دانلود مقاله یافته های آماری در توسعه کلنیکی واکسن بیماری همه گیر
چکیده
مقدمه
مشاهدات در مورد آزمایش اثربخشی واکسن
مشاهدات در مورد ایمنی واکسن
بحث
منابع
Abstract
Introduction
Observations on Vaccine Efficacy Testing
Observations on Vaccine Safety
Discussion
References
چکیده
توسعه بالینی واکسن سنتی کاری است که شامل مطالعات دقیق و متعدد در جمعیت های متعدد در معرض خطر عفونت و بیماری در طی چندین سال است. توسعه واکسن SARS-CoV-2 و COVID-19 این مسیر توسعه سنتی را دنبال می‌کند و برنامه‌های بالینی فاز I-II-III تسریع‌شده در حال اعمال است. این اولین بار نیست که واکسن‌هایی برای مقابله با بحران بهداشت عمومی تولید و آزمایش می‌شوند. مفاهیم آماری منتخب مربوط به کارایی و ایمنی واکسن، مربوط به طراحی و اجرای چنین برنامه‌های توسعه بالینی، مورد بحث قرار خواهد گرفت.
توجه! این متن ترجمه ماشینی بوده و توسط مترجمین ای ترجمه، ترجمه نشده است.
Abstract
Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, and accelerated Phase I-II-III clinical programs are being applied. This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis. Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such clinical development programs, will be discussed.
Introduction
Pandemic disease is a recorded reality of human history (Armstrong 2016; McNeill 1976). In the past, generational development of immune system memory and resistance (sometimes called “herd” immunity) was the path to disease eradication. Modern medicine, however, has resulted in treatments and in vaccines which have ameliorated (e.g., polio, chicken-pox, and influenza) or eliminated (e.g., small-pox) disease vectors and the resulting disease.
Ten years and approximately a billion dollars is the usual time and expenditure to develop a safe and effective and well manufactured product in the modern, Western regulatory environment (DiMasi 2001; DiMasi, Hansen, and Grabowski 2003). Most of this time is spent performing clinical trials. Even if scientifically successful (subject to local regulatory and governmental requirements), only certain selected products may subsequently be recommended for use in large segments of local human populations.
Results and analyses
The global COVID-19 pandemic caused by a novel coronavirus SARS-CoV-2 may be ameliorated or stopped by safe and effective vaccines. Unprecedented collaborations have arisen among academia, industry, and governments around the globe, and much progress have been made to accelerate vaccine research and development. Multiple vaccine candidates from various platforms are currently in clinical development, and several vaccines have been authorized for emergency use. In this article, we discuss three key statistical issues that are important in establishing safety and effectiveness of a COVID-19 vaccine, based on current understanding of the science and available regulatory guidance.