Big Pharma Was Prepared for COVID-19

It is clear that the COVID-19 pandemic has changed the clinical trial paradigm. However, some companies have implemented a culture of innovation and have invested heavily in piloting novel technologies before the pandemic, which mitigated pandemic-related risks. In this interview, Disa Lee Choun, Head of Innovation at UCB, will discuss how the company has fostered a culture of innovation, and how the investment in piloting has benefitted clinical operational implementation during the pandemic.

Moe Alsumidaie: What challenges and impacts has COVID-19 had on clinical trials at UCB?

Disa Lee Choun

Disa Lee Choun: There were many challenges. One immediate challenge was the effect on clinical trial recruitment. This led to a temporary halt in our ongoing clinical studies and delayed the start of new studies. These actions were taken into consideration for patients and public health safety. Other challenges were that some sites were closed to patients, especially for ongoing studies. Also, sites were closed to site monitoring visits due to the local restrictions and lockdowns. For the participants, the concern was how they can continue to receive the treatments, how we can continue to collect the assessments, and how the investigating physicians continue to monitor their safety. Other considerations were around, for example, understanding and applying the new guidance from the regulatory agencies issued during this pandemic from FDA, EMA, and others. We were also investigating applying solutions we were piloting through our digital transformation initiatives to be deployed rapidly to minimize the impact on these ongoing clinical trials and to continue to ensure the patients’ safety and wellbeing.

MA: How did you overcome these challenges?

DLC: Within UCB, a team worked on contingency plans. It was a great collaboration from various experts to ensure that solutions and options were provided to ongoing and new studies. For example, one solution we implemented included direct-to-patient investigational drug shipments, which allowed patients to receive treatments at home. Usually, these activities would be done at the site. Also, a specific team was formed, led by me, focusing on supporting fundamental studies and identifying critical issues and prioritizing those and providing innovative solutions from, for example, telemedicine, remote assessments, wearables, devices, remote SDV/SDR (Source Data Verification/Source Data Review), with the intent to roll out to any studies that might need or require those solutions.

It was a great effort and coordination with various stakeholders and experts in the field. The positive side is that many of these solutions were already underway, and some were deployed in our clinical trials as part of our digital transformation. Any unforeseen issues were addressed by exploring with vendors, scouting the market, and finding specific solutions. We did our due diligence and qualified new providers in a short time, thanks to our established feasibility process during the piloting phase. Now, these solutions are available for the studies to use.

Another solution we looked at is the remote SDV/SDR. Although it is not part of my team’s scope, we started to look at how we can do this remotely. This activity is usually conducted at the site by the site monitor. Due to the pandemic, many of the regulatory agencies have now allowed this to be performed remotely. We started to investigate with our providers how we can deploy this as it is a critical activity, especially when we need to complete a database lock, and verify and clean the data.

Some of the challenges are applying the solution in mid-study. Although it sounds simple, we have many considerations, such as regulatory acceptance. A lot of our clinical trials are global studies, so we need to understand each country’s regulation and also to assess any changes to the protocol, updates on informed consent forms, changes to the risk management plan and the monitoring plan, changes on the way the data has been collected, stored, and even analyzed. This is all critical because we’re changing from the traditional way to a remote method; we need to ensure everything is documented correctly and assess the risks. With this contingency plan, we can minimize the impact on sites and participants during this pandemic. Also, it will support future situations like this, including natural disasters.

I want to highlight that studies that were not affected significantly by this lockdown are studies that already implemented full decentralized clinical trial (DCT) solutions. They have telemedicine solutions, including remote assessments.

MA: How did you leverage existing processes in piloting to implement DCTs?

DLC:As part of UCB’s digital business transformation, we have already been exploring and piloting different solutions to bring trials to patients’ homes. It includes DCT components like telemedicine. With this pandemic, the sites needed support to continue to monitor patients’ safety. This is where we looked at the current vendors and any enhancements they made on their solution. One example was a vendor who provided a way to capture the electronic patient-reported outcome (ePRO) at the site. We worked on the solution to provide this to be web-based so participants can complete it at home.

We also worked to allow assessments to be collected using the interviewer mode, where the investigator can connect with the participants to have them complete the assessments via a phone visit or televisit (videoconference), rather than them going into the site. We started to pilot these two solutions (ePRO and televisit) in two studies and then roll this out for the others. Having invested in piloting DCT models, we were able to efficiently implement them during the COVID crisis. 

MA: How has the pandemic changed the culture of innovation at UCB?

DLC: Our Development Solutions team has been undergoing a technology transformation implementation for the past several years. The silver lining of the pandemic is that it has accelerated implementing innovation in general and in DCT. Either the full version, the entire virtual, or the hybrid model, we call it the virtual sites or virtual visits. I have seen a mindset shift towards implementing innovative solutions and DCTs. Teams realize the importance of adopting remote solutions and being open to finding new solutions that might resolve the problem. Again, it’s just adapting to new ways of working. Overall for us, DCT adoption has increased by 400% in our trials, and we’ve been supporting new studies that are coming along. To elaborate, we evaluate how we can conduct the trial remotely by creating value for patients, reducing the burden, and providing flexibility - where we bring the clinical trials to the patient’s home rather than patients having to travel to the site. Providing options and catering to the needs of the participants and having a mindset of patient centricity are key in today’s environment, where patients expect services to be centered around their lives.

MA: Has COVID made a difference in clinical operational execution at UCB?

DLC: Yes, I think so. The clinical operations teams have always been open, but sometimes there might be hesitation if you’re the first one implementing something new because there are new challenges to overcome and a lot of planning and preparation, including how to ensure regulatory acceptance. So for me, the new model is working with regulatory agencies when we’re trying to implement some of these innovative solutions in an agile manner, also receiving feedback from our participants and sites to create the value for patients and ensure that we can bring the right solutions to a study by reducing the site and patient burden. With the current guidance that the regulatory agencies have provided to the industry, we’ve seen some flexibility where in the past, we were not able to do some activities remotely to now being able to do so. I hope that we continue to operate in this manner. This is something that I am passionate about, especially thinking about innovation, bridging with science to speed up the drug development process.

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.