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Details

Autor(en) / Beteiligte
Titel
Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis
Ist Teil von
  • Contemporary clinical trials, 2021-05, Vol.104, p.106355-106355, Article 106355
Ort / Verlag
United States: Elsevier Inc
Erscheinungsjahr
2021
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
  • 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. 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. 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. 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. Trial registration: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. •Informed sites about deviations and resolved missing or inconsistent data.•Minimized future deviations, queries, and data inconsistencies.•Tailored training messages, creating a cycle of quality improvement.
Sprache
Englisch
Identifikatoren
ISSN: 1551-7144
eISSN: 1559-2030
DOI: 10.1016/j.cct.2021.106355
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8180498

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