verifications and source data review, in addition to ensuring we could reduce the site burden by focusing [them] on data queries that matter.” 

Monitors had to be leveraged as efficiently as possible, he says, noting the shift to a more regionally focused model versus flying people from coast to coast. Communications also became centralized to a dedicated team tasked with staying on top of rapidly evolving, COVID-related process changes, and contracts more often employed templates and eSignatures.

Clinical Relaunch 

A clinical relaunch program was devised that integrates various clinical operations and therapeutic area leaders to “collectively absorb” information on pandemic-related changes and their expected impact to align expectations and arrive at a go-forward strategy, Weston explains. The overall effects on the portfolio (including the financial impact) get monitored by therapeutic area, country, and study, as reflected in a clinical relaunch dashboard. 

Janssen’s data science team ensured the dashboard could additionally track the spread of COVID-19 and the rollout of COVID-19 vaccines. Teams were further armed with consolidated insights regarding site accessibility and therefore patient access, he says. All that information was further combined with input from site staff.

The clinical relaunch team, in partnership with the statistics group, performed a risk assessment of the portfolio to determine the COVID-19 impact, including “data missingness,” Weston says. This was formalized into a quality tolerance limits assessment that is part of Janssen’s ongoing risk review process. 

The company’s decentralized clinical trial capabilities fall under Janssen’s Trials2You program, he continues. “We’re balancing study fit with the benefit derived for patients and sites and considering vendor capabilities and feasibility assessments. We’ll also continue to ask patients directly what they need to be successful in our trials and this input will guide our decision-making.” 

Patient preferences have clearly changed during the pandemic, says Weston. For example, they are more interested in using telehealth in clinical trials because of their experience with it in other healthcare settings. 

COVID-19 has also forced Janssen to speed deployment of home health nursing to 22 trials in 55 countries—and expanding. “It is very much a fit-for-purpose capability,” says Weston. “Sites can opt in and out. It’s pretty flexible.” 

Sites can largely provide remote trial visits using their existing technology, he adds. Janssen enabled eConsent and, by the middle of 2020, was also directly shipping investigational products to trial participants in over 30 countries across most therapeutic areas.

Can-Do Attitude

Among the many lessons learned was to accept risk but address it with rigor, says Weston. Janssen has also seen the value in being more pragmatic and acting with urgency.

“We have traditionally adopted a staged approach to innovation where we engage in an ideation stage, assessing the alignment to our portfolio and then proceeding with various demonstrations, leading to an implementation phase,” he says. For several innovations rapidly deployed to manage COVID-19, however, “we saw a blurring of the lines through these stages of innovation… [and] that was refreshing to see.”

Janssen effectively “demonstrated a small company can-do attitude,” says Weston. “Organizations can do amazing things in short bursts, but it isn’t necessarily sustainable.” Managing organizational fatigue is critical.

The knowledge exchange that has happened across therapeutic areas “created awareness that we have much more in common than not as it relates to clinical trial delivery,” Weston says. Thinking differently about what is possible is what helped fuel innovation.  

“We have also learned that ARBM is a really good thing,” he adds, especially when it is applied in a fit-for-purpose fashion for a given study. 

Overall, Janssen has become “more change-agile and change-resilient,” Weston says. “We have managed to significantly minimize the impact [of the pandemic] on our trials.”

In the first half of 2020, patient enrollment was up 20% relative to the same period a year earlier, he notes. “We only paused a small fraction of our more than 400 ongoing studies.”