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

Newton PN, Schellenberg D, Ashley EA, Ravinetto R, Green MD, Kuile FO, Tabernero P, White NJ, Guerin PJ.
Doi: 10.1136/bmj.h602.  PMID: 25716700

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.