The COVID-19 pandemic has upended clinical trials for pharmaceutical and life sciences companies. The shift has caused companies to rethink the traditional study delivery model to incorporate virtual elements such as remote monitoring and, in some cases, a decentralized approach where fewer visits are required at the traditional trial sites and can be done more locally.
HRI spoke with PwC principals Benjamin Gill, Claire Love, Sean Rooney, and Ian Shafer as well as director Jon Shephard about how PLS companies are adapting to the change, whether it is temporary and what the opportunities are for other stakeholders, including contract research organizations, private equity firms and digital tech companies.
How much has the COVID-19 pandemic changed the state of play for the conduct of virtual or decentralized trials?
On a macro level, it’s greatly accelerated. In general, our industry is slow to adopt new technology. Before, some companies would take a pilot approach to see how a decentralized trial or a study with some remote or virtual elements might work across different therapeutic areas. With COVID-19, it’s kind of forced the hands of everyone. Not necessarily to decentralize, but to assess whether you stop or could continue with more virtual visits without impacting the quality/integrity of the trial.
I agree. COVID-19 forced sponsors to adopt some of these practices because patients couldn’t come to hospitals or other trial sites for their specified visits. Longer-term sponsors are going to adopt these approaches at scale in many disease areas to protect against disruption from future pandemics. The ability to deliver trials through virtual and decentralized models will be a necessary business continuity strategy because if this happens again, we can’t have trials grinding to a halt.
HRI: What about long-term adoption? Do all trials and sponsors now shift to incorporate these elements in their study conduct? Will it continue to be gradual but at a faster pace than before?
In speaking with sponsors, there’s a desire to maintain some of these models that have been put in place because they feel like they may improve patient engagement and could be more cost-effective. However, there is a general concern that it may be challenging to gravitate away from the operating models of traditional clinical trial execution that have been so invested in by sponsors, CROs and technology companies that enable trials. The willingness of patients to enroll into studies as COVID-19 continues will likely be a key determining factor on the pace of change.
Sean Rooney: The traditional model is not going to go away completely. The model will continue to include academic medical centers and large health networks for strategic reasons. Where the virtual and decentralized elements start to come into play is with chronic diseases that require large trials such as diabetes and cardiovascular conditions. PLS companies don’t have a strategic relationship with a lot of these investigators, and that is where decentralized trials could see uptake.
Ian Shafer: I think you could have some elements where companies use the traditional brick-and-mortar sites but add a few “decentralized” sites to put their toe in the water and evaluate the challenges and opportunities. I think we’ll see that gain popularity because you can’t suddenly make a trial virtual or decentralized; it takes planning at the study design level, and they may not have the technology in place yet. I think that the more severe conditions, such as cancer, will look to virtualize some components but not all. In non-severe, chronic diseases, there will be a greater adoption. Not all therapeutic areas are created equally in these new models, and the type of the disease and severity will impact it.
COVID-19 forced sponsors to adopt some of these practices because patients couldn’t come to hospitals or other trial sites for their specified visits. Longer-term sponsors are going to adopt these approaches at scale in many disease areas to protect against disruption from future pandemics. The ability to deliver trials through virtual and decentralized models will be a necessary business continuity strategy because if this happens again, we can’t have trials grinding to a halt.
HRI: Our consumer survey found that patients would be more willing to participate in trials that included some element of remote technology. What are the benefits for virtual and remote elements of a study?
Sean Rooney: These virtual or remote elements in a trial are more patient-centric. If a person has an average two- or four-hour drive to get back and forth to the clinical site, they would love to do more of these trials locally. But if they live in New York City and can go to one of the institutes in the city that runs the trial, the patient can choose their own journey.
It could be better, cheaper and faster because it could allow better access to the patient more quickly, reducing timelines for enrollment and other issues that contribute to costs and delays.
Benjamin Gill: If you can cut that long drive down to just once or twice per month (or even less) rather than weekly, the patient benefits and may be more likely to participate in the trial and not drop out. Also, there is the consideration of personal risk of contracting COVID-19 by just being at an investigator site, which may inhibit the desire of someone who is interested in participating in a study.
HRI: You mentioned CROs. Are the perspective and adoption of virtual study elements different for contract research organizations than a biopharma company?
Benjamin Gill: CROs really wrestle with this tug of war where theoretically they may be able to execute trials faster if it’s done with some virtual or remote elements, and the volume should go up and it will help from a profitability perspective. But fees for monitoring, project management and others—do those go up or down in this trial model? There may need to be a further assessment and revisit of the contracting model between sponsors and CROs that would further enable the adoption of virtual study elements.
Sean Rooney: CROs are trying to back into this with partnerships and vendor networks for these decentralized trials.
HRI: What are some of the capabilities companies may need to add to enable these virtual elements in trials? Will deals and partnerships play a role?
Claire Love: I think it becomes a question of what capabilities they need to have and who the owners of those capabilities are. It’s not necessarily that pharma companies need to or should own these capabilities. They can—and likely should—outsource to others to access best-in-class capabilities.
In terms of potential partners or collaborators, it’s predominantly technology companies with major platforms. There’s also remote monitoring technology, recruitment, enrollment and consenting tools, and then the clinical management of that data and a dashboard to see it. You can partner around these technologies.
But there’s also the logistics of how to get the technology in place. Do I need to add home nursing capabilities? Rather than shipping to 10 sites, there’s the logistics of shipping to 1,000 people and doing that in a double-blind fashion—how will that work?
Benjamin Gill: Home healthcare companies rapidly became an important participant during this time to maintain patients enrolled in clinical trials. Their operating model was not tailored specifically to support clinical trials, but the key elements are there. They may now look at their model and optimize it for clinical trials, resulting in becoming an important stakeholder going forward.
HRI: Are there other target audiences beyond PLS companies that could benefit from increased uptake/implementation of virtual clinical trials?
Claire Love: We think it creates an opportunity for private equity [PE], because we already see this tail wind around virtual trials, with COVID-19 accelerating that. Virtual and decentralized trial elements could be an exciting growth platform. Even though it’s small, there is sufficient growth, with assets available that private equity can make investments and help to scale that as more of the industry expands into virtual and decentralized trials.
Jon Shephard: PE has historically invested heavily into pharma tech and e-clinical solutions, like eCOA [electronic clinical outcomes assessments]—those assets provide a nice mix of technology-driven growth and pharma fundamentals, but without taking on R&D or single-asset risk. Now that that space is starting to mature, we’re seeing a lot of interest pivot to virtual trials and other newer modalities. Even if they remain small, you can get a lot of growth if this goes from 1% to 5% of trials that are run.
Beyond “direct” investments into the space, we also see interesting opportunities around some of the enabling services. Many PE houses are very comfortable around home nursing services, logistics, packaging and other more “established” healthcare investment areas. We see virtual trials as an interesting growth vector for these types of businesses; it won’t be their core offering, but it could provide a helpful boost.
Partner, Pharmaceutical and Life Sciences
R&D Advisory Services, PwC US