Siteless Clinical Trials – Should Sites Be Concerned?

Siteless Clinical Trials – Should Sites Be Concerned?

There are obvious benefits to siteless trials: cost efficiency, patient convenience, and the potential for more accurate data. But, all sites and CROs are familiar with the hazards of electronic patient reported outcomes or ePRO. Indeed, siteless clinical trials may rob sites of many of the prized “simple” trials they enjoy today. However, siteless trials are not without their own hurdles and risks.

Data security is not the nebulous hazard it once was, but compliance issues in electronic healthcare still abound. The implementation of siteless trial delivery in complex trials seems unlikely in the near future. The small and situation-specific decisions made by site coordinators each day are difficult to replicate through algorithms and AI.

Proper training for patients remains a meaningful hurdle, especially in those populations less comfortable with device-based reporting. But, this will change over time as passive sensors develop to the point where patient intervention is not required for basic vital signs–subjective reporting measures for pain being more durable. The burden on the patient remains the overwhelming concern in siteless trial delivery.

A Hybrid Approach in Transition

As with the introduction of any new technology that will likely replace conventional human approaches, a hybrid approach drives the transition to full automation. Sites should expect more telemedicine and ePRO tools entering into study designs and the introduction of passive monitoring devices for basic measurements. The growth in site capabilities for patient education will demonstrate an ability to make use of these tools during the transition period.

Science 37 seems to be leading the pack with siteless solutions, leveraging its telemedicine solution dubbed NORA (Network Oriented Research Assistant). NORA has secured partnerships with Pharma giants and earned a recent round of $35MM in funding led by PPD. These investments should signal to sites the significance Sponsors and CROs place on siteless trial delivery. It is this clear direction that should inform the strategy of sites and site networks moving forward.

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