Diagnostics · 2021
Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized ClinicalTrials (vRCTs)
Yaakov, R.A., Guler, O., Mayhugh, T., & Serena, T.E.
Diagnostics (MDPI), Vol 11, 151
In brief
This perspective argues that traditional randomized controlled trials are slow, costly and limited by recruitment and retention problems, and describes virtual randomized clinical trials (vRCTs) that use telehealth, apps, sensors and connected devices as a more patient-centric alternative. It discusses data privacy, security and ownership (including blockchain-based audit trails), regulatory compliance, and examples of early adopters inside and outside wound care. The authors note that older patients may need extra support and suggest hybrid trials that combine in-person and virtual elements.
Co-authored by SerenaGroup researchers.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.
Keywords
virtual clinical trialsdirect-to-patient studiesclinical researchstudy designpatient-centricityremote patient monitoring
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