E-DRUG: Quality assurance of drugs used in clinical trials: proposal for adapting guidelines
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Dear Friends,
Over the last decades, the globalization of pharmaceutical production linked to poor regulatory oversight has created a situation of multiple qualitative standards, with increasing risks that patients (mostly in low and middle income countries) may receive sub-standard medicines. These represent a threat to both individual and public health. If such sub-standard products were used in clinical trials, in addition, also the credibility and reliability of the trials' results would be put at stake. I would like to share our recent paper appeared in the British Medical Journal, concerning the quality of medical products used in clinical trial:
Newton PN, Schellenberg D, Ashley EA, Ravinetto R, Green MD, Kuile FO, Tabernero P, White NJ, Guerin PJ.
Quality assurance of drugs used in clinical trials: proposal for adapting guidelines.
<http://www.ncbi.nlm.nih.gov/pubmed/25716700> BMJ. 2015 Feb 25;350:h602. doi: 10.1136/bmj.h602.
To ensure that the drugs and medical products used in clinical trials are of good quality, it is suggested that the CONSORT, SPIRIT, STARD, and TIDieR guidelines are adapted, and the WHO and ICH good clinical practice guidelines are updated, to include a requirement to state the quality of drugs and medical products (including diagnostic tests evaluated in trials or used for assessing inclusion criteria or endpoints). We are convinced that such a measure is very important for ensuring the quality and reliability of clinical trials results, by taking into account the challenges of the international pharmaceutical market today. The key-messages of the paper, available at
http://www.bmj.com/content/350/bmj.h602
are:
* 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
Best wishes,
Raffaella Ravinetto
Clinical Sciences Department
Institute of Tropical Medicine
Antwerpen, Belgium
Raffaella Ravinetto <rravinetto@itg.be>