One of these tools is the Sequential Analysis. These tools should be effective, yet efficient, for rapid testing of such treatments. It would be of paramount importance to explore some of the tools, whether new or already known, that could help accelerate the adoption of the many proposed modalities for the treatment of diseases as COVID-19. Īs more new drugs are to be discovered, traditional designs come at their limits. Costs may be so high that trials either not performed or not completed. In addition, the power to evaluate efficacy in relevant subgroups may be limited. Traditional comparative clinical trials are difficult to conduct when large sample sizes are required, as recruitment may be challenging and increase study duration. That is particularly so in the case of COVID-19. This is, even so, when the disease is rare or lethal. Ethical considerations prompt researchers to minimize the number of patients included in a trial.
Real life cases of sequential testing trial#
On the other hand, traditional trials entail the risk of still including patients at a time when enough information is already available to answer the trial question. In small samples, because of a lack of statistical power, indeterminate results are expected. Ethically we should ensure that certain statistical standards are met in the drug’s clinical trials and that the drug will not have an undue harmful adverse effect on humans.ĭefining the optimal number of patients to be included in a study is a considerable challenge in intervention research. The WHO recommended volunteers take part in trials of the effectiveness and safety of potential treatments. It is widely presumed that new medications may take until 2021 to develop. Currently, there are more than 200 ongoing trials on different drugs or vaccines. Several antiviral and other drugs in various stages of clinical trials are being tested. Research into potential treatments for COVID-19 started in January 2020. Īs there is no approved medication yet, there is an urgent need for specific treatment targeting COVID-19. įar from being perfect, patients are given empirical antibiotics, antiviral therapy (Oseltamivir, Remdesivir, Ribavirin, Sofosbuvir, Lopinavir/Ritonavir, Favipiravir ….), fluids, immunosuppressive and systemic corticosteroids, and invasive mechanical ventilation, in addition, to support for other vital organs. The relatively high morbidity and mortality launched the hunt for an effective treatment modality directed either at the virus itself or at its different complications. Local transmission of the disease has been recorded in most countries across all six WHO regions. The World Health Organization (WHO) had declared this outbreak on 30 January 2020 as a Public Health Emergency of International Concern (PHEIC) and a Pandemic on 11 March 2020. Until now, the disease had infected more than four million and claimed the lives of more than a quarter of million people. It has since spread globally resulting in one of the most challenging recorded pandemics in the history of mankind.
Real life cases of sequential testing series#
The novel coronavirus disease (COVID-19), the latest in the series of emerging coronavirus diseases, was first identified in December 2019 in the city of Wuhan. In addition to its usefulness when the results of new forms of treatment are quickly needed, other important benefit of sequential analysis includes the ability to reach a similar conclusion about the utility of a new drug without unduly exposing more patients to the side effect of the old drug, in particularly, for the treatment of a rare disease. None of the authors in published literature, as far as we know, used sequential analysis techniques to test potential drugs for COVID-19. Sequential analysis has not been frequently used in many clinical trials where it should have been used. It is of paramount importance to explore some of the available tools that could help accelerate the adoption of any or some of the many proposed modalities for the treatment of diseases. This gains particular importance when the disease is rare or lethal which is particularly so in the case of COVID-19. Defining the optimal number of patients to be included in a study is a considerable challenge in these interventional researches. There are more than 200 ongoing trials on different drugs or vaccines, but new medications may take until 2021 to develop. In spite of the relatively high morbidity and mortality, there is no approved medication yet for COVID-19.
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