Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: Lessons learned from a microbicide phase III clinical trial
PLoS ONE, Volume 5, No. 10, Article e13592, Year 2010
Notification
URL copied to clipboard!
Description
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 aboratories 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. © 2010 Crucitti et al.
Authors & Co-Authors
Crucitti, Tania
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Fransen, Katrien
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Maharaj, Rashika
South Africa, Tygerberg
South African Medical Research Council
Tenywa, Tom
Uganda, Kampala
Makerere University
Loembé, Marguerite Massinga
Canada, Quebec
Université Laval
Canada, Quebec
Chu de Québec-université Laval
Murugavel, Kailapuri G.
India, Chennai
Yr Gaitonde Centre for Aids Research and Education
Mendonca, Kevin
India, Bengaluru
St. John's Medical College
Abdellati, Saïd
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Beelaert, Greet
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
van Damme, Lut
United States, Arlington
Conrad
United States, Durham
Fhi 360
Statistics
Citations: 12
Authors: 10
Affiliations: 9
Identifiers
Doi:
10.1371/journal.pone.0013592
e-ISSN:
19326203
Research Areas
Genetics And Genomics
Infectious Diseases
Sexual And Reproductive Health