SOURCE: Xtalks

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November 02, 2015 15:00 ET

Virtual Clinical Trials -- Can Remote Trials Change The Clinical Trial Landscape?

TORONTO, ON--(Marketwired - November 02, 2015) - On the Xtalks Blog -- The clinical trial process plays an essential -- but expensive -- role in demonstrating the efficacy and safety of a novel pharmaceutical compound. Unfortunately for pharmaceutical developers, analysts estimate that only 1 out of every 10 drugs that start the clinical trials process are granted FDA approval.

Considering that the average cost of developing and bringing a novel pharmaceutical agent to market comes in around $2.6 billion, and the time invested into a signal project can total up to 12 years, pharmaceutical companies -- including pharmaceutical giants, Pfizer and Sanofi -- are increasingly looking for ways to lower costs and maximize return on their investment.

Last week the Xtalks Blog covered the rising cost of both newly-approved and off-patent medications, and tackled the question of whether those costs are justified. This week we're covering a potentially viable alternative to traditional site-based clinical trials: virtual clinical trials.

Virtual clinical trials are a relatively new method of collecting safety and efficacy data from human trial participants. These trials take full advantage of the omnipresent technology and online social engagement that are a part of its participants' lives, by using electronic versions of all trial processes including recruitment, informed consent, patient counselling, and data collection.

Benefits of Virtual Clinical Trials

Virtually-conducted -- or remote -- clinical trials represent a more patient-centered approach to pharmaceutical research. The most obvious advantage of remote monitoring in a clinical trial is that this trial design maximizes patient eligibility and enrollment in the study.

Unlike site-based clinical trials which require frequent visits to a designated research facility, remote clinical trials are based from the patient's home so those with mobility issues -- such as the elderly -- or patients who live in rural areas, are also able to participate in the trial. While virtual trials still require a study site to house support staff, and investment into data collection and analysis platforms, they are significantly more cost effective because they don't require the traditional brick-and-mortar of 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 whereas traditional clinical trial models may require the use of multiple study sites to facilitate patient recruitment and data collection. The cost of managing a single study site is estimated to be between $1,500 and $2,500 per month, so any reduction in the number of operational study sites offers considerable capital savings.

The remote monitoring approach to virtual clinical trials is also ideal for maximizing stakeholder engagement. All groups who have a vested interest in the success of the trial -- including investors, physicians, government agencies, patient advocacy groups and even the patients themselves -- can play a role in study design, and optimization of the remote monitoring approach as a whole.

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