As pharmaceutical and life sciences companies begin to rethink clinical trials in the wake of lessons learned from the COVID-19 crisis, a new decentralized approach has started to emerge. In fact, key opinion leaders such as Christopher Austen, director of the National Center for Advancing Translational Sciences (NCATS), are encouraging companies to embrace the change and not return to business as usual after the pandemic subsides.
HRI spoke with PwC principals Anup Kharode and Sean Rooney and director Brian Slizgi about the changes sparked by the pandemic and how trial sponsors could seize the opportunity to redesign the clinical trial paradigm through partnerships with retail- and community-based pharmacy clinics.
Since the pandemic began, how has the situation for clinical trials evolved to where we are today?
The pandemic forced innovative thinking around how to salvage those trials. It accelerated the journey. It may be that some elements will remain traditional, but others may move to a more virtual or decentralized approach.
As an industry, we’re just starting the process to redesign and modernize trials to try to avoid these disruptions in the future. Right now, there is some reprioritization of what to restart and when, but this year, we’re hearing that many pharmaceutical and life sciences companies have declared programs with significant investment to enable decentralized trial strategies at scale. They’re putting money behind figuring out how to do this now. It won’t happen all at once, because we need to make sure they can be done at an appropriate level of quality and compliance without jeopardizing patient safety. But this year, we’ll see some pilots to get at the question of whether we can do these studies at scale through a retail health clinic. If successful, next year we’ll likely see a rapid industry-wide ramp-up in scale.
HRI: What has changed that will enable the industry to adopt decentralized trials at the necessary scale?
Sean Rooney: Until now, the concept of using a retail clinic to conduct clinical trials wasn’t really considered. These clinics will act as hubs within our communities for clinical trials and be the critical enabler of decentralizing studies away from traditional academic medical centers and CROs. We’ve seen attempts with some technologies to make the trial more remote and virtual, but they have not really taken off due to limitations around their utility in only select disease areas and the potential risk around patient safety. Why invest in some of these virtual tools if they’re only fit-for-purpose for two trials a year?
With retail clinics, biopharma doesn’t have to make any significant changes to how they do business, and they can use these more local settings to deliver up to 60% of trial visits each year. That’s because the retail clinic model can serve a lot more disease areas and assess many more endpoints than the virtual and remote approaches.
HRI: What about virtual clinical trials and the industry’s current approach to tackling a virtual trial model? What impact has that model had on addressing some of these key clinical trial needs?
Virtual has been the main method for innovating traditional trial delivery, and a number of startups and CROs have attempted to deliver that in the market. A retail clinic-based trial delivery model takes an entirely different approach: It creates new sites where they don’t exist and brings enterprise scale to trial delivery. This enables access to potential trial subjects that may have traditionally been unreachable by creating trial locations in new geographies, particularly for therapeutic areas that won’t fit a fully virtual model. It is groundbreaking that commercial and consumer-centric retail models can be applied to clinical trials in a way that will significantly impact patient enrollment, experience and retention.
HRI: How has the decentralized model changed or evolved over recent history to make pharma companies more eager to adopt it and allow it to be stickier after the pandemic?
Anup Kharode: It’s really a combination of trying things that haven’t worked and these retail clinics becoming more equipped to manage day-to-day patient care that might be needed in a clinical trial. On the first point, there had been some expectation that at-home visits could work as a way to move away from brick-and-mortar academic sites. But it turned out that patients or trial participants didn’t want the procedures done in their home. Some of these procedures such as infusions can take hours, and individuals do not want to encumber themselves with visitors in their home for an extended period of time. In terms of flexibility and freedom, the retail clinic presents an attractive option for interested participants.
Procedurally, there’s also some simplicity with retail clinics. In order to start up these traditional sites, you’re activating a multitude of sites essentially one at a time.
HRI: Contract research organizations (CROs) have been a major partner of manufacturers when it comes to conducting clinical trials. How may they be affected?
Sean Rooney: Their site management businesses could come under pressure by retail clinics entering the market. I don’t foresee any near-term impact to their core monitoring businesses, and they could even see some uptick in demand in early days. But as more retail clinics are stood up working entirely on digital platforms, this platform could also be under pressure.
Anup Kharode: Nearly everyone is on a level playing field in a decentralized trial model. Companies can go directly to the retailers, and some CROs are considering a move to a more virtualized model and wanting to evolve their business to keep pace.
HRI: What about academic medical centers (AMCs)? What role do they play in this new evolution or modernization of clinical trials?
Sean Rooney: I don’t see them or large health systems being negatively impacted or disintermediated; they are a strategic partner for life sciences companies. If AMCs get on board in partnership with retail clinics, there are ancillary benefits, because it gives them the ability to recruit more individuals into their trials; rather than 25 or 50 per site, they can recruit hundreds. They wouldn’t be doing all of the procedures, but they would oversee and be responsible for them.
Anup Kharode: Additionally, it gives them a wider reach to recruit for investigator-sponsored studies and helps in setting up registries, all of which can provide them with potentially richer, more robust research findings that they can publish on.