Researchers call for tighter control over medicines used in clinical trials

WWARN's Head of Drug Quality, Professor Paul Newton, and colleagues* recently published important recommendations in the British Medical Journal. The paper reviews the quality of medicines used in clinical trials, and suggests that tighter guidelines are needed to ensure that drugs are carefully monitored for overall quality, deterioration and evidence of falsified or substandard medicines entering the distribution chain.

Global health policies and treatment recommendations are frequently developed using evidence generated from clinical trial reports. For this reason alone, it is critical that the quality of medicines used for trials is of a consistently high standard. The authors of the study recommend that international governing agencies should place urgent attention on the issue of drug quality and medical supplies; together the groups proposed that the guidance for clinical trials should be updated to include tighter controls to safeguard the quality of drugs sourced and administered to patients.

International guidelines, developed by the Consolidated Standards of Reporting Trials (CONSORT) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, have made tremendous progress in supporting researchers to improve the planning, implementation and review of clinical trial approaches. However, this latest research published in the British Medical Journal highlights several examples where more detailed guidance on the sourcing and monitoring of medicines would reduce the number of errors, reassure patients and waste less money on potentially ineffective trial outcomes.

The paper highlights examples of antimalarials planned to be used in clinical research with pregnant women, where the research teams discovered that less than 90% of the antimalarial sulphadoxine -pyrimethamine was actually in the stock due to be used. The team also describe problems with the efficacy of vitamin A in a Tanzanian trial where, after some 13 months, it was found that the amount of Vitamin A supplement had deteriorated to only 32% of the stated amount, despite the medicines being stored in appropriate cool conditions.

Professor Newton and his fellow researchers* confirm that this problem also occurs in Europe and North America; to highlight the challenges they share details of an investigation into a cardiac medicine shipment worth an estimated £1 million delivered to a pharmaceutical company in the USA, for a comparative trial. The ensuing revelations confirmed that the consignment was falsified, containing only 50-80% of the drug stated in the shipment.

"Professor Philippe Guérin, Director of WWARN and co-author of the paper, suggests "In addition, global health institutes should review more closely the current medicine distribution market, where globalisation of production, together with insufficient regulatory overview, has created a situation where drugs may be of very varied qualities."

These amendments would support policy makers, pharmaceutical companies, researchers and health workers to protect patient safety, ensure consistently high quality research findings, and safeguard the value of policy and treatment recommendations developed using clinical trial results.

*research partners include the Institute of Tropical Medicine (Antwerp, Belgium), the London School of Hygiene & Tropical Medicine, the Liverpool School of Tropical Medicine, the US Centers for Disease Control, and the Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People’s Democratic Republic

Read the full research findings in the British Medical Journal, and discover more of our work on Antimalarial Drug Quality. Email us with your questions info@wwarn.org. Share this story on Facebook or Twitter @WWARN

Download the paper: Newton et al. Quality assurance of drugs used in clinical trials: proposal for adapting guidelines. British Medical Journal. February 25 2015. DOI 2015;350:h602