Virtual Clinical trial: New Normal during Global Pandemic

Posted by KBV Research on February 4th, 2021

Concept of Virtual Clinical trials

A clinical trial is referred to as a study designed to show the efficacy and safety of a procedure, diagnostic test, medical device, or, drug. Because of the reason that clinical trials include human research, they should be carefully designed and must adhere to stringent ethical conditions.

Virtual trials, also known as decentralized trials or as “site-less, potentially bring the clinical trial experience to the home of a patient via a central, virtual coordinating site. We can enhance the efficiency to identify, monitor, and recruit patients with the help of Virtual trials enabled through advanced technical capabilities. This can also improve the experience of the patient, compliance, and retention.

Uses of Virtual Clinical Trials

1. Oncology

There are some aspects of oncology clinical trials that still require patients to physically visit sites of study or will need to be performed remotely( at a remote site or a home health visit. For instance, dosing visits that require injections, infusions,, and specific tests (such as medical imaging) still require to be carried out by a medical expert with suitable training and tools. Nonetheless, sponsors can decrease the exposure risk of cancer patients by reducing the time spent on manual visits. It is important to decrease the requirement for extra non-treatment visits by installing proven virtual trial technologies, including:

Virtual Visits: Conversation between patients and investigators through a web interface or an easy, secure app provides a simple and convenient way for patients to see their investigator from the comfort of their home which reduces the need for physical visits.

Data collection in a Digital format: Patients can directly submit clinical trial data by using tools provided to them or through their tablet, computer, or smartphone. Many quality of life, safety, and efficacies endpoints can be collected 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 superior compliance, lower drop-out rates, a high rate of recruitment, and performed faster than conventional clinical trials. The dermatological problems have a visual nature and it is relatively simple in evaluating skin diseases virtually. Furthermore, skin diseases are often not fatal and rarely need complex procedures. All these components make virtual clinical trial attractive for dermatological studies.

Also, making precise diagnoses based on images and patient symptomatology has always been a significant part of the dermatologist’s routine. Therefore, virtual clinical trials are in different ways convenient for dermatology.

Impact of Covid-19 on Virtual Clinical Trial

The global pandemic of COVID-19 has decreased trial recruitment efforts significantly. In some instances, it has even halted whole clinical trials. These are primarily due to the inability of patients to manually visit sites. Another reason could be the CRO and sponsors’ inability to visit sites to assess and monitor trial data and documents.

These factors are compelling primary stakeholders in study conduct to make complete changes across operations and businesses. This is done to take treatments and procedures from research to market. One such change is the development of the virtualization of technologies. Virtual clinical trials can change the manner in which 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 broaden the patient access to participation, increasing retention rates of patients, and eventually reducing trial timelines and costs.

Characteristics of Virtual Clinical Trials:

• Sending the treatment (drug or device) mail to the participants.
• Acquiring information about whether the treatment is beneficial or not.
• Recognize if people are right for a trial (sometimes on the basis of a medical record or X-ray, but sometimes on the basis of the self-report of a person).
• Obtaining the consent of people over the Internet.
• Identification of potential participants by gathering data based on online searches and activities of people.
• Paying the participants at different points for participation.

Challenges faced by Virtual Clinical Trials:

• Technical barrier such as Digital health technology user interface is one of the challenges faced by virtual clinical trials.
• Cultural barriers include concerns over data integrity and technology failure could also pose a serious challenge to the virtual clinical trial technology.
• Concerns regarding patient privacy like the risk of sharing confidential health data over the Internet.
• Limitation regarding operations such as low community engagement.

To Conclude:

Virtual Clinical Trial is not a different type of clinical trial but a development in clinical trials that makes trials time-saving, easier, and cost-effective for the participants. Digital health technologies help virtual clinical trials to manage to enhance retention, increasing participant diversity, and recruit at a faster rate. Some features and challenges of virtual clinical trials are also mentioned above.

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