Virtual trials promise to disrupt the clinical research environment, allowing patients to participate in trials from their homes using wearables, telemedicine, and treatments shipped right to their door. But virtual trials are not a one-size-fits all approach. Every trial setting and patient population has unique needs, and the operational format must be customized to accommodate those needs for a trial to be successful.
The industry is still in the early days of adoption, but as we delve into this space, three core virtual trial models have emerged. Each of these models offers time and cost savings for sponsors and patients, while addressing the unique quality, safety, and performance requirements of the trial setting.
- All virtual
- Hybrid Models
- Virtual and Site-Based Arms
Fully virtual trials, in which patients never have to visit a physical site, offer potentially huge time, cost and recruiting advantages.
Investigators can run an entire trial from a single site, reducing site overhead, and expanding recruiting to anyone in a broad geographical target population. This accelerates recruitment by eliminating the travel burdens that patients often cite as a reason for not participating. It also makes it possible to work with a more diverse patient population who may not have access to traditional trial opportunities.
Once the trial begins, investigators collect much of the data via wearable devices that send hundreds of bits of information about the patient’s condition daily, adding quality, quantity and consistency to the data gathering process. This makes it easier for investigators to track treatment trends, identify cause-and-effect scenarios, and more proactively pinpoint adverse event scenarios.
Physician visits are connected via telemedicine and trial data are collected electronically, which is less time-consuming and disruptive to patients’ daily schedules. If patients do require in-person assistance, they can leverage home health visits or local healthcare centers that partner with trial sponsors to meet their needs. This format makes trial participation much easier for patients and reducing attrition.
However, when you consider nuances around patients’ unique needs, medical considerations for specific diseases and trial endpoints, fully virtual trials are not appropriate for every clinical research program. IQVIA has worked with sponsors across therapeutic areas and geographies to try and test operational models with different levels of virtual components.
Hybrid trial models, where patients have some study visits on-site while others are conducted remotely, allow for a more flexible model for patients while enabling extensive physical assessments, such as imaging or biopsy, required for the protocol. The hybrid model doesn’t allow for the same expansive geographical patient reach as full virtual because patients still must visit the trial site. But, hybrid options do promise benefits for sponsors and patients, and can be a useful, low-risk way to prove that virtual elements meet all data quality and safety requirements.
In their simplest form, hybrid models can leverage a handful of virtual elements, such as secure online platforms for administrative documentation, or wearable health monitors for data collection, while maintaining a traditional on-site model for the rest of the trial. More advanced hybrid models may only require a few on-site visits for initial screenings, or for treatments that require a formal healthcare setting, then transition to a totally virtual model for the remainder of the trial.
In both cases, hybrid operational models can reduce the number of patient site visits and make data collection easier and more frequent.
The third model deploys virtual and traditional site-based arms within the same trial. This can be useful if virtual components are not accepted for certain countries or communities; or as a way to compare virtual and traditional trial models while mitigating performance risks. For example, we are currently working with a sponsor who is simultaneously running traditional and virtual arms of a trial to pilot the use of a virtual trial model without compromising study completion.
The virtual arm option can be a powerful way to demonstrate the benefits of a virtual environment, and to compare the consistency and quality of data captured in traditional and virtual settings.
Which model is right for you?
Advances in analytics and technology are allowing the promise of virtual trials to be used, but there is still uncertainty for many sponsors about when and where they offer the most benefit.
The best way to determine the right model for any clinical trial is to work with experts who understand the clinical environment for a specific disease area, and how the virtual technology can be safely and effectively deployed in these settings.
When we work with customers interested in virtual models, we begin with an assessment of the protocols, which is conducted by medical experts who score the trial based on patient needs, treatment scenarios, safety profile, trial duration, and required endpoint data.
Then we conduct an operational assessment to understand the logistics and economics of the trial, and the technical and support needs of patients and investigators. This includes a review of patients’ ability to conduct study activities at home, their access to local care facilities, and their comfort using virtual tools.
Finally, we help sponsors engage with regulators to gage their willingness to accept a virtual trial operational model, and to get their feedback on the trial design.
All of these assessments help us determine which type of virtual trial model is most appropriate. Asking the right questions early in the trial planning process and working with teams that understand the unique nature of the clinical trial environment ensures sponsors can leverage all the benefits of virtual trials without compromising quality, safety or regulatory compliance.