Abstract
BackgroundOver 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].MethodologyIn 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.ResultsOverall, 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.ConclusionsQuality 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 RegistrationClinicalTrials.gov NCT00153777 and Current Controlled Trials ISRCTN95638385
Highlights
Microbicides are female initiated methods for the prevention of HIV and other sexually transmitted infections (STIs)
Discordances between the International Central Reference Laboratory (ICRL) and site laboratories were identified for HIV and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/N. gonorrhoeae (NG)) results
DNA contamination was identified as a cause of invalid C. trachomatis (CT)/NG results
Summary
Additional testing and investigation by the study sites, the international investigators and ICRL could confirm that the results of the first collected specimens were false positive reactions, and that no mixing up of specimens or clerical error had occurred. Aside from the regular environment checks, the laboratories were asked to do an extra cleaning when more than 5% false positive results were detected for either CT or NG following re-testing at the ICRL. This criterion was exceeded twice by the same site, once for the CT detection and once for the NG detection, another study site exceeded once the criteria for the CT detection.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
