Drug test volunteers should be given clearer, easier-to-understand information before signing up to take part, say researchers at the University of Leeds. Their research follows the shocking outcome of the drug trial at Northwick Park hospital in March 2006 where six people were left fighting for their lives.
Volunteers on that disastrous trial - dubbed the "Elephant Man" drug trial by the media - were given just ten minutes to understand pages of complicated documents. The Leeds research team found that the information provided for the volunteers in the notorious TeGenero TGN 1412 drug trial was not easily understandable and this would have been apparent if it had been tested on members of the public beforehand.
They say written information should be designed and written for clarity so that volunteers understand key information about the study they are taking part in. User testing is required by EU law for the information leaflets inside medicine packs. Using a similar method the Leeds team tested the information provided to the men who took part in the drug trial at Northwick Park hospital.
The information sheet for the trial was eleven pages long and contained more than 5,500 words. Some volunteers who took part in the trial have claimed that they were given as little as ten minutes to read complex and difficult wording containing unfamiliar specialist terms and phrases such as, "pharmacokinetics" and "singlecentre, double-blind, randomised, placebo-controlled, single-escalating dose study".
Researchers found that members of the public took up to an hour to find all the answers to 21 questions about key facts in the information provided to the trial volunteers and on six per cent of occasions the participant could not find the key fact at all.
For six of the 21 questions, at least 20 per cent of participants did not understand the key facts. Some of these questions related to information as important as the emergency telephone number volunteers should use if they became unwell and telling their GP that they were taking part in the trial.
Dr Peter Knapp, who led the research said:"The information provided at Northwick Park clearly failed the readability test. People were not able either to find or to understand key pieces of information about what the study was about and what was going to happen to them.
"Given these results it is difficult to believe that the participants in the drug trial at Northwick Park were able to use the information sheet to give informed consent," said Dr Knapp.
The research team used the responses from members of the public to design a revised information sheet that performed much better. The time taken to answer the 21 questions fell by nearly half and almost all the key facts were found and understood by 100 per cent of participants. The revised participant information sheet would have 'passed' a readability test.
Dr Knapp will present the research findings at a major international conference in Slovenia next week.
The co-author of the University of Leeds research, Professor DK Theo Raynor, noted: "Like the drugs being tested, the only way to find out whether the written information given to people works is to test it on the sort of people who will be taking part in the trial – to find out whether ordinary people can find and understand the important pieces of information.
"The Research Ethics Committees that approve these trials should require the information sheets for clinical trials to be 'user tested' on members of the public. "Combining this with the use of good graphic design and expert re-writing, information sheets can be made readable and usable by drug trial volunteers." The drug, TGN 1421, manufactured by the German company Te Genero was tested on six men by the US Company Parexel in a private wing of Northwick Park hospital in March 2006.
The trial made international headlines when the volunteers developed acute side effects including heart, liver and kidney failure, septicaemia and severely swollen features. The media coverage which followed dubbed the incident the 'Elephant Man' drug trial.