Design Considerations for Vaccine Trials with a Special Focus on COVID-19 Vaccine Development
نویسندگان
چکیده
The COVID-19 pandemic has triggered explosive activities in searching for cures, including vaccines against the SARS-CoV-2 infection. As of April 30, 2020, there are at least 102 vaccine development programs worldwide, majority which preclinical phases, five phase I trial, and three I/II trial. Experts caution rushing development, not only because knowledge about is lacking (albeit rapidly accumulating), but also a complex, lengthy process with its own rules timelines. Clinical trials critically important usually starting from small-scale gradually moving to next phases (II III) after primary objectives met. This paper intended provide an overview on design considerations clinical trials, special focus development. Given current paradigm unique features our recommendations statistical perspective include: (1) novel trial (e.g., master protocol) expedite simultaneous evaluation multiple candidate or doses, (2) human challenge studies accelerate (3) adaptive strategies group sequential designs) early termination due futility, efficacy, and/or safety, (4) extensive modeling simulation characterize establish long-term efficacy based early-phase short-term follow-up data, (5) safety as one focuses throughout all (6) leveraging real-world data evidence analysis effectiveness, (7) global collaboration form joint effort more efficient use resource expertise sharing.
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ژورنال
عنوان ژورنال: Journal of data science
سال: 2021
ISSN: ['1680-743X', '1683-8602']
DOI: https://doi.org/10.6339/jds.202007_18(3).0020