Global Clinical Trials and In-Home Visits: Preventing Common Pitfalls
Why there has been an increase in at-home visits for global studies and how to sidestep some of the biggest challenges.
Firma’s director of clinical operations Nikki Skirvin was recently interviewed by Outsourcing Pharma where she discussed everything from the pandemic and protocol compliance to study team advice for global clinical trials with a home trial visit component. This article contains more of her perspectives on how to tackle some of the challenges that come along with running multinational studies. You can also read the interview on Outsourcing Pharma here.
The COVID-19 pandemic has changed many things within the clinical trials space including the accelerated adoption and integration of at-home visits. Many sites were working with reduced staff or closed entirely. Patients were uncomfortable traveling to sites and coming in contact with too many people and risking COVID-19 exposure/infection. Some regions of the world were in complete lockdown and patients were restricted from traveling to sites entirely. Home trial visits became a critical gap measure that kept ongoing studies running and provided continuity to patients across the globe.
As pandemic restrictions slowly lifted, the conversation shifted from “what emergency action can I take to keep my trial going?” to “how can we use home trial visits to benefit patients and sites for new protocols?”
Here are some of the top challenges study teams face managing global clinical trials today and solutions that can help create a more streamlined and efficient study.
In addition to the country- or region-specific health authority requirements, global clinical trials also need to comply with privacy regulations that can vary from country to country.
For example, the European Union’s General Data Protection Regulation (GDPR) often requires more stringent restrictions on how personal health information (PHI) and personal identifiable information (PII) are handled.
Firma has supported studies in more than 45 countries and tackles most challenges with a combination of sound infrastructure and decades of experience. But we also have a data protection officer based in France and several global partners that provide regulatory updates for each country as they arise so we can be continually responsive to regional regulatory requirements.
Navigating the evolving intricacies of GDPR and applying that information to how global study visits are performed requires dedicated resources and a willingness to be proactive.
Protocol Compliance & Cultural Climate
One of the top benefits of at-home visits for global clinical trials is their significant positive impact on compliance. Patients are more compliant when the home trial providers are visiting them in their homes, and they are more likely to remain in the trial longer if they continue to have the option for at-home visits for the duration of the study.
Both the quantity and quality of protocol compliance are enhanced when home trial visits are utilized. However, US-first global studies can run into a few protocol-specific challenges when it comes to at-home visits.
Some countries require a specific level of expertise to complete certain types of visit activities such as nursing assessments or administration of investigational product (IP). These restrictions limit the types of activities that can be performed during a home trial visit.
For example, despite Firma’s ability to safely and successfully administer IV infusion of IP during at-home visits in the US, some countries consider the activity too complex to be completed in the patient’s home. Additionally, some procedures require specialized equipment that may not be portable or may be prohibitively expensive. And some cultural or social norms can limit or even prevent people from participating in-home trial visits, effectively eliminating it as an option entirely.
Engaging with and including an internationally experienced home trial services CRO as early as possible is the only way to prevent these regional variations from delaying the visit schedule. While Firma has been brought into studies at just about every stage, the most successful are the ones where our team is able to fully understand and even collaborate on the protocol requirements and visit schedule well in advance of the first patient visit.
Recruiting, Training & Management
Home trial providers are essentially an extension of the site so selecting, training, and managing the home trial team of caregivers is of the utmost importance for global studies.
Firma works with sponsors during trial start-up to determine what home trial provider qualifications should be required and then creates a comprehensive trial-specific training program based on the protocol, central laboratory manual, the CRF, and our extensive field experience. Firma team members lead the intensive training program, not outsourced trainers, and each individual home trial provider is required to pass a protocol comprehension exam to ensure they understand all protocol details and the expectations for each at-home visit. (Firma trainers are also available by phone or teleconference during visit execution to answer questions or help troubleshoot any issues that may arise for the home trial providers.)
A home trial services CRO should be working with trusted national and global partners to source home trial providers and provide the PI with their CVs, licenses, certifications, and training records for approval before any home trial visits are completed.
While Firma manages the burdensome tasks of recruitment, training, and management, we also encourage PIs to meet with the home trial providers pre-visit via phone, teleconference, or in-person if distance allows – an optional way for PIs to engage in a deeper level of communication and collaboration that can be especially useful for global clinical trials.
A Modern Approach to Global Visits
Lowering the barrier between potential research participants and a site’s recruiting clinical trials is not a challenge specific to just one country. Studies desperately need to improve patient enrollment, engagement, and retention throughout the world, and accommodating the needs of the modern patient requires very personalized service.
Bringing the protocol visits to the patient:
- reduces or eliminates a significant burden of participation (e.g., frequency and distance of travel),
- expands the potential patient pool geographically and allows for recruitment to be inclusive of patient populations that would normally be unable to participate (e.g., patients with mobility issues or rare diseases, etc.),
- allows sites to conduct more study visits while the home trial visits are occurring,
- reduces administrative burden for the visits completed in the home, and
- positively impacts timeline adherence, trial costs, and results.
The needs and expectations of the global population have shifted. The associated shift within the clinical trials space needs to be more than just temporary if we want to successfully bring treatments to the people that need them the most well into the future.