Virtual Trials – Benefits and Challenges

Virtual trials are otherwise called Siteless trials done partly or on the whole virtually. The mobile device or wearable sensors such as a phone, watch, or even glasses can be used to collect the medical data in the clinical research study. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose and treat through Telemedicine in turn leading to faster treatment and better retention. Studies show 80% of traditional trials fail to meet targets in enrolling and retaining patients due to constant delays in patient travelling 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 it done

Patient recruitment is done online and the interested volunteers are screened with online questionaries for a particular study. They provide Informed 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 eDiaries 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. The general and adverse events can be reported remotely on a real-time basis.

Benefits of Virtual trials

  1. 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 drop out rate and increases engagement as the patients can participate in the study at the comfort of the home premises.
  2. Patients living in far geographic areas and with disabilities to travel to the site can access virtual trials.
  3. Site visit costs are lower or do not exist hence a patient’s routine is not disturbed leading to higher efficiency and lower costs.
  4. 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.
  5. The personalized approach of the HCP and ease at every step of the trial enhances retention rates and eliminates drop-offs.
  6. 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

Challenges to Virtual trials

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

Many tier-1 pharma companies have opened up their investments into virtual trials. 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 the Virtual clinical trials in partnership with Science 37.

Site-less studies conducted remotely 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 this technology-driven trials that can bring faster and safer drugs to the market.

Cloudbyz is focussed 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.

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 solution comes with an open API that can integrate with any handheld device collecting medical data. The solution comes with the capability to execute Virtual trial approach starting from prescreening to the closeout stage leading to 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

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