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Consistency Evaluation
Published in Shein-Chung Chow, Innovative Statistics in Regulatory Science, 2019
A multi-center trial is a trial conducted at more than one distinct center where the data collected from these centers are intended to be analyzed as a whole. At each center an identical study protocol is used. A multicenter trial is a trial with a center or site as a natural blocking or stratified variable that provides replications of clinical results. A multicenter trial should permit an overall estimation of the treatment difference for the targeted patient population across various centers. For a multi-center trial, the FDA suggests that individual center results should also be presented. In addition, the FDA suggests that statistical tests for homogeneity across centers (i.e., for detecting possible treatment-by-center interaction) be performed (FDA, 1988). Any extreme or contradictory results among centers should be noted and discussed. If there is no treatment-by-center interaction, the data can be pooled for analysis across centers.
Pharmaceutical trials
Published in Frank McKenna, David Pickersgill, The GP’s Guide to Professional and Private Work Outside the NHS, 2018
The ethical approval of a clinical trial protocol is essential and must always be obtained before any clinical trial is begun. The ethical approval of the investigator is also important, and the industry is committed to ensuring that this happens. Obviously, if a trial is being conducted in a single centre, the local research ethics committee (LREC) is able to consider the protocol and the investigator at the same time, but in a multicentre trial, where it may be acceptable to obtain ethical approval from a single committee, such as that operated by the RCGP under the chairmanship of Sir Michael Drury, the investigator’s LREC must also be involved, exercising its duty to ensure that it agrees with the ethical approval of the protocol, and taking prime responsibility for approving the investigator. The effectiveness of LRECs across the country, however, has been very variable, although steps are currently being taken by the DoH and others to improve the position.
Clinical validation of a ctDNA-Based Assay for Multi-Cancer Detection: An Interim Report from a Vietnamese Longitudinal Prospective Cohort Study of 2795 Participants
Published in Cancer Investigation, 2023
Thi Hue Hanh Nguyen, Y-Thanh Lu, Van Hoi Le, Vinh Quang Bui, Lan Hieu Nguyen, Nhu Hiep Pham, Thanh Hai Phan, Huu Thinh Nguyen, Van Song Tran, Chi Viet Bui, Van Kha Vo, Pham Thanh Nhan Nguyen, Ha Huu Phuoc Dang, Van Dung Pham, Van Thinh Cao, Thanh Dat Nguyen, Luu Hong Dang Nguyen, Ngoc Minh Phan, Trong Hieu Nguyen, Van Thien Chi Nguyen, Thi Mong Quynh Pham, Vu Uyen Tran, Minh Phong Le, Dac Ho Vo, Thi Minh Thu Tran, Minh Nguyen Nguyen, Thi Thanh Nguyen, Ba Linh Tieu, Huu Tam Phuc Nguyen, Dinh Yen An Truong, Chi Thuy Tien Cao, Van Tung Nguyen, Thi Le Quyen Le, Thi Lan Anh Luong, Thi Kim Phuong Doan, Thi Trang Dao, Canh Duy Phan, Thanh Xuan Nguyen, Nguyen Tuong Pham, Bao Toan Nguyen, Thi Thu Thuy Pham, Huu Linh Le, Cong Thanh Truong, Thanh Xuan Jasmine, Minh Chi Le, Van Bau Phan, Quang Binh Truong, Thi Huong Ly Tran, Minh Thien Huynh, Tu Quy Tran, Si Tuan Nguyen, Vu Tran, Van Khanh Tran, Huu Nguyen Nguyen, Duy Sinh Nguyen, Thi Quynh Tho Nguyen, Thi Van Phan, Thi Thanh-Thuy Do, Dinh-Kiet Truong, Hung Sang Tang, Minh Duy Phan, Hoa Giang, Hoai Nghia Nguyen, Le Son Tran
For a multi-center trial, it is essential to ensure the consistency of sample quality across different study sites. Hence, we first investigated factors that could contribute to variations in sample quality, which was assessed by plasma cfDNA yield and sequencing library efficacy. We did not observe any noticeable impact of sample processing time, from 0 to 5 days, on cfDNA concentrations or sequencing library yields. However, variations in the hemolysis rate of collected samples across research sites, possibly due to poor blood collection techniques, significantly affect library efficacy and subsequent quality of genome-wide sequencing. This suggested that homogeneity of blood sampling techniques across different clinical sites is required for consistency of sequencing quality in large-scale, multi-center screening and that appropriate training for clinicians on how to perform venipuncture using Streck cfDNA BCT tubes is important for our future extended K-DETEK study.