National Center for Accreditation of Health Establishments- , Tripoli-Libya, Libya.
Community Medicine Department, Faculty of Medicine-University of Tripoli , Tripoli-Libya, Libya.
Libyan J Med. 2020 Dec;15(1):1770518. doi: 10.1080/19932820.2020.1770518.
In spite of the relatively high morbidity and mortality, there is no approved medication yet for COVID-19. There are more than 200 ongoing trials on different drugs or vaccines, but new medications may take until 2021 to develop. Defining the optimal number of patients to be included in a study is a considerable challenge in these interventional researches. Ethical considerations prompt researchers to minimize the number of patients included in a trial. This gains particular importance when the disease is rare or lethal which is particularly so in the case of COVID-19. 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. These tools should be effective, yet efficient, for rapid testing of such treatments. Sequential analysis has not been frequently used in many clinical trials where it should have been used. None of the authors in published literature, as far as we know, used sequential analysis techniques to test potential drugs for COVID-19. 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.
尽管 COVID-19 的发病率和死亡率相对较高,但目前仍没有批准用于治疗 COVID-19 的药物。目前有 200 多项关于不同药物或疫苗的临床试验正在进行,但新的药物可能要到 2021 年才能开发出来。在这些干预性研究中,确定纳入研究的最佳患者数量是一个相当大的挑战。伦理考虑促使研究人员将试验中纳入的患者人数最小化。当疾病罕见或致命时,这一点尤其重要,而 COVID-19 正是如此。探索一些现有的工具来帮助加速采用许多已提出的治疗疾病的方法中的任何一种或几种是至关重要的。这些工具应该是有效的,同时也是高效的,以便快速测试这些治疗方法。在许多本应使用序贯分析的临床试验中,该方法并未得到广泛应用。据我们所知,发表的文献中没有作者使用序贯分析技术来测试 COVID-19 的潜在药物。除了当需要快速获得新形式治疗的结果时非常有用之外,序贯分析的另一个重要好处是能够在不使更多患者遭受旧药物副作用的情况下,对新药的效用得出类似的结论,特别是在治疗罕见疾病时。