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International Clinical Trials

While the World Waits

Although we don’t yet know if COVID-19 will be a seasonal disease, it may recycle with other respiratory pathogens in the winter respiratory season. With that said, Phase I and II studies can be executed at any time, although off season is typically preferred so as not to confound the data with natural disease acquisition. Phase III randomised, controlled efficacy studies of vaccines aimed at preventing lab-confirmed respiratory diseases are typically conducted with the season in mind and make for an intense time for sponsors, CROs, and sites. Regardless of the phase, a potential vaccine for a pandemic respiratory virus must contend with:

An Aggressive Calendar

With a pandemic such as COVID-19, time is of the essence as the virus claims lives, overwhelms the healthcare system, upends daily life, and destabilises the global economy. These studies must be made a priority, starting with ensuring sites are ready to go when the vaccine is available. There is generally no ‘wiggle room’ in the schedule.

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About the author

Cindy Dukes has over 40 years of diversified clinical experience, including 34 years of clinical research focused in infectious diseases, vaccines, oncology, women’s health, and rare diseases. At ICON, she is the therapeutic expert for vaccines and leads ICON’s Vaccine Centre of Excellence. She also provides strategic management and oversight for studies across a number of therapeutic areas, including pivotal Phase III trials that have supported the approval of 14 vaccines as well as numerous drugs in other therapeutic areas.
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