A Virtual clinical trial (VCT) is a new underutilized design of undertaking clinical research. The difference between virtual clinical trials and traditional clinical research methods is the use of technology in VCTs to perform clinical practices. VCTs generally use mobile applications to perform various clinical interventions at the comfort of the participant. These virtual trials allow sampling to be done on a vast population, reducing costs, saving time, and increasing participant diversity on patient recruitment.
Introducing virtual clinical trials in today’s world is increasingly doable and more accessible due to the extensive use of technology. Virtual reality (VR) is a technology that is being incorporated to bring a more effective form of communication during VCTs. Virtual reality allows stimuli to participants’ visual, sensory, and hearing systems. This data is able to give information on how the patient is reacting to the VCT and if at all they are undertaking the trial.
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Advantages of Virtual clinical trials
So what problems have VCTs solved in the clinical research field? VCTs have overcome the issue of patient recruitment. Conventional clinical trials tend to take time and consume money due to limitations of accessing suitable patients and keeping them committed to the end. Most patients find it difficult to visit the clinical trial site constantly. VCTs combine traditional patient recruitment with digital recruitment to save time and ensure accuracy. Patients are targeted through search engine optimization and social media, reaching worldwide eligible participants and allowing diversity.
The second advantage of VCTs is the reduced number of participant dropouts. Patients get to participate in trials through their mobile devices, eradicating mobility issues that generally lead to patient dropouts. Patients can still go to work or school and participate in tests due to the remote setup in VCTs.
Thirdly, pharma companies get to save money used in conducting clinical trials. Considerable capital is saved as the company may not require big physical sites with complicated medical equipment often seen with traditional medical centers. They do not need to reimburse the patients on travel costs and accommodation or food while on-site for the trial.
VCT’s work especially well when implemented alongside a good Laboratory Management System.
Challenges facing VCTs
- Poor data integration
Like any other practical attempt, VCRs have faced various challenges during implementation. The main problem is the lack of proper integration of collected data. Data is usually collected from multiple devices. Aggregating the information to create a compelling analysis that will qualify in the regulatory review is a challenge that faces most physicians. - Patient safety
Another challenge is the issue of patient safety, where patients lack confidence in the reaction of physicians should something go wrong. Lack of personal contact with the physicians may make it difficult for the patients to get help on time in cases of serious adverse events. - Regulatory concerns
The pharma industry is still unclear on its stand on these new technological moves in clinical research methods. This challenge has also slowed down the adoption of VCRs in the medical field. Phase 3 trial regulators have stated concerns in embracing digital endpoints due to the risks involved.
The future of virtual clinical trials
With Covid-19 having taken away the focus from making technological advancements in the medical field, the Food and Drug Administration (FDA) has developed a strategy that will allow research participants through remote data collection. This disruption in clinical research has also presented an inflection point that will lead the industry into a different angle of adopting novel technologies to improve clinical trials. Implementation of the virtual trial approach may mitigate challenges that faced patient recruitment and data collection, saving costs and reducing trial durations.
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