Biopharmaceutical Clinical Studies Operations Changes During Pandemic

Clinical operations personnel are known to exercise rigidity in their operating models and are resistant to change. However, the COVID pandemic has forced many to expand their perspectives to operate in this new environment. In this interview, Dr. Peter St. Wecker, Director of Clinical Process Improvement & Innovation at Zogenix, will offer a unique perspective on clinical studies operations challenges and changes that sponsors and sites underwent during the pandemic.

Moe Alsumidaie: I hear that there is a decline in new trials started in 2020. What factors are contributing to that?

Peter St. Wecker: The decline in new trial starts last year came from a multitude of places. COVID has had a significant impact on companies’ decisions about whether it was the right time to start new trials. Sites, for example, experienced limited or decreased staff availability. For us, the challenge of getting in touch with sites and were able or ready, with the demands of COVID, to start a new trial. Additionally, with the changing landscape in regulations, sponsors have been figuring out how to navigate new regulations, which may also be contributing to their readiness to start new trials.

Naturally, we had to deal with the initial shock of being in a pandemic, and adjust to the way we work nowadays, being fully remote. The initial challenge was how to keep studies operational while being completely remote; for example, when we’re not able to visit sites and patients cannot go in for their study visits. The clinical trials industry is understandably resistant to change and embracing new technologies and innovative methods for operating studies until they are well proven and scalable. For instance, even though niche vendors exist and offer remarkable technologies to advance decentralization and remote access to sites, it was not easy to scale across study teams.

When companies boast about their success stories of implementing decentralized clinical trials, I think that’s been the exception to the rule. The reality is that we’ve used our existing systems to deal with patient access, site access, and team access; we had to uproot all of that and change our processes from the ground up. Not to mention the challenges of convincing and training clinical operations personnel to execute studies using those new processes in a brief timeframe. After we restructured our clinical trial operating models to support decentralization, such as conducting telemedicine visits, delivering investigational medications to patients’ homes, and collecting data through electronic means, such as electronic patient-reported outcomes (ePROs), that’s when we started to see progress in trials continuing successfully.

MA: What would you say was the most exciting innovation that you’ve seen emerge from this pandemic?

PSW: The most exciting innovation I’ve seen is how rapidly regulators addressed needed changes in clinical operations during the pandemic and sponsors’ quick response to change how they operate trials during the pandemic. As an industry, these recommendations were valuable, as we could leverage the regulators’ recommendations to allow for studies to go on. That partnership with sponsors and how they’ve made those adjustments quickly, given how slow we’ve seen some changes occur in the past, has been great. I also found that the ability of clinical operations personnel to rise to the challenge and exercise their impressive creativity and brainpower to find novel solutions and operating practices was mind-blowing.

MA: What was it like to transition the organization into a remote working model?

At Zogenix, we were well prepared, as we invested in a robust internal IT infrastructure, which supported an easier transition to remote access for all of our employees. It is essential to trust employees to achieve the study’s deliverables and milestones by the defined timelines, despite the challenges that come with working from home. From what I’ve seen, we’ve been successful in our transition, and we have embraced remote work as a part of our lives and culture.

MA: Have there been any changes in SOPs to support these new changes?

PSW: Before the pandemic, my experience was that many sponsors would never allow CROs to conduct remote monitoring of study sites and would have SOPs specifically prohibiting such practices. Now the SOPs have changed to support remote monitoring, specifying the need for remote access to EMR systems and other source data. Other areas where SOPs have changed involve shipping investigational medication directly to the patients’ homes and allowing for study visits to be conducted remotely.

MA: How have study sites responded to these novel remote procedures?

PSW: Like everyone else, I think sites have been challenged with staff working remotely and figuring out how to address resource challenges. Sites were overwhelmed and put under much pressure by all sponsor companies, suddenly coming up with new processes and changing their procedures for running studies during the pandemic. Not only that, but each sponsor company was also operating their trials differently, so sites have expressed concerns that they were receiving calls from multiple people and companies wanting to do things differently.

Then there were institutional changes that site staff had to deal with, such as resource allocation and creating processes to enable remote access to their EMR and other source data systems while maintaining high patient protection and privacy levels. Despite these challenges, sites have been innovative and have been working fast to give sponsors access to their electronic systems to support remote monitoring while maintaining the protections and the well-being of patients, monitors, and site staff. This was a remarkable feat that sites have achieved to adapt to this new environment.

MA: What has this pandemic done to the clinical trials industry?

PSW: What comes out of all this is a real positive change in the industry, the collaboration between parties, and sharing pre-competitive information to overcome hurdles. There have been many great discussions, webinars, and virtual conferences where sponsors, sites, CROs, and others have shared their ideas for how to best overcome these challenges. And we’ve all, in many ways, come together to help each other. We can still be competitive but can accomplish a lot more as an industry by working together for the good of the patients. We can always be good corporate citizens for our shareholders, our patients, and healthcare while still sharing best practices that we can all use to run studies and get new medicines developed in these challenging times.

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.