OR WAIT null SECS
As we enter a post-pandemic era, many of us still contemplate what we’ve been through, and how to move forward. The pandemic shifted the way we operate clinical trials, but now that the world is entering a new normal, what will clinical trials look like? In this interview, Terence Rooney, VP of Clinical Development at Janssen, will take us through a journey of how Janssen changed during the pandemic, and what the future will hold.
Moe Alsumidaie: How did the pandemic impact clinical trials for Janssen immunology?
Terence Rooney: As the pandemic broke in March, we assembled an Immunology COVID-19 Operations Task Force, with representation from early and late phase clinical development, medical safety, medical affairs, clinical operations, regulatory, Quality, quantitative sciences (biostats), project management, and other functions. This group drove and coordinated our approach to our R&D clinical trial activities in the context of the pandemic crisis.
The three biggest challenges that the pandemic created for our clinical trials were in the areas of: patient safety and wellbeing, study integrity, and study recruitment. To ensure patient safety and wellbeing we created processes to stay abreast of everchanging local safety and quarantine guidance and to adjust to protect patient wellbeing first and foremost. As for study integrity, we recognized that the systems and processes for data capture, correction, maintenance, transmission, and retention could be impacted by the pandemic and required that we be nimble with regard to adjustments or postponement. Finally, the pandemic hindered recruitment for our clinical trials impacting both patient and staff participation. In the interim, we developed supportive content and activated online communication mechanisms to stay in close communication with our patients, study sites, administrators, and sponsors to manage questions and concerns remotely as well as support data collection.
MA: When the pandemic hit, what did Janssen do to stay its course and continue to advance its studies?
TR: As a priority, the COVID-19 Operations Task Force established foundational guiding principles and communicated them to study teams and investigative site partners—these principles included following up-to-date guidance about the pandemic from local/regional authorities, following approved study protocols, keeping communications open between Janssen and investigators and their staffs, and specifying that final decisions for individual patient care were at the discretion of investigators, based on their medical judgment. These principles seem apparent, but it was helpful to put them in writing and share them and emphasize that they were developed with patient safety and wellbeing in mind.
MA: Were there any special adjustments to protocols? Study sites? Patient tracking? Patient visits?
TR: Janssen developed and deployed means to track the pandemic’s impact on our studies. We looked at factors such as the instances of COVID infection reported in study subjects and the operational implications of pandemic disruptions on study conduct – including enrollment and post-enrollment study activities such as dosing and patient visits/data acquisition.
MA: How was patient recruitment impacted?
TR: With pandemic tracking information, we tailored our approach to our trials—including pausing vs. permitting screening and enrollment based on our evolving assessment of the pandemic’s epidemiology, its impact on our study patients, conduct, and data, as well as what was happening across the industry. Our trials are global, allowing us to adjust trial locations and practices, depending on what was happening in one country or region.
MA: Did Janssen implement any new digital technologies that it may not have used before for monitoring, sampling, communication? What were they? How did it go?
TR: Our COVID-19 Operations Task Force steered adaptations in the conduct of our studies to prioritize patient wellbeing and study integrity while maintaining compliance with regulatory/GCP/other applicable standards. Transformations in clinical trial conduct included remote visits, direct-to-patient provision of study drugs, and exclusion of subjects with recent COVID infection from study enrollment. In terms of communication among the team, we relied on intranet sites, regular meetings with Zoom, and other methods to keep our staff connected to internal and external guidance and additional news flow relevant to trial conduct.
Across Janssen Research and Development we developed and deployed an interactive platform that integrated public data sources on COVID infection (and then vaccination) rates by geography, overlaying our trial sites and including forecasting algorithms. Detailed feedback from our local sources provided texture as to local logistical conditions providing key information regarding the virus, patient, and staff challenges. This allowed us to adapt our global resources appropriately as COVID waxed and waned by region.
MA: Is Janssen doing anything to move to a model of decentralized clinical trials? Or are there any new remote processes or technologies implemented during the pandemic that you found valuable and may continue using post-pandemic?
TR: As a general direction and where it makes sense, yes. We have had to adapt many ways of working to deal with the demands of the pandemic and are certainly looking to retain the best and most valuable of these innovations in our practices in the future. Offering greater flexibility in how we bring our clinical trials to patients is undoubtedly one of these themes.
Two major innovations in our clinical trial practices will stay post-pandemic: data science approaches to trial recruitment and technologies that enable remote trial conduct. They match trials to the right sites and patients and make those trials attractive and flexible to participate in. We will retain and develop these innovations to help speed our potential medicines to patients, to stay competitive, and to be prepared for future crises like the present one.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.