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

BMJ 2015; 350 doi: (Published 25 February 2015) Cite this as: BMJ 2015;350:h602
  1. Paul N Newton, professor of tropical medicine1,
  2. David Schellenberg, professor of tropical medicine2,
  3. Elizabeth A Ashley, infectious disease physician3,
  4. Raffaella Ravinetto, pharmacist4,
  5. Michael D Green, chemist5,
  6. Feiko O ter Kuile, professor of tropical medicine6,
  7. Patricia Tabernero, pharmacist7,
  8. Nicholas J White, professor of tropical medicine8,
  9. Philippe J Guerin, professor of epidemiology and global health7
  1. 1Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic
  2. 2London School of Hygiene and Tropical Medicine, London, UK
  3. 3Mahidol Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  4. 4Clinical Sciences Department, Institute of Tropical Medicine, Antwerp, Belgium
  5. 5Centers for Disease Control and Prevention, Atlanta, GA, USA
  6. 6Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK
  7. 7Worldwide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Oxford University, UK
  8. 8Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Churchill Hospital, Oxford University, UK
  1. Correspondence to: P N Newton paul{at}
  • Accepted 29 December 2014

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

Although it is increasingly clear that substandard and falsified drugs and medical products (including devices) are an enormous public health problem,1 2 particularly in the developing world, clinical trials have largely been considered immune from the problem.

Clinical trial guidelines from the World Health Organization and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) require compliance with applicable good manufacturing practices for all investigational drugs and comparators.3 4 But they have not been updated since the 1990s so they do not include adequate consideration of the current challenges of the international drug market, where globalised production and insufficient regulatory overview have resulted in variable drug quality.5 6

There are many different types of poor quality drugs that could mistakenly be included in clinical trials, including those with no, too little, or too much active pharmaceutical ingredient, those with the wrong active pharmaceutical ingredient, those with inadequate bioavailability, and those that degrade with toxic products or contaminants.1 2 6 7 We argue that clinical trial guidelines (CONSORT, SPIRIT, STARD, and TIDieR) should include statements on the checking and reporting of the quality of drugs and medical products used in clinical research. The WHO and ICH guidelines should also be updated to include such recommendations.

Scope of problem

We are aware of several examples of clinical trials that have been conducted or planned using drugs that did not contain what they were stated to contain. Idindili and colleagues conducted a double blind, randomised, two arm study comparing the safety and efficacy of low dose versus high dose vitamin A supplementation in young Tanzanian infants.8 The …

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