For pharmaceutical companies, one of the most significant operational impacts of the COVID-19 is on clinical trials. On March 19, 2020, the U.S. Food and Drug Administration (FDA) issued guidance on the conduct of clinical trials during the COVID-19 pandemic. The spotlight of this guidance includes flexibility to implement COVID-19-related clinical protocol changes without prior or institutional review board (IRB) authorization and increased use of telemedicine platforms and virtual clinical sites.
With numerous lives affected and several countries on lockdown, the COVID-19 pandemic has turned out to be a matter of global concern. The rapid phase at which the virus is spreading has compelled the healthcare community to come out with rapid solutions to treat, diagnose, and prevent the spread of the virus.
For pharmaceutical companies, one of the most significant operational impacts of the pandemic is on clinical trials. As per a recent survey conducted by Continuum Clinical, COVID-19 will have a ‘big impact’ on one-third of U.S. clinical trial sites.
Many companies have halted their clinical trials, which, in turn, have ceased the progress of several investigational drugs. In the regions most affected by the pandemic, there are reports of problems in initiating new trials, and the recruitment of new patients into ongoing trials. Healthcare resources are being diverted to deal with COVID-19, and patient visits to hospitals are restricted to prevent the spread of the disease.
Quarantines are one of the critical challenges facing the proper conduct of clinical trials. Enrolled patients are facing difficulties in carrying out the trial visits and, hence, maintain treatment for their conditions. There may also be instances when the trial participants and study personnel are infected with the virus. Such patients would undoubtedly need to be dropped from the trial, which is going to affect the outcomes of the study adversely.
Apart from enrolment and retention challenges, another key aspect is the lack of medical facilities to carry out the trials; medical centers previously utilized by the trials may no longer be easily accessible or safe to use. Interruptions to the supply chain for the investigational product are also a matter of concern.
FDA Guidance on Conduct of Clinical Trials during COVID-19 Pandemic
On March 19, 2020, the U.S. Food and Drug Administration (FDA) issued “Guidance for Industry, Investigators, and Institutional Review Boards on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”. The FDA guidance outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. The spotlight of this guidance includes flexibility to implement COVID-19 related clinical protocol changes without prior FDA or institutional review board (IRB) authorization and increased use of telemedicine platforms and virtual clinical sites. The FDA states that protocol changes will depend on the particulars of each trial, including participant population, location, and medical products used.
FDA encourages use of telemedicine platforms and virtual tools as alternative methods for site visits mandated by the protocol
One of the key recommendations of FDA guidance includes the assessment of alternatives such as phone or virtual visits to in-person visits for communication and patient evaluation. FDA urges sponsors to use telemedicine platforms and virtual tools for site visits mandated by the protocol.
On March 20, 2020, the European Medicines Agency (EMA) released guidance on the management of clinical trials during the pandemic. The EMA also recommends the conversion of physical visits into contact by phone or telemedicine to ensure continuous medical care, identify adverse events, and maintain oversight.
What are virtual clinical trials or “site-less” clinical trials?
Virtual clinical trials or decentralized or “site-less” clinical trials are trials conducted through telemedicine and mobile/local healthcare providers, incorporating approaches that vary from the traditional clinical trial model.
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