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Published on: September 20, 2019
Clinical trials in the time of a pandemic
1Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Abstract:
The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002-2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.
Insights
The world is racing to develop treatments and vaccines for the novel coronavirus (SARS-CoV-2). Unprecedented focus on clinical trials aims to mitigate severe consequences and prevent infection.
Area of Science:
- Virology
- Epidemiology
- Public Health
Background:
- A novel coronavirus, SARS-CoV-2, emerged in China in late 2019.
- The World Health Organization declared a public health emergency in January 2020 due to global spread potential.
- By March 2020, the outbreak was categorized as a pandemic with rapidly increasing global cases and deaths.
Purpose of the Study:
- To accelerate the development of treatments for SARS-CoV-2 infection.
- To expedite the creation of vaccines to prevent SARS-CoV-2 infection and reduce disease severity.
- To address the urgent need for interventions against a potentially deadly novel virus.
Main Methods:
- Initiation of clinical trials for treatments with biological plausibility.
- Commencement of early-stage vaccine development.
- Focus on understanding SARS-CoV-2's similarity to previous coronaviruses like SARS-CoV.
Main Results:
- Multiple countries identified cases of SARS-CoV-2 infection by February 2020.
- Clinical trials and vaccine development efforts were underway by early 2020.
- The pandemic designation highlighted the rapid global dissemination and severity of the disease.
Conclusions:
- The emergence of SARS-CoV-2 necessitates urgent development of medical countermeasures.
- Both treatment and prevention strategies are critical to combat the pandemic.
- Unprecedented global focus on clinical trials is key to overcoming development challenges.
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