Successfully shifting to decentralized clinical trials requires more than just plucking all the ingredients of a study and plopping them into patients’ homes. Launching DCTs or transitioning to the decentralized format requires a solid strategy, knowledge of what it takes to source mobile research services, and more.
Recently, Outsourcing-Pharma connected two DCT experts to talk about home-health and mobile research services, and how to wrangle with the intricacies of such resources:
- Krista Bradley, vice president and general manager for IQVIA Research Nursing and Phlebotomy Solutions
- Chuck Drucker, head of decentralized trial solutions, Q2 Solutions
OSP: Could you please talk about some of the key challenges that trial teams face when designing and executing a decentralized study?
KB: Decentralized clinical trials, or DCTs, are not a one-size-fits-all approach. Every trial setting and patient population has unique needs, and the DCT model must be customized to accommodate those needs and ensure success. That complexity can raise some challenges, making it necessary to plan for and review these potential issues up front with sponsors.
Before diving into the protocol specifics or patient population needs, we have to understand the regulatory landscape across the sponsor’s targeted geographies. For example, in some countries, nursing licenses are owned and managed by hospitals, which makes sourcing independent nurses for home health or mobile research services more challenging. This is where experience in assessing feasibility and designing the trial can be critical for success.
Once we have a sense of the regulations at play, sponsors and clinical research organizations (CROs) can then dive into the patient population – their needs and preferences – as well as protocol itself to identify which study visits are most suitable for remote visits and what decentralized tools are most appropriate to use.
For mobile research purposes, at IQVIA, our Research Nursing and Phlebotomy team performs a feasibility assessment, ensuring that requested visit types are within the clinicians’ scope of practice and can be completed remotely. A screening visit, for example, typically requires physician involvement and is done at the site due to the complexity. Procedures like checking vital signs, ECG, labs, and the administration of investigational product translate well into a remote visit.
We also need to ensure there’s ample time to support training and to secure equipment and supplies so the mobile research teams can successfully perform the remote study visits for patients. Ultimately, the goal for sponsors and CRO partners is to make the experience as seamless as possible for patients, the site staff, and the principal investigator and to ensure data is captured accurately and with quality and in a timely fashion.
Lastly, it is key to engage sites in this decentralized clinical trial journey. We are seeing how remote study teams can become extensions of research site staff, which is a big benefit to sites that are resourced just at or below capacity. Sites need to better understand the value DCTs may provide towards their work and their staff, and CROs need to gauge site needs and perspectives when designing DCT approaches to strengthen collaboration across the study team from recruitment to database lock.
OSP: What questions do sponsors need to ask and what kinds of decisions do they need to make around how to handle lab collections?
CD: When utilizing a decentralized approach to specimen collection, there are a variety of patient burden and operations-related factors to consider.
From a patient burden perspective, study teams must decide which specimen collection visits (all or some) will take place at investigator sites, patient homes, or alternative locations like a retail store, patient service center, pharmacy, civic center, etc. If a collection requires multiple time points, study teams must consider how practical it is to be at a patient’s home for a long period of time.
Some tests require centrifugation or incubation, which mobile care companies can accommodate. However, not all mobile research teams are trained to work with pediatric patients, so, the patient population needs consideration too.
Sometimes additional patient support may be needed prior to, during, or after the DCT visit via the site staff or other personalized support. That might be offered in the form of reminders of home visits and dedicated time for managing visit expectations.
From an operational perspective, the cost of a specific kind of DCT visit versus the benefit and the procedures required during the visit must be considered. The required procedures impact the type of healthcare worker needed and the cost.
Sample stability and transit time from the patient location to the lab must allow the lab to test a sample within the stability window for each sample type and test. And, study teams must consider the impact of using visit and site-specific kits, which help minimize manual data entry errors. This is compared to using generic kits, which require nurses to write the investigator and visit on requisitions and labs to manually move accessions to the correct investigator and visit.
While some study teams opt for generic kits because they believe they will reduce kit wastage, other study teams opt for the traditional visit and investigator-specific kits to minimize the chance of human error.
OSP: Could you please share the benefits associated with turning to mobile research teams to handle lab collection?
KB: Patient centricity is the biggest benefit to integrating DCT solutions like mobile research teams to handle lab collections and more. When designing a trial around the lives of patients and sometimes even their caregivers, we need to ensure minimal disruption. This is especially valuable when a visit requires something that can more easily be shifted into a remote visit such as vital signs collection, questionnaires, and specimen collections for blood labs, etc.
By reducing the burden of participation through these DCT solutions, we can make trial participation more accessible and acceptable to a wide variety of patients in a broader geographical area. As important, we are also able to make trials more accessible and inclusive of traditionally underrepresented populations, helping to improve diversity in clinical research.
Strengthened patient-centricity translates into benefits across the clinical trial process. By making it easier to participate, there are fewer protocol deviations because common logistical situations that cause patients to miss a visit such as lack of childcare, work conflicts, or transportation issues can be avoided.
COVID-19 has really underscored the value of flexible, scalable DCT models. These approaches were critical to ensuring important research continued through the pandemic despite lockdowns and travel restrictions.
OSP: Then, what are some of the potential negative points with using mobile research clinicians?
KB: We’ve seen how DCTs utilizing mobile research teams are effectively addressing quite a few common challenges in clinical research. The potential areas for concern regarding the integration of DCT solutions are not much different than what you might encounter in a traditional site-based clinical trial.
For example, on a rare occasion, a nurse may experience an equipment malfunction, but they don’t have the benefit of running to a supply closet down the hall at the site when they’re at a patient’s home or place of work. Sometimes connectivity or technology challenges could occur, but that is where it is vital to proactively work to plan, anticipate, address, and avoid those potential issues well before the trial starts.
OSP: As you point out, at-home or off-site collection of blood and other samples is an option. Could you please share the pluses, the potential concerns, and what technologies are available to make that self-collection model possible?
CD: The potential for self-collection of bloodwork in clinical trials is viewed as a way to reduce patient burden and potentially improve patient recruitment and retention. The approach is intended to reduce the need for a site visit by patients or remote visit by mobile research teams to collect specimens and potentially add additional measurements to a study due to the convenience.
The potential concerns include regulatory readiness, technology readiness, and process readiness. From a regulatory perspective, not all devices are ready for use in all jurisdictions. Additionally, devices collect capillary blood, but today’s tests are only available on venous blood. However, many companies, including Q2 Solutions, are running feasibility and validation experiments to create tests that can utilize capillary blood.
And, in terms of processes, work is underway to assure self-collection devices can be sent directly to patients and that patients can then receive the appropriate support in utilizing the devices. With that, labs could receive and test samples via these devices in a robust and automated fashion.
OSP: How do study teams ensure the samples are collected and transported correctly?
CD: For site or remote phlebotomy specimen collection, instructions are provided in lab manuals, and personnel are trained on the requirements of specimen collection, processing, and shipment. In some countries, personnel may have an accreditation in order to draw blood samples.
Even with all the best intentions, laboratories regularly receive samples that cannot be tested due to improper collection technique, incorrect use of a tube, incorrect packaging (e.g. shipping at the wrong temperature), etc. Through monitoring and site training, study teams work to minimize these issues.
While self-collection of blood in clinical trials is still in its infancy, self-collection approaches have similarities to site collection around training, monitoring, and remediating. Similar to site or mobile team’s specimen collection, self-collection relies on instructions, training, and monitoring.
In addition, video calls may help assure proper specimen collection, processing, and shipping. In the future, as self-collection of samples in clinical trials expand, innovative approaches to assure sample integrity are under consideration to be built into devices and/or processes.
OSP: Is it possible for the patient participant to not only collect the sample but also analyze themselves, or is that something that may be happening in the future?
CD: Like the companies that are developing self-collection approaches, other companies are developing point of care devices intended to be used by patients at home. To clarify, there is a distinction between “connected devices” and point of care testing, but there can potentially be a fine line between these areas. When we think of connected devices, we may think of step counters, pulse oximeters, thermometers, weight scales, or even ECG devices. Perhaps the area that overlaps the most with point-of-care lab testing is glucose monitoring since this is ultimately a lab test.
Like the work being performed regarding self-collection, a variety of companies are trying to enable lab testing from our kitchen table. The approaches for at-home lab testing generally fall into two main categories: nasal swab approaches and blood-based approaches.
From a nasal swab perspective, several companies have developed COVID-19 tests among other tests to date. There are also blood-based approaches that do not yet have regulatory approval for tests like a complete blood count (CBC), chemistry testing, and biomarker testing.
We will have to wait and see if any of these approaches make it to market. But, if they do make it to market, we, as an industry, need to be ready to adopt the technology, manage distribution, support patients and related data connectivity.
OSP: Do you have anything to add?
KB: We know many sponsors are planning for decentralized trials to be a permanent part of their clinical development roadmap going forward, and we encourage those leaders to consider and plan for a mobile nursing and labs strategy early into the process. When sponsors plan ahead and collaborate with the mobile research team to consider how they are going to vet and leverage mobile visits, they will get the most value from their DCT models and most importantly, patients will be better served by decreasing the burden of trial participation.