There should be a legal requirement that all information provided to healthy volunteers in clinical trials is user-tested before study protocols are approved, argue two founding directors of a UK-based consultancy that designs, edits and user-tests patient information for the pharmaceutical industry.
The call was based on research commissioned by the University of Leeds from LUTO (Leeds University Testing Organisation) Research Ltd, which examined responses to the information given to healthy volunteers in the disastrous first-in-human trial of TeGenero’s monoclonal antibody TGN1412 at Northwick Park Hospital, London in March 2006.
The research showed, LUTO reported, that members of the public took up to an hour to find all of the answers to questions about key elements of the volunteer information provided in the TGN1412 trial. With six of the 21 questions, at least 20% of participants did not understand the key facts at all, LUTO said, noting that in the wake of the Northwick Park incident volunteers told the media they were allowed only about 10 minutes to review their consent forms and the drug information sheet before starting the trial.
The results were presented at last week’s Drug Information Association meeting in Ljubliana by Dr Peter Knapp, senior lecturer at the University of Leeds and one of the founding directors of LUTO, which is a spin-out from the university. The research participants were aged 18 to 40 years, to match the volunteers in the Northwick Park trial run by US-based contract research organisation TeGenero, with a range of jobs and educational backgrounds.
The testing process was the same as is used for patient information leaflets. When the research team used the participants’ responses to redesign the information sheet from the Northwick Park trial, the time taken to answer the 21 questions fell by nearly 50%, while nearly all of the key facts were found and understood by 100% of the participants, LUTO pointed out.
As it noted, user testing is a requirement for patient information leaflets (PILs) under European Union legislation, to ensure the PILs supplied with licensed medicines are clearly written and can be understood by the target audience. “Common sense dictates” that the same standards should apply to information about unlicensed medicines in clinical trials, where there is more risk to volunteers, commented Dr Theo Raynor, Professor of Pharmacy Practice at Leeds University and another founding director of LUTO.
“In the meantime”, Raynor added, “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 did to ensure a thorough and consistent approach to user-testing licensed medicines.”
