The COVID-19 pandemic has wrought havoc on global supply chains in nearly every industry. Professionals in the clinical trial field are finding that the virus is challenging the way they move around one of their most important resources: patient participants.
Outsourcing-Pharma (OSP) recently spoke with Rob Laurens (RL), principal of RSG Services for BBK Worldwide about how clinical research sites and sponsors can address the travel-specific challenges created by the virus, keeping trials going while preserving patient and staff safety.
OSP: Before COVID-19 hit, did clinical trial professionals typically have contingency plans in place, in case of a catastrophe?
RL: Well, to be fair, let me first say that I think the current situation is unprecedented – not so much in it not being a type of “catastrophe” that sites, CROs, and sponsors generally do plan for, but rather in the unique and widely varying manner in which sites have had to respond. This is true not only by site, but also, for some sites, by study.
Some sites have needed to pause a given study because travel for the patient would involve a level of risk of contracting COVID-19 that the participants shouldn’t take on, based on their current health.
At the same time, the site may decide to proceed with a different study despite the risk that travel poses for patients, simply because it’s riskier for the patients to not proceed with their study care. You can quickly see how there may be myriad scenarios that need to be individually addressed by sites.
And then, on top of all that, the travel landscape continues to change rapidly, and not always in a manner progressing toward less concerns, restrictions, or limitations. For example, even though a site may be “open,” a region or country may be on lockdown, which can significantly limit hotel and ticketed travel inventory, let alone patient travel in general. In some countries, it now varies by town whether or not residents may leave or return from their town, let alone their country, without special exceptions being arranged – this, after patients recently were able to travel by ground during the pandemic within their country to their study sites without problem.
So, were there specific contingencies in place for the current pandemic? I think different sites, CROs, and sponsors had contingencies in place that were applicable for some of the scenarios, but not in a blanketed way that allows their studies to move ahead unimpeded amid the ever-changing landscape of COVID-19.
OSP: What are the primary hard lessons sites and sponsors have learned since the pandemic hit?
RL: Well, from a patient experience standpoint, I’ve seen some sponsors flummoxed when patients simply refuse to continue study participation because they don’t want to risk possible exposure to COVID-19 – regardless of the lengths to which the sponsor is willing to go to get them to and from the study visit safely. Not that the sponsors didn’t already perceive and approach their participants with a patient-centric partnership, but a flat “no” is not something they encounter en masse, typically.
And, I think there’s been an eye-opening realization of how interdependent clinical trial operations are with general business throughout the world. There’s a behind-the-scenes, impervious-to-outside-forces perception of the clinical trial industry that sometimes leads folk to think that the work will march on unhindered despite what more consumer-driven business experience with world events.
So, the fact that all of a sudden patients can’t travel from the EU to the US because flights are cancelled or a government won’t allow entry without extraordinary support services and efforts…that’s arresting for both the study and the study projections.
From a “vendor’s two-cents” perspective? I’d say patient travel and the COVID-19 pandemic offers an opportunity for sponsors to use a company or service that can pivot not only quickly, but also strategically, with expansive, trouble-shooting solutions. A travel company that simply books travel itineraries at the request of the study participant is not well-equipped to get patients where they need to be amid all this international – and even domestic – travel tumult; it can mean the difference between pausing (or even cancelling) a study altogether, and keeping a study going and patients receiving study treatment!
OSP: How has the pandemic changed the way trials handle patient travel?
RL: Everything is subject to change right now; you can’t rely on all the resources, inventory, timeframes, and solutions that you would normally expect. Plus, the wild cards of whether or not sites are open, site staff are available, and patients are willing to travel – each of these is, to a greater or a lesser amount, influenced by how the pandemic is playing out in the regions or countries of concern, whether it’s the country or region that the site is in, or it’s the country or region the patient is traveling from. And this is equally true even if the travel to and from the site is taking place within a given a country.
As a result, sponsors should change their mindset about how to manage patient travel right now, from a request-and-fulfillment model, to one that pre-identifies what each given patient currently needs in order to travel, well before their next study visit. And then, when the time comes to arrange travel for a study visit, verify that the information is still accurate, and implement any and all extraordinary support services necessary to meet those needs; this way there’s an anticipated sense of likely lead time necessary – say, to arrange a visa or special permission to enter a country – to ensure arrangements can be made, and without undo rush and expense.
At the same time, any and all information verified or updated from fulfilling a travel request should be leveraged for any patients and travel requests to which the information applies. In short, patient travel is best achieved through strategic planning and proactive critical thinking.
OSP: What about staff travel—how should sites and sponsors weigh their travel needs in this new world?
RL: Safety has to lead the way, certainly. It makes no sense to undertake any travel that would include undue risk. Sometimes, that’s as simple as doing whatever you can do via Zoom or other means, or as considered as using a professional car service over a ride share or taxi – where there’s greater assurance that the vehicle will be properly cleaned and the driver will be following appropriate health protocols.
It’s really not significantly different from how one should handle patient travel – with the possible exception that sites and sponsors should identify if and when it would best to bring the study to the patient – in other words, sending the site staff to patient’s home, or having study drug delivered via courier to the patient’s home, rather than bringing the patient in for, say, a treatment-only visit.
OSP: What are some solutions trial teams should consider to help minimize travel?
RL: Remote study visits and bringing the study to the patient when possible are basic considerations. When the patient is making a great effort to attend the study visit (whether “great effort” is defined by geographic distance, complexity of travel, limited travel inventory, and/or physical and mental toll on the patient), time and again in these past few months we’ve seen it prove wisest to temporarily re-locate the patient to be highly proximate to the site for as long as is feasible – even if that means for the duration of the remaining participation.
We’ve seen patients not be able to travel for an essential study visit suddenly because a country stops allowing commercial flights in or out. We’ve seen patients flat out refuse to travel for study visits until the temporary relocation option is offered – even when the sponsor is willing to charter private air transport.
Best advice: get your patients where they can participate safely and keep them there for as long as is feasible for everyone. It’s worth that effort, because the efforts you will go to to get patients back and forth from study visits at this time can be far more taxing – and expensive, ultimately – for everyone involved.
OSP: Could you share any services and resources BBK Worldwide is offering sites to help formulate more effective contingency plans and travel strategies?
RL: At BBK Worldwide, it’s always about strategic thinking, critical thinking, and having options at the ready. We don’t look at providing an itinerary as a transactional commodity, but rather as providing a solution to a problem – even the fulfillment of a travel prescription, as it were.
Our goal is to work with the site staff to ensure that study participation is the participant’s focus, rather than the travel – and, that it’s easy for the site to not only make a travel request, but also to ask for help with anything the patient may need. In fact, we set it up so that, in making the request, the study staff rule out key-but-easily-overlooked details. Plus, our team consults with the site staff to fully understand the idiosyncrasies of an individual patient’s need, developing a considered approach for each patient that continues to inform travel arrangements and decisions throughout the patient’s participation.
For example, is a patient who uses a wheelchair bound to the chair, or are they able to get themselves in and out of a car? If they use an electronic wheelchair, do they always use it, or can they use a manual chair when their accompanied by a caregiver? What do they prefer and why?
All these questions, in consult with the site staff who understand their medical needs, restrictions, and personal capabilities, produce the best experience for the patient – not to mention the site staff, and even the sponsor, as going to this level of concern inevitably saves travel budget.
It’s an everyday thing for us to ensure the patient has the right hotel room for their needs, the best itinerary timing for their health, the wheelchair and bed lift they need, or the travel ambassador/interpreter who can advocate for them, etc. These days, though, with COVID-19, we are including our special services on a more regular basis – for example, services that enable sites to conduct remote visits, to send staff or study drug to the patient, to provide travelers with visa or entry restriction exemption authorizations, to establish and manage an effective long-term stay plan, to customize an itinerary around a patient’s concerns and comfort level with traveling by one mode or another.
It’s all stuff that we have always done, whenever it was needed; it’s just that COVID-19 has exponentially increased the need for these services.
OSP: Can you envision a site- and travel-free clinical trial industry in the near future?
RL: No, I don’t think so. I’m not a healthcare provider or a study participant, but it seems to me the real motivation to participate in a given study is in large part tied to the expert care that the patients receive – inclusive of the human contact that goes into it. Maybe there’s a way to convey that over the web, but it will likely be less attractive to patients who are truly struggling with a condition – though, I guess that depends on the condition, let alone the study.
Of course, if we don’t have a solution to the pandemic anytime in the coming year or two, then that’s a different story.
OSP: What else would you like to add?
RL: As unpredictable and problematic as these times are for clinical trials – not just travel, but all aspects of the industry – it seems to me that there is an unprecedented opportunity for the industry to radically improve how it operates with regard to adoption of innovation. There’s kind of a profound irony experienced by clinical trial support companies: in vetting vendors for selection or preferred status, sponsors require that companies embrace and fulfill a commitment to continuous innovation, which is a sound business construct.
However, generally speaking, in practice sponsors are remarkably slow to adopt new technology, methodology, and even conceptual understanding of the patient experience – especially if an innovative idea emerges mid-contract. It’s not a deliberate thing; it happens because the clinical teams have so much – too much, sometimes – to juggle. But with the pandemic, however, there hasn’t always been that luxury. In a sense, always playing it safe isn’t always safe for people right now.
The good news is that, so far – at least in my area – I’ve only seen good things come from a well-thought-through, let’s-try-it-and-see approach to problem solving. I’m not saying sponsors should try every new, shiny idea or technology, but learning how to leverage critical thinking, rather than comfort and familiarity, with regard to continuous improvement of services throughout a study – we all have a real opportunity to make that a new standard operating procedure.