Strengthening quality control and bioanalysis during clinical pharmacology trials

20 May 2014

When assessing the efficacy of an antimalarial drug, it can be very difficult to distinguish between actual drug resistance and inadequate drug exposure due to sub-optimal dosing recommendations or incorrect drug usage. To fully differentiate between the two it is essential that researchers accurately measure drug concentration in blood or plasma.

The WWARN Quality Assurance / Quality Control team are working closely with 48 laboratories from 26 different countries to improve the analysis of antimalarial drug regimens during clinical trials, and in turn, enhancing the overall quality of the research data captured.

The team are working with laboratories around the world in two different ways. First, they are providing in vitro, pharmacology and drug quality testing laboratories with certified drug reference standards for their studies. These reference standards ensure reliable, reproducible results that can be compared over time or location to identify trends that signal changes in malaria drug efficacy. Second, the team have designed a proficiency testing programme to help participating pharmacology laboratories assess their ability to carry out accurate drug analysis, resolve any potential problem areas and to improve the quality of their results.

During the proficiency testing, some laboratories consistently returned high quality results when using the reference standards, and in others, the proficiency testing was able to identify discrepancies and work with the laboratory to eliminate the cause(s) for the inaccurate data.

“We have been participating in the WWARN QA/QC programme (PT) for a few years now, this is an excellent scheme and provides us with high confidence in the performance of the bioanalytical methodologies employed in the laboratory as well as helping us to identify any problems we may have, says Dr Lijiang Song, Head of Clinical Pharmacology Laboratory, Mahidol-Oxford Research Unit (MORU).  He adds,“It has played a very important part in our recent successful ISO15189 accreditation (decision pending), as proficiency testing is an essential requirement in the accreditation process.

Chris Lourens, WWARN QA/QC Managerdescribes some of the programme’s achievements, “In this collaborative effort, we’ve seen tremendous progress in terms of analytical performance and the quality of the data produced by the laboratories with whom we’ve worked closely. Chris adds, “The potential of a proficiency testing programme is to improve not only the performance of an individual laboratory, but also the ability to reliably compare results from several laboratories.”   

 QA/QC laboratory distribution map                                                     

Chris Lourens is the first author of a recent paper published in Antimicrobial Agents & Chemotherapy demonstrating that the QA/QC approach developed by the WWARN network of partners has notably improved the quality of analysis of antimalarial drugs in laboratories around the world. The results suggest that the programme could be applied to improving the efficiency of laboratory analysis more widely and has the potential to be offered to research groups working on antimicrobials for other neglected tropical diseases.

Download Chris Lourens et al. Benefits of a pharmacology antimalarial reference standard and proficiency testing programme provided by the WorldWide Antimalarial Resistance Network (WWARN); Antimicrobial Agents & Chemotherapy 2014;  published online 28 April; doi: 10.1128/AAC.02362-14

Contact the team if you are interested in joining the QA/QC Proficiency Testing Programme, email: wwarn [at] wwarn [dot] org