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[e-drug] Quality assurance of drugs used in clinical trials: proposal for adapting guidelines

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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