COVID Shifts Clinical Innovation in Big Pharma

COVID has caused many study disruptions, and the clinical innovation investments that big pharma companies put in before the pandemic are now coming into play. The concept of clinical innovation has changed, as have cultures on adopting clinical innovation. In this interview, Hassan Kadhim, Director, Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at Bristol Myers Squibb, will discuss his perspectives on how the pandemic has shifted clinical innovation.

Moe Alsumidaie: How has COVID impacted the clinical trial environment?

Hassan Kadhim

Hassan Kadhim: When COVID began emerging, it impacted the workforce because we could not meet in person and collaborate with our stakeholders and designing studies and in planning for study timelines. From logistical and organizational perspectives, it has already affected the pharma industry and many different industries. As a result, there was an adaptation going from in-person schedules to fully remote collaboration for a long, sustained time. But on top of that, where it impacted clinical research the most is the patients. First of all, healthcare institutions, especially at the peak in March and April, were getting overwhelmed with COVID cases. Suddenly, what we observed was that the hospital networks had to rightly prioritize the acute crisis by treating COVID patients and patients suffering from life-threatening diseases rather than from other indications and conditions.

For clinical research, patients started thinking twice before going to the sites, which created the situation for us in pharma to find solutions and quickly address recruitment, enrollment, and retention. Despite that, many pharma companies put a halt or a pause to their clinical research portfolio, which has delayed many study starts, study enrollment, and forced everyone to rethink what we can change to adapt to this new environment.

MA: What was that experience like internally?

HK: They say necessity is the mother of invention—and by the same token, innovation. COVID has created the necessity for innovation. It has forced everyone to think differently because the entire environment around us has changed, and we all realized that clinical innovation was a necessary tool to enable new approaches for designing and implementing clinical trials. Organizations that had a head start (i.e., they had vital clinical innovation programs, had experimented in many different approaches and technologies, whether it’s decentralized trials or remote monitoring, or really anything that in the past (pre-COVID) was considered maybe a nice-to-have at the time) experience an easier transition to the recovery efforts compared to organizations that did not invest in clinical innovation. 

Nonetheless, for everyone, this experience reinforced and emphasized the need for innovative trial approaches as it really came down to portfolio continuity. If you want to continue doing clinical trials, you likely cannot continue doing them in the old paradigm and ignore the impact of COVID-19. Maybe you can do it for some sites, for some regions, but on an enterprise level, on a global level, knowing that the pandemic was a global occurrence, we noticed a varying degree of impact in different countries and different regions.

MA: What is it like for managing in-person visits, say from patients to monitoring visits?

HK: When there are surges in COVID cases, you will find that patients will have the valid question come back to their minds: “Should I go to my clinical trial visit? Is it that important? Should I risk myself of being infected?” So, anything that enables patients to participate remotely will be critical. Anything that allows the transfer of data directly from the electronic source (i.e. eSource) will be a difference-maker. Remote monitoring has also become increasingly important; CRAs, for example, may be asking: “should I go to the site and expose myself?” or, “can I do monitoring activities differently or remotely?” If we enable remote monitoring, that could also be a difference-maker from an efficiency perspective for running trials. When we are forced to think about how we adapt those components to enable clinical research, we will likely see that the long-term impact of the COVID crisis may be further adoption of innovative trial approaches and hopefully sustaining that kind of flexibility in clinical trials to drive real change.

MA: What kinds of technologies are now in demand to be used in clinical trials?

HK: Anything that enables patients to participate remotely, providing flexibility for patients to be in the trial. We noticed that with COVID, many sites, especially big institutions, have now adopted eConsent as a platform for trials that they conduct. This was also in some cases a mitigation measure in a pandemic to keep trials running. To emphasize, this is the site adopting eConsent, not the sponsor pushing eConsent to the site. We realized many sites are not only interested but are going full-blown implementation with eConsent in their practice. As a sponsor, it’s time for us to consider eConsent as a commodity and not an innovation, and address working with sites that have eConsent versus those that don’t and how do we create this ecosystem, where multiple eConsenting modalities are all considered valid is something sponsors will need to adapt to.

The same is true for telemedicine. We know that several healthcare institutions were already using telemedicine in their familiar healthcare setting, but now the necessity created with the pandemic brought an immediate need to use telemedicine in their clinical trials as a mitigation measure. Some sites already had telemedicine solutions; others didn’t. Sponsors are thus left with the optionality of using the site’s own telemedicine technology, or push telemedicine as a solution to the sites. I think a flexible ecosystem is probably the happy medium we as an industry need to strive to, where the site will use their own telemedicine platform when available and get the sponsor’s telemedicine provided solution where the site doesn’t have one available. And all of that in the same study! This “trial-with-options” mantra is where we need to adapt to as an industry.

And then, of course, it raises again to the forefront the approach of decentralizing clinical trials, so allowing a fully remote approach in some cases or a hybrid in other cases, or just a flexible model where for the majority of visits in a study, the patient has the choice to do the visits in person at the clinic, or remotely using technology.

MA: How has COVID changed the culture of adopting innovation in big pharma?

HK: I'm sure you probably know about the innovation adoption life cycle, where whenever there's some innovation that's introduced in any industry or any market, there's usually the innovators that introduce it, then there's the early adopters, the early majority, the late majority and then the laggards. If an innovation is really good and provides real benefit, with time everybody adopts it and that time could take months to years, but it's generally a question of time. I think what COVID did, is change the culture of innovation, where for some of these innovations, we were probably in the pharma industry at a stage of, having a good portion of early adopters, but the early majority hadn't really joined. What COVID did is it pressured the system so much that it accelerated the transition from early adopters to early majority. By the same token within clinical innovation, there has been a culture shift towards accelerating many of the innovations that were in the pipeline to help us prepare for the future. I think this is the cultural shift that everybody recognized is needed to mitigate the very real (and now realized) risk of disruption of clinical research due to a pandemic. The rest remains on us as an industry from a tactical perspective and change management on implementing and enabling the adoption those innovations to work for our studies, sites, and patients. There’s still much work to do, but what changed is the perception of the culture and its sentiments.

MA: What will clinical innovation look like in the future?

HK: Innovation means different things to different people, and what’s an innovation today, may no longer be called innovation in 10 or 15 years (or less). For example, EDC, which 20 years ago, was the innovation of the hour is now a standard technology that is essential for every trial. I think what COVID has done is that it propelled all the things that we call innovation today in 2020; it has accelerated their trajectory to no longer stay in the “innovation” category for too long. In the future, I think that decentralized trials may become the norm in the industry. Post-COVID, I think there will still be innovations that perhaps we haven’t thought of today.

I think when the dust settles and we as a society come out of this pandemic, we will look back at this period as a period that really pressured everything to accelerate the innovation of its time (for many different industries).

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.