Virtual Clinical Trials

Everything You Need to Know About Virtual Clinical Trials

Commonly abbreviated as VCTs, virtual clinical trials entail conducting research using technologies and other social engagement platforms. These technologies could be desktop and mobile applications as well as electronic monitoring devices. During the trial, the patient will not visit the hospital or facility as in the traditional setting. Everything will be done virtually using sensors and bio wearables to determine the patient’s problem or issues. Whether small or large, a patient can get the results for their condition within a few minutes.

The Benefits of Virtual Clinics Trials

• Accelerate patient recruitment: With virtual clinical trials, it is always easy to analyse and identify the right patients regardless of where they are. It takes less time to identify, recruit, and enrol patients into the clinical trials.
• Get a stronger patient engagement: Following the decentralisation of the virtual clinics, workshops can enjoy an enhanced patient engagement as the systems are flexible. The patient also enjoys a reduced burden and delivers studies directly to the patients in a digital concierge experience.
• Enhanced quality and patient safety: Virtual clinical trials eliminate the variation in data collection. Once the studies are complete, the results are near real-time and improve the detection of the safety signals. There is no alternation in the results.
• Eliminate complexity and trial timelines: Since the systems are digitally enabled, the workflows are more effective and take less time. All the people involved will also enjoy fewer errors hence resulting in shorter timelines.
• Better data collection: Technology and advanced gadgets are perfect for virtual clinical research. Patients can use smartphone apps, wearables, or bespoke e-diaries to collect data on how their bodies are reacting. Since a clinical study requires data, virtual clinical trials enhance the collection through smart devices and gadgets. Once the patient sends the data to the workshop, the data is collected and automatically sent for analysis. It is as easy as that.
• The trial is direct to the patient: During the trials, everything goes directly to the patient. It is all easier to track and monitor all the information on the internet.

Obviohealth is one of the leading providers of VCTs.

Potential issues using Virtual Clinical Trials

Despite the benefits, VCTs also have some risks.

• Privacy: While virtual clinical trials are still in their infancy stages, there has been the risk of sharing sensitive health information over the internet. A patient’s health and data are critical and sharing them over the internet exposes it to cybercrimes.
• Operational challenges: The most common operational challenge in this is the lack of community and provider engagement. More needs to be done in order to curb this.
• Technical barriers: The digital health technology user interface is among the most common technical barriers in virtual clinical trials. People need to be educated on how to use digital health technology items and platforms; navigation also affects the project’s overall productivity.
• Cultural barriers: The shift from traditional clinical trials to virtual clinical trials is all new to most people. With most people’s fears being integrity concerns, you realise that a huge percentage of people also fear that the technology may fail.

Operational Considerations for Conducting VCTs

This section discusses the considerations needed for ongoing trials.

• You must ensure that all the trial participants are safe.
• All the sponsors and clinical investigators in the virtual clinical trials must determine the participant’s safety.
• Sponsors must evaluate whether the alternative methods for safety assessments could be implemented when workable and sufficient to assure the participant’s safety.
• Enforce additional safety monitoring for the trial participants who have no access to the investigational products.
• Ensure that you put in place new processes or modify the existing processes in line with the local situation.
• Enforce changes in the protocol as required.
• It is crucial to understand that virtual clinical trials are not a ‘one-size-fits-all’ model. Soon, digital health technologies will be accepted in various settings, especially those with telemedicine capabilities. While the technology still has some downsides, that is expected to change in the coming years. The long term results for virtual clinical trials will be impressive, beneficial to all people, and beautiful. The clinical trials will streamline drug development and offer new opportunities for a contemporary and more patient-focused or oriented clinical trial.

Covid 19 has highlighted the value of virtual clinical trials and many businesses are now looking to utilise VCTs post Covid 19. Virtual Trials are also incredibly useful for businesses, especially those already utilising LIMS tools.