The importance of virtual trials for patient engagement

How virtual trials help diminish barriers to participation and make clinical research easier for patients.

When we talk about virtual trials, many pharma companies assume that it is purely a technology play. By leveraging telemedicine, connected devices, and communication and data exchange platforms, we can improve the trial experience, cut costs and reduce timelines.

While all of this is true, technology is only an enabler. The real benefit of virtual trials – and the reason sponsors increasingly look to embrace virtual trials – is that they finally build the research experience around the needs of the patient, making participation as convenient and supportive as possible.

Patient centricity has been an aspiration in clinical research for many years. Industry leaders often talk about the importance of engaging patients in study planning, capturing ‘patient reported outcomes’, and creating a clinical research environment and culture that accommodate their needs.

Virtual trials are one of the solutions to emerge from these conversations.

Happy patient, happy sponsor

Research studies, surveys, focus groups, and one-on-one conversations have consistently found that some of the biggest barriers to trial participation are time and travel. Forcing patients – many of whom are living with chronic or life-threatening conditions – to spend hours traveling to trial sites for appointments and treatments is burdensome and interferes with their overall quality of life. This reduces their willingness to participate and increases the chance that they will drop out before the trial is completed.

Virtual trials were developed to address these issues – and the technology makes it possible. By enabling primary investigators to complete some or all visits via telemedicine, and to collect patient data automatically from connected devices and communication platforms, they are able to make participation far less time-consuming and more enjoyable.

These models are equally beneficial for sponsors. By starting with the patients’ needs and designing trials from their viewpoint, sponsors can experience significant time and cost savings.

All virtual drives big benefits

Trials that are 100% virtual (all interactions are conducted remotely) tap the fullest potential of connected devices, allowing patients to participate in even a long-term trial without leaving their home and sponsors to benefit from higher patient participation and cost savings. In these models, PIs can oversee all patients across a state or region from a single site, which dramatically reduces site overhead costs and provides access to a more diverse patient population. It also dramatically lowers the logistics burden for patients, which makes recruiting easier, and reduces the risk of attrition.

Because these trials leverage remote devices to capture data, PIs also have access to more frequent, cleaner and higher quality patient data than in traditional models that require patients to manually record information and/or capture it at infrequent site appointments. These devices capture and transmit thousands of bits of information throughout the day, providing a more accurate view of the patient’s condition. Because data collection is automated, it ensures all data is captured and stored on time and in the same format. This makes it easier for PIs to identify cause-and-effect scenarios, such as glucose levels dropping mid-day, or sleep disruption following treatment dosing, and it streamlines data collection throughout the trial.

When the virtual study includes advanced data analytics tools, multiple disparate data sources can be integrated to enrich the objectives of the study and further inform understanding of the treatment experience. For example, if a COPD patient experiences excessive coughing, investigators could link external environmental data to determine whether it was related to the treatment or some external air quality issues.

All of these benefits result in more robust studies and allow investigators to more rapidly identify trends related to safety and clinical outcomes.

Hybrids – the best of both worlds

While the virtual model holds obvious appeal, sponsors don’t have to go fully virtual to realise the benefits for patients and their own bottom-line. Today, many sponsors are starting with hybrid models that include some virtual elements while other activities are conducted on site. This can be an ideal way for sponsors to test the waters of virtual trials and to demonstrate to stakeholders and regulators that data can be collected safely and effectively to meet study goals.

Hybrid models (in which some elements are onsite, and others are virtual) also deliver many time and cost benefits for patients and sponsors. Patients may only need to come to trial sites for the first few visits, or less frequently over the course of the trial, which lowers their burden and frees PIs to oversee more patients or conduct other site activities. This can be useful in recruiting reluctant PIs who aren’t certain they want to participate in clinical research. One 2017 study found that more than half of PIs never run more than one trial due to the added workload, time requirements, and reporting burden. The time savings achieved in a virtual hybrid model addresses many of these complaints, which could make continued trial participation more appealing.

As in the fully virtual model, connected devices and data capture and exchange platforms are popular elements of hybrid trials and provide added quantity and quality of data, which can speed time to first patient in, accelerate treatment insights, and reduce the risk of lost or missing information and manual reporting delays.

In some instances, we are seeing sponsors host a fully virtual arm of a trial while the rest is run in a traditional format. This can help them test whether the virtual model works, to compare virtual trial results with their traditional models, or to accommodate global trials where virtual options may not be allowed in every country.

Start early

Traditional, fully virtual and hybrid virtual trial models all deliver measurable benefits for patients and sponsors. But achieving these benefits requires careful planning, and the support of partners who understand how and when to best deploy which model to deliver the best results.

Ideally, for a virtual trial to be successful it must be customised during the planning phase to meet the unique needs of patients, PIs, sponsors and regulators. During study planning, a virtual trial partner will help sponsors engage with the patient community to identify their treatment barriers so they can choose tools and formats to accommodate their needs. They will also help them interact with regulators to ensure they will support virtual designs before the trial begins. On the technical side, a good partner should oversee deployment of all platforms, tools and devices ensuring a fully integrated seamless experience for all participants – and provide tech support if any issues arise.

Engaging stakeholders throughout this process will minimise risks, and help sponsors prove that virtual trials can be a successful model for the future of clinical research.

Josh Rose is vice president, R&D global strategy and head of virtual trial solutions at IQVIA