Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis

被引：4

作者：

Bryant, Kia E. ^{[1
]}

Yuan, Yan ^{[1
]}

Engle, Melissa ^{[2
]}

Kurbatova, Ekaterina, V ^{[1
]}

Allen-Blige, Cynthia ^{[3
]}

Batra, Kumar ^{[3
]}

Brown, Nicole E. ^{[1
]}

Chiu, Kuo Wei ^{[3
]}

Davis, Howard ^{[3
]}

Elskamp, Mascha ^{[4
]}

Fagley, Melissa ^{[1
]}

Fedrick, Pamela ^{[3
]}

Hedges, Kimberley N. C. ^{[1
,3
]}

Narunsky, Kim ^{[5
]}

Nassali, Joanita ^{[6
]}

Phan, Mimi ^{[7
]}

Ha Phan ^{[8
]}

Purfield, Anne E. ^{[1
,9
]}

Ricaldi, Jessica N. ^{[1
]}

Robergeau-Hunt, Kathleen ^{[10
]}

Whitworth, William C. ^{[1
]}

Sizemore, Erin E. ^{[1
]}

机构：

[1] US Ctr Dis Control & Prevent, Atlanta, GA USA

[2] Univ Texas Hlth Sci Ctr San Antonio, Audie L Murphy Vet Affairs Med Ctr, San Antonio, TX 78229 USA

[3] Peraton, Herndon, VA USA

[4] Columbia Univ, Irving Med Ctr, New York, NY USA

[5] Univ Cape Town, Lung Inst, Cape Town, South Africa

[6] Uganda Case Western Reserve Univ Res Collaborat, Kampala, Uganda

[7] Northrop Grumman Corp, San Diego, CA USA

[8] Univ California San Francisco Res Collaborat, Vietnam Natl TB Program, Hanoi, Vietnam

[9] US Publ Hlth Serv Commissioned Corps, Rockville, MD USA

[10] Westat Corp, Rockville, MD USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2021年 / 104卷

基金：

美国国家卫生研究院;

关键词：

Tuberculosis; Clinical trial; Central monitoring; Clinical trial quality assurance; QUALITY;

D O I：

10.1016/j.cct.2021.106355

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Introduction: With the growing use of online study management systems and rapid availability of data, timely data review and quality assessments are necessary to ensure proper clinical trial implementation. In this report we describe central monitoring used to ensure protocol compliance and accurate data reporting, implemented during a large phase 3 clinical trial. Material and methods: The Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) study A5349 (S31) is an international, multi-site, randomized, open-label, controlled, non-inferiority phase 3 clinical trial comparing two 4-month regimens to a standard 6 month regimen for treatment of drug-susceptible tuberculosis (TB) among adolescents and adults with a sample size of 2500 participants. Results: Central monitoring utilized primary study data in a five-tiered approach, including (1) real-time data checks & topic-specific intervention reports, (2) missing forms reports, (3) quality assurance metrics, (4) critical data reports and (5) protocol deviation identification, aimed to detect and resolve quality challenges. Over the course of the study, 240 data checks and reports were programed across the five tiers used. Discussion: This use of primary study data to identify issues rapidly allowed the study sponsor to focus quality assurance and data cleaning activities on prioritized data, related to protocol compliance and accurate reporting of study results. Our approach enabled us to become more efficient and effective as we informed sites about deviations, resolved missing or inconsistent data, provided targeted guidance, and gained a deeper understanding of challenges experienced at clinical trial sites.

引用

页数：10

共 13 条

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