Clinical trials are slow, costly, and inefficient. Different studies put the average cost of drug development at $1.3 to $2.8 billion— with clinical trials accounting for about two-thirds.
Traditional trials burden patients with financial and time-costly travel requirements. On average, 70 percent of potential participants live over two hours from the trial site. Eligibility criteria are also inherently narrow, resulting in the clinical trial population often not accurately reflecting the real-world population that needs the new therapy being developed.
These reasons, combined with the disruption of the COVID-19 pandemic, have forced an industry-wide reconsideration of how trials are run. Virtual trials have come to the fore. They are decentralized and rely on digital technologies and tools such as telemedicine, wearables, electronic consent, remote patient monitoring, eConsent, and electronic patient records (ePRO). They are sometimes referred to as decentralized trials (DCTs) or digitally enabled trials.
With the global virtual clinical trials market size estimated at USD 8.3 billion by the end of 2022 and an expected compound annual growth rate (CAGR) of 5.7% from 2022 to 2030, according to Grand View Research, virtual trials will continue to reshape the way traditional clinical trials are conducted.
Many pharmaceutical and medical device companies are now testing out virtual trials to reap its many benefits. Here are five major ones.
- Patient-centricity: Virtual trials improve patient enrolment, retention, and engagement. Traditionally, over 80% of trials globally don’t enroll on time. Studies also show that patient recruitment and retention challenges often lead to delays of between 1 to 6 months for the majority of clinical trials. Virtual trials allow patients to participate in trials from the comfort of their homes or through local healthcare providers. Participants that live in rural areas, have mobility issues or lead hectic lives greatly benefit from this. The digital technology used also helps participants integrate the trial experience more seamlessly into their lives – boosting engagement.
- Diverse patient population: Virtual trials are not bound by geographical constraints. Sponsors/investigators can recruit widely online as patients living almost anywhere can participate. Consequently, virtual trials may allow recruitment of a more diverse patient population. The FDA offers guidance to enhance diversity in clinical trials and states that by adopting a wide range of baseline characteristics may create a study population that more accurately reflects how the new therapy will perform in the real world where this diversity is reflected if it is approved.
- Real-time data: Many virtual trials use wearables, mobile devices, and home monitoring systems, and so can collect near real-time, continuous data from patients. This is unlike in traditional clinical trials, where data is collected periodically at the investigator sites.
- Financial resource efficiency: Virtual clinical trials require fewer study sites than their traditional counterparts. Typically, there is one single study site (or for global trials, one in each country) where data collation, review, and patient monitoring take place. The trial’s activities are centrally managed by a remote study coordination center. This significantly reduces personnel and real estate costs. Reimbursement for travel expenses for participants also noticeably drops.
- Timesaving: The time spent conducting trials is reduced due to shorter enrollment periods and better retention (that also reduces patient drop-out rates) Virtual clinical trials also enable faster data capture and collection. Data collection is primarily electronic and automated, relieving the burden on sites study teams.
More trial complexity means intensive data capture and continuous flows are essential, and vital strategic decisions rely on real-time data analysis and intelligence moving to a virtual and direct-to-patient approach is needed to adapt to the world of decentralized trials. Here at encapsia, we have long championed the need for more efficient and effective clinical trials and offer encapsia as the solution. Our innovative platform provides an agile, revolutionary way to support the adoption of decentralized clinical trials.
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