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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Home  >  Analytics & Media  >  Press Releases  >  Statement from the Association of Clinical Trial Organizations regarding unreliable information in the media



Statement from the Association of Clinical Trial Organizations regarding unreliable information in the media

November 24, 2011

In the past week, several Russian media outlets have, quoting foreign (mostly Turkish) newspapers, published information stating that about 120,000 people around the world and 893 people in Turkey have died as the result of clinical trials. The Turkish publications named an article published in the British newspaper The Independent as the primary source. That article discussed clinical trials conducted in developing countries, primarily India, which allegedly proved breaches of regulations. In connection with this, the Association of Clinical Trial Organizations (ACTO) feels necessary to make the following statement.

First. The article in The Independent does not make any claim that 120,000 people have died around the world as a result of research. The verbatim quote from The Independent is “Globally, it is estimated around 120,000 trials are taking place in 178 countries. ” In other words, we’re talking about the number of trials, not a number of dead people.

Second. The original article makes no mention of 893 people died in Turkey as a result of testing. This number was taken by Turkish journalists from the map accompanying the article in The Independent, on which several countries, including Turkey, are shown and associated with some numbers. The map was printed with the note: “Victims of lax rules: clinical trials participants around the world”. The map itself was taken from the International Register of Clinical Trials at www.clinicaltrials.gov, and represents the number of trials being conducted by country, but not the number of “victims”.

This discrepancy was noted by the Turkish Ministry of Health, which immediately refuted the accusations in the Turkish media. “As of November 2011, there were 116, 223 clinical experiments in the world, and 87 percent of them were in the U.S., Canada and Australia. Out of this number only 893 of them were in Turkey, which is not even 1 percent,” said the statement from November 16, 2011.

Third. The way that the information regarding the numbers of dead among participants in clinical trials in India has been presented is confusing for readers. The Independent says that between 2007 and 2010 in India, 1,730 people died “while or after participating in such trials”. But it does not clarify what period of “after participating” was taken into account – a year, five or ten years. The authors of the article did note that these deaths could have occurred not as a result of participation in trials – for we’re talking here about patients who may have died as a consequence of their accelerated illnesses. We know that the highest death rates are recorded in cancer trials – in which the majority of patients may die during or shortly after the end of a trial. However this was pointed out almost in passing and had little effect on the general impression given to the reader – that the number of victims of clinical trials in India is exceedingly high.

Fourth. According to The Independent, 1,730 people in clinical trials in India have died over four years, in other words an average of 432.5 deaths per year. The paper also claims that there are currently more than 150,000 people involved in clinical trials in India. Correspondingly, that would mean that based on the paper’s information, there would be 2.9 deaths per thousand trial participants. Meanwhile, the overall death rate in India, according to a variety of sources, averages between 6 and 8 deaths per thousand. So if you believe The Independent’s statistics, participating in a clinical trial actually lowers the risk of death by more than half.

Due to this distorted information, ACTO requested that The Independent details its sources of information about the number of patients allegedly died in the course of clinical trials, the selection criteria for the countries chosen shown on the map (which does not show the USA or the EU, where significantly more clinical trials are conducted than in developing countries), and also the reasons why The Independent believes that patients who die while participating in clinical trials should automatically be considered “victims”. There has been no reply.

ACTO calls on all those who work in the media to adhere to the fundamental principles of journalistic ethics when working in a professional capacity – to publish and comment only on information that comes from a reliable source that they know, and also to make every effort to avoid harming anyone with incomplete or inaccurate information.

 


 
   
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