Michael Shipton

Across the life sciences industry, there has been much talk about the cost and value of decentralized clinical trials (DCT) and the potential return on investment (ROI) when the expedited time to commercialization is considered. When faced with an 80% delay rate due to a myriad of reasons, the industry is potentially facing more than 51,000 delayed trials globally—not including new trials beginning in upcoming months and years.

 These delays are significant due to exorbitant associated costs and detrimental implications to breakthrough medicine.

A key component of the decentralized clinical trial model—a virtual site—allows participation in a clinical trial regardless of geographical location. Study care is delivered via telemedicine investigators, home healthcare staff, self/caregiver-reported data, community providers, and connected devices. In the Science 37 virtual site model, clinical trial execution is orchestrated by a unified technology platform and standardized processes with support from remote coordinators. Sponsors can expand the geographic footprint of a traditional trial, making participation possible for the 70% of patients who currently live outside a two-hour driving distance of a traditional site.

 This delivery model allows for participant access from anywhere, improving recruitment velocity, compliance, and retention.

As virtual sites are becoming a key part of protocols, sponsors face several questions. What is the ideal mix of traditional and virtual sites? What is the model that can help accelerate timelines? Can virtual sites help avoid delays while enabling diversity in clinical trials? Science 37 has examined the ROI of different scenarios of brick-and-mortar sites deployed in combination with a virtual site. Recognizing that most studies will likely contain this combination, we explore models that pharmaceutical sponsors can evaluate to find the best mix of virtual and traditional sites to meet objectives.

Science 37 released a new ROI model quantifying the value of virtual sites in multiple scenarios, based on seven drivers of value—and for each driver, an estimate of the impact on study costs and timeline. Scenarios are evaluated based on traditional and virtual site combinations to meet objectives of time, cost and risk mitigation, and diversity/inclusion.

The model output includes the cost and time associated with scenarios that correspond with key sponsor objectives, including:

The model is optimized based on sponsor objectives for the following scenarios:

Supplemental Virtual Site (for increased diversity and decreased risk)

To illustrate specific costs and benefits associated with virtual sites, we reference the following case study—a Phase II Hypertension study with 50 sites and 250 patients. The study forecasted a 6-month start-up (time to FPI) for traditional sites, a traditional site enrollment rate of 0.5 patients per site per month, and a virtual site enrollment rate of 18 patients per month.

By leveraging the ROI model, the sponsor evaluates each scenario selecting the best fit for the specific trial:

Scenario 1 - Add a supplemental virtual site

Many sponsors add a virtual site with a low-volume patient recruitment target to the existing site model as an introduction to DCT. Given the fixed start-up costs of the virtual site, this scenario can increase the R&D budget but has a more modest impact on the recruitment timeline because of the low patient volume assigned to the virtual site. Sponsors may utilize this approach to expedite time to first patient enrolled or as a risk mitigation alternative to planning for backup sites if needed. However, as the virtual site demonstrates greater recruitment velocity and diversity, Science 37 has observed that sponsors often increase the recruitment target, offering an even greater timeline benefit.

Adding a virtual site to the study delivery model while maintaining the planned number of traditional sites increases the R&D budget for the study but also delivers a projected six-month acceleration in the timeline.The net value to the company suggests a greater than 5x return on investment compared to the traditional site model, especially when the increase in diversity/inclusivity and decrease in non-performing sites are considered. While diversity was not measured in this ROI model, Science 37 has seen a 3x more diverse patient population when executing with a virtual site, in comparison to traditional clinical trials.

In this scenario, a virtual site replaces brick-and-mortar sites.The additional cost is completely offset by a decrease in sites, resulting in savings in the R&D budget.While the timeline remains similar, Science 37 has observed an increase in diversity and inclusivity, due to the removal of geography as a barrier to enrollment.Site performance risk is also decreased through a multi-channel approach to participant recruitment and retention. While there are scenarios where a full DCT approach is not possible, a fully decentralized model is often the optimal approach in rare disease studies where it is difficult to identify sufficient patients that reside near sites, observational studies, and long-term follow-up studies.

Scenario 4 - Co-optimize timeline and budget

Looking to optimize for both budget and timeline, suggests replacing 20 sites with a virtual site and a shift of ~66% of patients recruited to the virtual site. Similar to the above scenarios, this delivery approach increases study access and decreases site performance risk but results in a 4.7-month timeline acceleration with a small decrease in the R&D budget.

In this case study, the ROI Model shows that Scenario 2 offers the shortest timeline, with a savings of six months, while Scenario 4 optimizes both time and cost savings.

The scenarios highlighted above demonstrate the cost and value impact of adding a virtual site to a traditional study. One challenge in introducing any new approach into clinical research is the lack of industry experience with delivery. As such, many sponsors will choose to “dip their toe in the water” by adding a virtual site with a limited enrollment target to the study. Consequently, while this delivery design will reduce risk, the maximum return on investment will only be realized once a virtual site is implemented at a scale that meaningfully impacts the timeline or R&D Budget.

Beyond risk reduction, bringing the study to the patient is the right thing to do. Adding a virtual site to the clinical trial model opens up the possibility for any patient, anywhere, to be enrolled in the study—regardless of geography. This is a necessity for rare diseases and underserved populations and a choice for others, such as those who: don’t have a strong relationship with a clinical trial physician/site, work during the day when the clinic is open, or provide childcare in the home.For the growing majority of clinical researchers who are committed to accommodating patient choice and optionality in study delivery, the virtual site is an important delivery component that should be planned for in the protocol design at the outset to avoid the costly and time-consuming need for a protocol amendment later, to add it into the study.

Considering the strong return on investment demonstrated in the model scenarios, the added benefit of diversity and site performance risk mitigation, with the ability to deliver on the promise of broad patient access to clinical research and participant optionality, the recommendation is that sponsors plan for a mix of traditional sites and a virtual site in the initial study design. Industry leaders who understand and believe in the broad benefits of decentralization can accelerate adoption by directing their organizations to build the virtual site option into their standard operating model.

Science 37’s ROI model is already being used by numerous sponsors globally. The White Paper 

Decentralized Clinical Trials—Is There a Positive Return on Investment on a Virtual Site?

further expands on the model and can be accessed at 

https://www.science37.com/Resources/dct-roi

ClinicalTrials.gov (n.d.). Retrieved October 19, 2022, from 

https://clinicaltrials.gov/ct2/resources/trends

Sanofi launches new virtual trials offering with science 37

. Fierce Biotech. Retrieved October 19, 2022, from 

https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37

Articles

Anticipating the need for both virtual and traditional sites during the planning process can provide high ROI for sponsors.