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Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a Microbicide Phase III Clinical Trial

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dc.contributor.author Crucitti, T.
dc.contributor.author Fransen, K.
dc.contributor.author Maharaj, R.
dc.contributor.author Tenywa, T.
dc.contributor.author Massinga Loembe, M.
dc.contributor.author Murugavel, K. G.
dc.contributor.author Mendonca, K.
dc.contributor.author Abdellati, S.
dc.contributor.author Beelaert, G.
dc.contributor.author Van Damme, L.
dc.date.accessioned 2010-11-17T10:16:51Z
dc.date.available 2010-11-17T10:16:51Z
dc.date.issued 2010
dc.identifier.issn 1932-6203
dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0013592
dc.identifier.other ITG-M1A
dc.identifier.other ITG-M2A
dc.identifier.other ITG-M8B
dc.identifier.other ITG-M9B
dc.identifier.other MICRO
dc.identifier.other U-ARLAB
dc.identifier.other U-HIVSTD
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other FTA
dc.identifier.other Electronic
dc.identifier.other Abstract
dc.identifier.other UPD27
dc.identifier.uri http://hdl.handle.net/10390/6351
dc.description.abstract BACKGROUND: Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS) [1]. METHODOLOGY: In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL), responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL. RESULTS: Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented. CONCLUSIONS: Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors provide adequate resources for implementation of such comprehensive technical assessment and monitoring systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT00153777 and Current Controlled Trials ISRCTN95638385 en
dc.language English en
dc.subject Viral diseases en
dc.subject HIV en
dc.subject AIDS en
dc.subject Sexually transmitted diseases en
dc.subject STD en
dc.subject Gonorrhea en
dc.subject Neisseria gonorrhoeae en
dc.subject Chlamydia trachomatis en
dc.subject Prevention en
dc.subject Women en
dc.subject Microbicides en
dc.subject Clinical trials en
dc.subject Data collection en
dc.subject Data processing en
dc.subject Quality assurance en
dc.subject Effectiveness en
dc.subject Reliability en
dc.subject Validation en
dc.subject Local en
dc.subject Decentralization en
dc.subject Laboratory diagnosis en
dc.subject Africa, General en
dc.subject India en
dc.subject Asia, South en
dc.subject Belgium en
dc.subject Europe, West en
dc.title Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a Microbicide Phase III Clinical Trial en
dc.type Article-E en
dc.citation.issue 10 en
dc.citation.jtitle PLoS ONE en
dc.citation.volume 5 en
dc.citation.pages e13592 en
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/21048963
dc.citation.jabbreviation PLoS ONE en


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