Moving to Virtual Clinical Trials

 

In the clinical trials industry, 80% of trials do not meet enrolment timelines, leading to a loss of $8 million per day. Delayed enrolment not only impacts trial timelines, but more trials are being cancelled because of it, preventing investigators from determining the safety and efficacy of what could be promising new therapies for patients who need them the most.  This loss can be dealt through incorporation of virtual clinical trials. Unlike traditional site based clinical trials, virtual clinical trials do not require multiple study sites. Though some research space will be required for management of a virtual clinical trial, it can generally be organized from a single facility. Also, patients need not be in proximity to sites, and the data collection requirements fit more easily into their everyday routines, improving compliance and patient engagement. Greenlight insights reported that virtual industry will reach $7.2 billion by the end of 2017, and is expected to touch $74.8 billion by 2021.

Virtual clinical trial is a new method of collecting safety and efficacy data from trial participants, from scratch of the study through execution to follow-up. The participant does not have to travel to the trial site and can make use of simple mobile applications to report general information and adverse events. Body temperature and other vital signs are send directly to the electronic data capture records via wearable sensors.

What are the benefits of virtual clinical trials?

The advantages of virtual clinical trials compared to the traditional trials are mentioned below.

1. Maximizes patient availability and enrolment: The patient recruitment phase is longest in clinical trials and almost 80% of the study fails to reach the initial target.
2. Overcome of mobility issues: As the patient is not required to travel to the trial site or doctor’s office, it is convenient for elderly participants residing in remote area.
3. Keep subjects engaged with the study: Almost 40% of the phase III clinical trials subjects drop out from the study due to many factors such as inconvenience in travelling, complexity of trial design and data collection procedure. However, virtual clinical trials does not require patient to travel to clinical study sites. Also, the data collection procedure is automated which increases the patient engagement and reduces the dropout rates.
4. Better data collection: Data collection is made easy by electronic data capture records hence; the timelines can be achieved at a faster rate.
5. Benefits to research team: With notifications, scheduling and reporting functions, researchers are freed from performing tedious administrative duties.
6. Reduce risk in drug development process: Real-time data analysis and data cleaning can be carried out simultaneously. Based on the real time clinical trial data, decisions to terminate drugs development can be made faster.
7. Cost effectiveness: The reduced number of sites involved in the study leads to reduction of the cost. While trial staff will likely still be based at a single site or a reduced number of sites in multi-site trials, the operating costs will be significantly lower.

Key challenges of virtual clinical trials

1. Sometimes
   technology may fail: When everything
   relies on technology, challenge arises if it won’t operate optimally.
2. Data accuracy
   problems: As the patients will not face the
   doctor directly, doubts exist whether ideal standard treatment care is provided
   for the patient.
3. Conservative in
   approach: Corporate conservatism is another
   major challenge as it is difficult for the sponsors to move on from traditional
   method and trust the data generated from virtual clinical trials.
4. Challenges in
   device selection:  There are concerns that the device model, the position at which the
   trial participants wear it and other factors could introduce variability into
   the trial results.

Pioneers in virtual clinical trials

REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience) trial by Pfizer in 2011 was the first virtual clinical trial. Though, the trial faced many challenges, it was the first trial to use web and smartphone based patient recruitment. Also, the patients were not required to visit the study site.

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