Global pandemic COVID-19 has brought our attention to the most crucial elements of drug development and regulation. The regulators and the drug manufacturers are in a race to find a cure for this deadly virus. With such pressures and a shortened accelerated approval process, any proven antivirals and vaccines will be in the breaking news column for the next half of 2020.
Requiring new methodologies and techniques for the conduct of clinical trials due to the emergence of social distancing practices is rapidly changing the norms of the pharmaceutical industry.
With the rise of 500+ global clinical trials on COVID-19, there is also a decline in site enrollment by 14% and there are more than a few hundred trials on hold as per clinical trials.gov website.
FDA has released its guidance on clinical trials for COVID-19 along with newsletters reflecting that they are focussing on public health emergencies and naturally extending the timelines for non-COVID19 operations.
In the absence of face to face sponsor meetings, FDA is leaning towards virtual meetings. Post-COVID-19 interactions with FDA may change the way, the sponsors interact with FDA. A similar scenario of virtual interactions has been communicated by MHRA and EMEA.
In the recent virtual town hall FDA meeting, it was indicated that all inspections will be postponed and the FDA is looking into newer technologies for data transfer for virtual inspections and audits.
Sponsors have been proactive in advancing their study conduct activities with improved data collection and analysis without a human to human interface.
This changing landscape has made enrollment of the subject with virtual visits, remote monitoring, and increased video capabilities. The dependency of such technology seems to be a way forward when the study timelines are critical for the success of the clinical trial.
From a regulatory view, remote access to the patient records, along with study documents has made interesting rounds among panelists to indicate emergence of online portals for safe communication with patients.
Conclusion
Was it evident to us that we were not prepared to meet the crisis without delaying the safe approval of life-saving drugs, in spite of all scientific and technological advances?
Is this new normal of virtual conduct of clinical trials going to stay and bring a new revolution in regulations and technologies?
Please drop your thoughts below.
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