Benefits and Challenges of Virtual Clinical Trials

Virtual trials or siteless trials are defined as clinical trials/ clinical trial studies done partly or on the whole virtually. In this methodology, clinical research companies rely on mobile devices or wearable sensors such as a phone, watch, or even glasses can be used to collect medical data in the clinical research study.

On the other hand, patients are treated via telemedicine and medical devices during clinical testing. Healthcare providers can evaluate, diagnose, and treat through telemedicine in turn leading to faster treatment and better retention.

Studies show 80% of traditional clinical trials fail to meet targets in enrolling and retaining patients due to constant delays in patient traveling to the site, higher processing timelines indicating the importance of virtual clinical trials. Medical devices such as wearables or medical kits are given with instructions for the patient to follow. Devices also give alerts to adhere to medical prescriptions.

How is technology transforming patient recruitment for virtual trials?

The technological transformation of patient recruitment can be seen in the online recruitment campaigns and online screening practices of the interested volunteers with online questionaries for a particular study. They provide Informed consent/e-consent through the web and are then monitored through devices or nurses visit them in case of any emergencies.

Procedures and tests to be done are delivered as kits with instructions or samples are collected by medical staff for lab testing. Patients report outcomes in real-time using e-diaries and the data is accessible by the HCP’s and other medical staff in case of any risks occurring due to medication.

In the case of virtual trials, the study personnel can visit the patient at a convenient time at any clinical trial phase. The general and adverse events can be reported remotely on a real-time basis.

What are the benefits of virtual trials?

• According to the Tufts center of study 2015, 49% of participants drop out before completion in traditional clinical trials. The virtual trial approach reduces patient dropout rates and increases engagement as the patients can participate in the study at the comfort of the home premises.
• Ensures greater patient reach. Patients living in far geographic areas and with disabilities to travel to the site can access virtual trials.
• Site visit costs are lower or do not exist hence a patient’s routine is not disturbed leading to higher efficiency and lower costs.
• Patients do not have to remember any symptoms as they are observed round the clock. Adverse events are analyzed and treated at the earliest with real-time reporting leading to increased patient centricity.
• The personalized approach of the HCP and ease at every step of the trial enhances retention rates and eliminates drop-offs.
• Real-time data collected by the device is secured and is sharable to the medical staff at any time for analysis also remains with the patient. Digital data collected throughout the trials can be used to analyze and predict drug profile

What are the challenges of virtual trials?

• Study protocols that require large procedures like biopsies, high imaging systems capital equipment such as MRI cannot be performed as virtual trials.
• A large amount of data generated round the clock needs analysis and is increasing every moment.
• In the case of continuous monitoring, a few patients may not be comfortable using wearables or other devices all the time of the day.
• A device when taken off the patient by themselves or mishandling of gadgets, medical supplies may lead to an aberration in the results.
• Trials conducted in an unsterile environment could lead to discrepancies and ailments, as compared to the medical sites.
• Lower medical literacy and knowledge about technology, devices are a hindrance to virtual trials.

Despite the challenges faced in virtual trials, several tier-1 clinical research companies have shifted towards digitalization and set their own virtual trials.

For example, Pfizer’s first randomized virtual trial REMOTE in 2011, failed as the patients were old and did not possess enough knowledge about technology.  Sanofi conducted a virtual trial to test VERKKO a wireless glucose meter in 2015 and observed that the trial was successfully completed 30% early when compared to traditional trials. Novartis has also invested in virtual clinical trials in partnership with Science 37.

Site-less studies conducted remotely with technology aids concluded with efficiency in the management of trials based on time and cost. Early detection and identification of adverse events. The industry is in need of these technology-driven trials that can bring faster and safer drugs to the market.

Cloudbyz is focused on providing innovative solutions for life science customers. Cloudbyz CTMS solution offers to prescreen according to any specific study that can be accessed via mobile or any other device from any location across all four clinical trial phases.

eConsent delivers several benefits in clinical trials. Cloudbyz eConsent replaces the paper-based informed consent documents with interactive, multimedia-enabled, template-driven informed consent accessible on all mobile devices.

The solution offers participants the possibility to review the consent as often as they require, giving them time to understand, clarify, and reflect on their choices.

Cloudbyz’s solution comes with an open API that can integrate with any handheld device collecting medical data. The solution comes with the capability to execute a Virtual trial approach starting from prescreening to the closeout stage leading to a shorter time to market for new drugs.

References

https://www.sciencedirect.com/science/article/pii/S014929181730200X

https://www.sciencedirect.com/science/article/pii/S2451865418300358

https://www.ncbi.nlm.nih.gov/pubmed/28213342

http://www.appliedclinicaltrialsonline.com/virtual-clinical-trials-future-patient-engagement

By Mythri Raghunandan