A review on virtual clinical trials: The future

Narayanasetty, S.; Ravindra, Jallu

A clinical trial is a study designed to demonstrate the efficacy and safety of a drug, procedure, medical device, or diagnostic test. Since clinical trials involve research in humans, they must be carefully designed and must comply strictly with a set of ethical conditions. Logistical disadvantages, ethical constraints, costs and high execution times could have a negative impact on the execution of the clinical trial. Rapid innovation in health and health care technologies, interventions, and products require the proliferation of rigorous clinical trials to evaluate their efficacy and effectiveness. To meet these needs, the field has been slowly moving toward increasing adoption of virtual clinical trials. VCTs use tech devices and social engagement platforms to conduct trials from a patient’s home. These electronic processes offer new opportunities for a patient-centric approach to clinical research. So that the participant does not require travel to a clinical research site. The subject can participate from home using mobile device or a wearable gadget (maybe a phone, watch, or even glasses) is linked to the clinical research study. These wearable sensors record data such as body temperature and blood glucose levels, Spo2, Heart rate, Sleep cycle which are sent automatically to the study electronic data capture (EDC) record. The subjects are recruited through notifications instead of newspapers or doctors clinic, informed consent (Eligible participants are selected through screening followed by e-consent which is a set of Presentations followed by questionnaires to the participants), patient counseling, through to measuring clinical endpoints and adverse reactions (ADRs are reported to Adverse event reporting system). To conclude, until now VCTs have been used in Phase II-IV trials. Results from these trials have shown promising results. Besides, it has also been able to meet the goal of the pharma industry (low risk and high return) when conducting clinical trials.