Virtual Clinical Trial Electronic Monitoring of Patients

What do we mean by a Virtual Clinical trial?

A clinical trial can be considered as a study intended to show the safety and efficacy of a procedure, diagnostic test, drug, or medical device. Due to the fact that clinical trials include human research, they should be meticulously designed and must adhere to strict ethical conditions.

Virtual trials, also considered as decentralized trails or as “site-less, potentially bring the clinical trial experience to the home of a patient through a central, virtual coordinating site. Virtual trials empowered through advanced technical capabilities can assist in enhancing efficiency to recognize, monitor, and recruit patients while also enhancing the experience of the patient, compliance, and retention.

Application of Virtual Clinical Trials

1.       Oncology

Some part of the oncology clinical trials will continue to need patients to manually visit study sites or will required to be done remotely( at a remote site or a home health visit). For example, dosing visits that need infusion, injections and specific tests (like medical imaging) still need to be performed by a medical professional with the appropriate training and equipment.

However, sponsors can reduce cancer patients’ exposure risk by decreasing the time spent on physical visits. It is essential to decrease the requirement for extra non-treatment visits by deploying proven virtual trial technologies, including.

Virtual Visits: Discussion between patients and investigators through a simple, safe app or web interface provides a simple and convenient way for patients to see their investigator from the comfort of their home, decreasing the need for physical visits.

Collection of data digitally: Submission of clinical trial data can be done directly by the patient using tools provided to them or through their tablet, computer, or smartphone. Many efficacies, quality of life, and safety endpoints can be gathered in this manner, significantly decreasing the time needed in the clinic ePROs (Electronic Patient-Reported Outcome Assessments), cardiac measurements, and others.

2.       Dermatology

Virtual clinical trials have a high rate of recruitment, superior compliance, lower drop-out rates, and performed faster than conventional clinical trials. The nature of dermatological problems is visual and it is relatively easy in assessing skin diseases virtually. Moreover, skin diseases are often not life-threatening and rarely need complicated examinations. All these factors make virtual clinical trial appealing for dermatological research.

Moreover, making accurate diagnoses on the basis of images and patient symptomatology has always been an integral aspect of the dermatologist’s routine. Hence, virtual clinical trials are in several ways ideal for dermatology.

Features of Virtual Clinical Trials:

• Identification of potential participants by collecting data on the basis of online searches and activities of people.
• Finding out if people are suitable for a trial (sometimes on the basis of a medical record or X-ray, but sometimes on the basis of the person’s self-report).
• Acquiring the consent of people over the Internet.
• Sending the mail consisting of treatment (drug or device) to the participants.
• Obtaining information about if the treatment is working.
• Paying the participants at several points for participation.

Impact of Covid-19 on Virtual Clinical Trial

The outbreak of the COVID-19 pandemic has in many cases lowered trial recruitment efforts. In some cases, it has stopped whole clinical trials. These are mainly due to the inability of patients to manually visit sites. Another reason could be the inability of CRO and sponsors to visit sites to observe and assess trial data and documents.

These factors are forcing main stakeholders in study conduct to make hard pivots across operations and businesses. This is done to bring treatments and procedures from research to market. One such pivot is the development of the virtualization of technologies.

 Virtual clinical trials can significantly change the way studies are performed. This is done by offering an alternative to shifting some parts of participation outside of the conventional trial site and into the home of the patient. This kind of patient-centric approach can widen the patient access to participation, increasing retention rates of patients, and eventually reducing trial timelines and costs.

Limitations of Virtual Clinical Trials:

• Concerns regarding patient privacy like the risk of sharing confidential health data over the Internet.
• Challenges related to operations such as less engagement from community.
• Digital health technology user interface is one of the errors included in technical barriers.
• Cultural barriers like the risk of technology failure and concerns over data integrity.

Summing up:

Virtual Clinical Trial is not a separate kind of clinical trial but an improvement in clinical trials that makes trials time-saving, easier, and cost-effective for the participants. With the help of digital health technologies, virtual clinical trials manage to enhance retention, increasing participant diversity, and recruit at a faster rate. There are some features and limitation of virtual clinical trials that are also mentioned above.

Virtual Clinical Trials overcome the limitations confronted by traditional clinical trials such as longer appointments during working hours.

The Global Virtual Clinical Trials Market size is expected to rise at a market growth of 6.5% CAGR during the forecast period.