The COVID-19 virus has caused unprecedented disruptions to clinical trials around the globe. However, clinical trial sites, sponsors and other stakeholders are seeking ways to continue their crucial work, so that they can keep pursuing much-needed therapies and treatments.
BBK Worldwide, which focuses on patient enrollment and engagement solutions, is looking at ways sites and sponsors can keep trials going, without risking the safety of staff or participants. Outsourcing-Pharma (OSP) talked to Rob Laurens, principal for quality assurance at BBK Worldwide, about obstacles trials face during the COVID-19 era, and solutions that can help surmount them.
OSP: Could you please tell us about the ways in which COVID-19 has disrupted clinical trials?
RL: Its impact is across the board, I imagine, but what we are most aware of are site closures, pausing of site initiations and enrollment efforts, patient reluctance to travel to the study site for their study care, and all forms of troubleshooting and solutions to get study drug and provide study-related care to participants who medically should not pause or discontinue their participation, and/or cannot or should not travel during this pandemic.
OSP: How are sites and sponsors reacting?
RL: Essentially, everyone is minimizing risk for both their patients and their site staffs – whether that’s closing sites or pausing enrollment or limiting the number of caregivers allowed on site. We have seen sponsors take steps that normally wouldn’t be considered – like reassigning patients to a more proximate study site, arranging to have study medication and staff members go to the patient, allowing for some visits to become telehealth rather than in-person. The most progress in problem solving occurs in those discussions where everyone is interested in what the others have to offer. Sometimes it’s the simplest insight that is most salient, but also the most easily overlooked. Cooperation is key right now, as is an agile approach; solutions may need to change as situations evolve – as unsettling as that can be at such times.
OSP: Some sites/sponsors feel that shutting down completely is their only option in many cases. Is that accurate?
RL: I imagine that’s what many may think at first. But really, it’s about examining the competing risks and benefits – and discovering the solutions that forestall unnecessary pauses or closures. That means considering services and support that may not have ever been on anyone’s radar for their study. Typically, there are more options than one might think initially.
OSP: How can shutting down be avoided—what tools and technologies in general can they turn to?
RL: Often, it begins with re-thinking what you already have on hand. For example, for a study where the vast majority of participants do not speak the language of the investigative sites, we rapidly deployed our telephone-based interpreter service that we use to engage with site staffs, to enable investigators to pivot from in-person to telehealth visits. For a brief moment there, because of the language barriers and distances between quarantined providers and patients, I think the sponsor was pretty concerned that they might have to pause the study.
I’m glad you brought up technology in particular. I think technology offers myriad solutions right now – and our industry typically is slow to adopt technology solutions, historically speaking. At BBK Worldwide, we quickly realized that the COVID-19 pandemic is challenging the industry to look for and embrace innovation in a manner and with a speed that it never has previously. Even something as simple as getting iPads to patients so they can Zoom or Skype with the investigator can make a world of difference.
OSP: Could you please explain the Site Support Package?
RL: When facing a problem, a constellation of solutions is what really is called for. The Support Package consists mostly of existing tools and technologies that can be quickly customized to meet the specific demands of the clinical study’s situation. Here’s an overview:
- Site Status Monitoring and Planning:
- Rapid identification of sites’ current and anticipated status for remaining open, closing, or limiting patient visits to exclude study visits
- Impact of local state health guidances on patient travel planning
- Surveys on any needed additional services
- Site-Monitor and Site-Patient Remote Communications:
- iPads and video communication tools
- Medication Transport:
- Transportation of investigational product to patients – or coordination of these requests via TrialCentralNet® (TCN®) if transportation is provided by another vendor
- Remove Study Visit Transportation:
- Transportation of study site staff to patient for remote visits, etc.
- Patient Transportation for Covid-19 Testing:
- Travel support for patients to get tested
- Nurse Call Centers: Augmenting site staff for new / additional duties related to managing participant engagement
Patient Travel and Reimbursement Support
- Itinerary Planning Optimization:
- Review of travel thresholds and reimbursement caps
- Assessment of individual patient schedules for study visits and required transportation optimization
- Impact Planning and Optimization:
- Organizing and spearheading attainment of sponsor corporate directives
- Assessing impact of protocol deviations for the COVID-19 outbreak to the patient experience, and contingency response recommendations
- Study Community Communications:
- Operational and educational communications with CRAs, study sites, and patients
- Crisis management communications
All of these tools and programs have the benefit of being powered by our technology infrastructure, TrialCentralNet (TCN). So, the Support Package is well suited for everyone. Perhaps most importantly, the concept of the Package helps sponsors see that there are more options available to them than they might at first think. A Support Package can include more than what is listed, of course, but it’s a good place to start.
OSP: Could you also tell us a little bit about RSG Arrive—what it is, how it works, and how it benefits site admins/participants/others?
RL: As the name implies, RSG Arrive provides all that is necessary to ensure a patient arrives at their study visit safely, and able to focus on their study care. The sponsor, in consult with BBK Worldwide, set the basic parameters of what can and will be provided through RSG Arrive for each study, based on anticipated needs of the participants. Understanding all that the program can provide, the site staff make a request for their patient that meets with these ethics committee-approved guidelines. Far more than arranging for patient to get to-and-from their study visits, door-to-door, it often includes interpreters, passport and visa assistance, specialty transportation, wheelchairs, short-to-long-term accommodations for entire families – you name it. It can also get study medication and study staff to and from their patients’ homes, amongst other things.
Essentially, we operate our service like fulfilling a prescription. Each request contains what the patient needs, in the medical opinion of the investigator and site staff members, rather than simply what is checked off on a list. Ultimately, the program is designed to ensure that patients have access to the opportunity presented by study participation, regardless of their circumstances – which is, as you know, a stated directive of the FDA and other similar bodies.
OSP: Also, please tell us about Study Ambassador Services.
RL: BBK’s Study Ambassador Services are equally adaptive to the needs of the study, the site, and the patient, offering assistance in whatever way it is needed – interpreters, travel assistance companions, orientation experts for families temporarily relocating to a foreign country during their child’s study participation. Our Ambassadors are selected for their expertise and experience in servicing patients and sites, but they also understand what the patient is generally experiencing, as a person with a particular medical condition. As a result, they are attenuated to the individual’s study-related needs from the first moment they engage the patient. In a very real sense, they too, like RSG Arrive, fulfill the sponsor’s commitment to providing access to the care offered by study participation; they make it possible for patients to overcome barriers that are not logistical, but may be just as daunting – if not more so.
OSP: Finally, do you think COVID-19 will have long-lasting/permanent impacts on how clinical research is conducted?
I think it already has. It’s forcing sponsors to challenge themselves in at least five key ways:
- Sponsors need to establish an enrollment agility to manage closures of some of their sites – identify all the options and support services for enrolling more at those sites that remain open.
- Sponsors need to maintain participant engagement now more than ever. Many patients will be looking for the guidance of their study site staffs, and there is much sponsors can do to support both sites and patients in this regard.
- Sponsors need to embrace technology and innovation. What was previously perceived as “risky” now needs to be seen as de-risking – virtual visits, medication transport, creative travel solutions are all examples of this.
- While at the same time that they’re doing everything they can for safety and health, sponsors need to be preparing for what will be needed after studies begin returning to normal.
- And, sponsors need to be ready to ramp up enrollment quickly post the COVID-19 lockdown.
Technological solutions also will take root and become mainstays in study conduct. Study visits are not all going to be happening in the doctor’s office, now that the efficacy of telehealth will be firmly established for clinical research. In turn, this will open doors to other technology innovations such as smart device apps. Apptomics, for example, has an app that provides highly accurate remote monitoring of patient response in movement disorder studies. Closer monitoring without having to take up site staff time means more capacity for focusing on rapid enrollment, and thus speeding treatments to market. The industry is going to want more of that, undoubtedly.
Lastly, more attention undoubtedly will be paid to contingency planning across the board. That’s the best and most adaptive response, I would think. As serious and pervasive as this crisis is, a best hope coming out of this would be a ready embracement of adaptive innovation in all aspects of clinical research – not only that we rise to the demands of the hour, but that the demands of the hour raise our expectations for ourselves in preparedness, problem-solving, adaptability, and responsiveness.