Quality assurance of drugs used in clinical trials: proposal for adapting guidelines

P. N. Newton, D. Schellenberg, E. A. Ashley, R. Ravinetto, M. D. Green, F. O. t. Kuile, P. Tabernero, N. J. White, P. J. Guerin
2015 The BMJ (British Medical Journal)  
Paul Newton and colleagues propose that clinical trial guidelines should include a requirement to assess and state the quality of the drugs and other medical products used Paul N Newton professor of tropical medicine 1 , David Schellenberg professor of tropical medicine 2 , Elizabeth A Ashley infectious disease physician 3 , Raffaella Ravinetto pharmacist 4 , Michael D Green chemist 5 , Feiko O ter Kuile professor of tropical medicine 6 , Patricia Tabernero pharmacist 7 , Nicholas J White
more » ... holas J White professor of tropical medicine 8 , Philippe J Guerin professor of epidemiology and global health 7 Although substandard and falsified drugs are an enormous public health problem, particularly in the developing world, their inclusion in clinical trials has been neglected Examples from clinical research include the degradation of vitamin A capsules, poor quality sulfadoxine-pyrimethamine for a study of malaria in pregnancy in Africa, and falsified clopidogrel in the US Clinical trial guidelines (CONSORT, SPIRIT, STARD, TIDieR) and good clinical practice guidelines from WHO and ICH should include a requirement to determine and state the quality of drugs This will require increased awareness and development of infrastructure for accessible analytical capacity. The costs of analyses will need to be added to trial funding applications, and grant awarding bodies should insist on the use and documentation of quality assured drugs For personal use only: See rights and reprints
doi:10.1136/bmj.h602 pmid:25716700 fatcat:xj432vd36jauxlo3ny2ek4aqme