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>
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