The development of vaccines against pathogenic infections, especially if the disease has acquired the status of a pandemic, is a challenge not only for scientific-applied laboratories but also for the department of statistical research engaged in clinical trials. It is known that the standard development of a drug antidote against alien organism pathogens under a protocol may take several years, as each individual stage requires careful organizational preparation (“Coronavirus disease 2019,” 2020). In the case of statistical testing of the newly developed formula for the respiratory virus causing COVID-19, there are several obvious problems.
The proposed article describes how the procedure of clinical testing of the efficacy and safety of the drug in humans is carried out. According to “The safety” (2018), post-laboratory work consists of several phases that differ in sample size and criteria defined. Once the vaccine has been tested on animals, it goes to the first phase, where it is used on 20-100 healthy volunteers. The central questions of the study here are to discuss the performance and safety of the drug, the absence of side effects, and to find a correlation between effect and dose rate. The sample is then increased to hundreds of participants, for whom the presence of side effects is assessed, and a potential immune response is determined. In general, these data are still insufficient to bring the vaccine to market, so further scaling of the sample is necessary. In a group of tens of thousands of participants, the significance of a statistical experiment is assessed, and the most common pathophysiological threats are identified.
It should be said that in a pandemic, this pattern — which has been tested for decades — can be seriously damaged. In the long term, this means that humanity will not have sufficient guarantees of safety for much-needed medicine. Cohen (2020) has described that a number of researchers have proposed to speed up the certification process by shifting the sample: using young (18-30 years) and healthy volunteers. Such a decision is unlikely to seem justified, as it is known that the main group of vulnerability for COVID-19 is older adults. Focusing on the younger volunteer generation may lead to the fact that the drug will not be effective for adult patients.
References
Coronavirus disease 2019 testing basics. (2020). US Food & Drug Administration.
Cohen, J. (2020). Speed coronavirus vaccine testing by deliberately infecting volunteers? Not so fast, some scientists warn. AAAS.
Ensuring the safety of vaccines in the United States. (2018). CDC.