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New research presented today shows that the information given to the volunteers of the disastrous Northwick Park “Elephant Man” trial would not have passed a ‘readability’ test. The research, presented at the international meeting of the Drug Information Association today, highlights an immediate need for all information provided to volunteers in clinical trials to be ‘User Tested’ before future trial protocols can be approved.
The University of Leeds commissioned Luto Research (Leeds University Testing Organisation) to undertake the User Testing component of the presented research, which highlighted that members of the public took up to an hour to find all of the answers to questions about key facts in the volunteer information provided – and with six of the 21 questions, at least 20 per cent of participants did not understand the key facts at all. The volunteers involved in the Elephant Man trial reported to the media, after their trial ordeal, that they were only given approximately 10 minutes to review their consent forms and the drug information sheet before entering into the clinical trial. User Testing, is a form of “readability” testing and is currently applied to patient information leaflets inside medicine packs to ensure that they are clearly written and can be understood by the target audience and it is required by EU law. However, this law does not currently extend to participant information provided to people about medicines within clinical trials, which could be licensed or unlicensed.
“In light of this new research, common sense would dictate that if there is current EU legislation around the need for User Testing information provided to patients about established medicines, the same standards should be applied for information given to patients about un-licensed, and as yet un-proven, medicines, where the volunteer is at a higher degree of risk. In the meantime I have written to Research Ethics Committees asking them if they will take steps to include the User Testing of information intended for trial volunteers before they approve any clinical trial protocols. The UK could take a lead in Europe in this initiative – in the way that the Medicines and Healthcare products Regulatory Agency (MHRA) did to ensure a thorough and consistent approach to User-Testing licensed medicines”, commented Professor DK Theo Raynor, Professor of Pharmacy Practice, University of Leeds.
Source
New research presented today shows that the information given to the volunteers of the disastrous Northwick Park “Elephant Man” trial would not have passed a ‘readability’ test. The research, presented at the international meeting of the Drug Information Association today, highlights an immediate need for all information provided to volunteers in clinical trials to be ‘User Tested’ before future trial protocols can be approved.
The University of Leeds commissioned Luto Research (Leeds University Testing Organisation) to undertake the User Testing component of the presented research, which highlighted that members of the public took up to an hour to find all of the answers to questions about key facts in the volunteer information provided – and with six of the 21 questions, at least 20 per cent of participants did not understand the key facts at all. The volunteers involved in the Elephant Man trial reported to the media, after their trial ordeal, that they were only given approximately 10 minutes to review their consent forms and the drug information sheet before entering into the clinical trial. User Testing, is a form of “readability” testing and is currently applied to patient information leaflets inside medicine packs to ensure that they are clearly written and can be understood by the target audience and it is required by EU law. However, this law does not currently extend to participant information provided to people about medicines within clinical trials, which could be licensed or unlicensed.
“In light of this new research, common sense would dictate that if there is current EU legislation around the need for User Testing information provided to patients about established medicines, the same standards should be applied for information given to patients about un-licensed, and as yet un-proven, medicines, where the volunteer is at a higher degree of risk. In the meantime I have written to Research Ethics Committees asking them if they will take steps to include the User Testing of information intended for trial volunteers before they approve any clinical trial protocols. The UK could take a lead in Europe in this initiative – in the way that the Medicines and Healthcare products Regulatory Agency (MHRA) did to ensure a thorough and consistent approach to User-Testing licensed medicines”, commented Professor DK Theo Raynor, Professor of Pharmacy Practice, University of Leeds.
Source
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