Abstract
When conducting clinical trials under COVID-19 pandemic, protocol deviations and/or protocol violations are inevitably encountered due to possible environment change which may have an impact on the accuracy and reliability of clinical evaluation of the test treatment under investigation. Protocol deviations and/or violations include, but are not limited to, eligibility criteria, testing procedure, dose and dose regiment, treatment duration and clinical operation of the intended trial. FDA published guidance in March 2020 to assist investigators and institutional boards (IRBs) in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during the COVID-19 pandemic. The purpose of this article is to proposal methods for statistical evaluation in terms of (i) possible shift in target patient population and (ii) assessment of reproducibility of clinical studies conduct under COVID-19 pandemic environment. The proposed methods can be used to determine whether the clinical results of the intended trials are acceptable from both statistical and regulatory perspectives.
Keywords: COVID-19; Reproducibility probability; Shift in patient population.
【저자키워드】 COVID-19, Reproducibility probability, Shift in patient population., 【초록키워드】 Treatment, clinical trial, protocol, Trial, reliability, COVID-19 pandemic, clinical trials, risk, FDA, Regulatory, Accuracy, clinical evaluation, Compliance, Clinical studies, eligibility criteria, Guidance, Clinical practice, clinical study, dose, not limited, Good Clinical Practice, shift, investigators, investigator, reproducibility, patient population, deviation, statistical, trial participants, IRBs, include, can be used, determine, assist, 【제목키워드】 clinical,