Is your newsfeed, like ours, overflowing with information about the Coronavirus and its effe...
Is your newsfeed, like ours, overflowing with information about the Coronavirus and its effects? Almost overnight, we've had to adapt to become virtual workers - a move that will no doubt reshape many industries in lasting ways.
But what does that mean for Life Sciences and specifically drug development? Is there an opportunity to drive the use of technology and change the drug life cycle?
Site closures, travel limitations and quarantining are having an enormous impact on conducting clinical trials during the current COVID-19 pandemic. Thankfully, the F.D.A. has reacted quickly to the outbreak, releasing new guidance on conducting clinical trials during the crisis.
Their updated guidance aims to ensure the safety of all trial participants while minimising the risk to trial integrity during the COVID-19 outbreak. They have urged companies and participants to keep moving forward with studies where possible.
One of their key recommendations is to use virtual visits, phone interviews, self-administration and remote monitoring to contain the spread of the virus.
But, the idea of conducting 'site-less' or 'virtual' clinical trials isn't new.
Over the last decade, the industry has seen a significant shift in how patients are viewed, and increasingly companies are taking a more patient-centric approach to conducting clinical trials. This shift, along with rapidly developing technology, has seen the rise of the 'virtual clinical trial'.
Although they take many different forms, the premise of a virtual clinical trial is that the study is conducted remotely, rather than at a physical research centre. These studies rely heavily on technology, using anything from an app on a smartphone to wearable gadgets to measure necessary health measurements.
The first hybrid virtual trial was in 2001 when Eli Lilly tested the drug tadalafil (which treats erectile dysfunction, benign prostatic hyperplasia and pulmonary arterial hypertension) using both in-person visits to the research centre and an online questionnaire.
In 2011, 10 years later, Pfizer held the first entirely virtual clinical trial. REMOTE (Research On Electronic Monitoring of Overactive Bladder Treatment Experience) hyperactive bladder study, was a randomised IND study where patients participated using the web or their smartphone. Unfortunately, the study wasn't a success as Pfizer was never able to enroll enough patients.
There is still scepticism about virtual clinical trials, and although the technology exists to conduct recruitment, informed consent, patient counselling, and measuring adverse reactions virtually, it's not widely used.
Yet, there are undeniable advantages to virtual trials versus the traditional model (even without the current barriers caused by COVID-19).
Patient Recruitment & Engagement
The most obvious advantage to the virtual trial design is that it maximises patient availability and enrolment in the study. Patient recruitment is one of the most challenging and lengthy tasks in the clinical trial process, and arguably one of the most significant barriers to success in clinical research, with almost 80% of trials failing to meet initial targets.
Continuum Clinical surveyed 170 clinical trial sites in the U.S. over 12-13th March and found 39% believe patients will be less likely to enrol in new trials during the COVID-19 pandemic.
Virtual trials are a solution to this problem, not only are they far more convenient they also increase the diversity of participants, opening up trials to those with mobility issues, the elderly or patients who live in rural areas.
Another common challenge is patient engagement - as many as 40% of Phase III trial patients become disengaged and drop out, putting the study in jeopardy. Virtually conducted trials are more patient-centred, as the research is built around the patients home life, making participation as easy as possible.
Data Collection
In a standard trial data collection is limited to scheduled appointments with patients, conducted in an artificial environment. However, virtual trials offer the opportunity to collect a complete picture of a patient's situation in real-time. Wearable technology allows patients to record and gather data while they lead their normal lives; offering trialists faster, richer data, allowing for quicker decision making.
Plus, virtual databases collect and store data directly; data cleaning becomes an on-going process, and cloud-based analytics can continually extract relevant information - reducing the risk of human errors from transcription and increasing the speed of data processing.
Reduced costs
Clinical trials account for about 75% of the expenses related to the development of a new drug. Although virtual trials still require a study site for the trial staff and an upfront investment (for data collection and analysis platforms), they are significantly more cost-effective because they don't require the multiple study sites.
Virtual trials, at this stage in the industry's experimentation, remain the exception rather than prevailing practice. However, with the obvious advantages and the COVID-19 outbreak forcing more companies to consider the virtual approach, we think the use of virtual clinical trials will grow in popularity.
Do you agree? Will COVID-19 increase the long term use of virtual clinical trials?
You can read the F.D.A. press release here. And the full list of recommendations can be viewed here.
