LEEDS, England, October 22 /PRNewswire/ --
- Immediate Steps are Required in the Meantime to Protect Patients
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 Ltd (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.
Luto is already firmly established as a leading provider of
readability testing services for patient information materials. In response
to the latest study findings, luto has now extended its service to include
User Testing on clinical trial patient information, so pharmaceutical
companies and clinical research organisations can ensure that the information
they provide for clinical trial volunteers can be understood.
"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.
For more information on User Testing visit: http://www.luto.co.uk
Notes to editors
Dr Peter Knapp, Senior Lecturer at the University of Leeds is presenting
a paper describing this research at the DIA Conference in Ljubliana on
Wednesday October 22nd.
An article reporting this study has been accepted for publication in the
Journal of Medical Ethics.
The thirty participants in the University of Leeds research were aged
18-40, to match the volunteers in the actual trial carried out by Parexel of
the TeGenero drug TGN1412. The participants had a range of jobs and education
backgrounds to match the sorts of people who volunteer for actual clinical
trials.
The testing process was the same as is used for medicine leaflets:
(i) Key facts are selected for testing;
(ii) A questionnaire is devised to determine, for each fact, whether the
reader can find it and express it in their own words (to demonstrate
understanding);
(iii) Ten people who are potential users of the document are given the
information to read and then the questionnaire is administered to
them individually;
(iv) The test results are used to revise the information, which is then
tested on rounds of ten people;
(v) The process is repeated until each key fact can be found by 90 per
cent participants and understood by at least 90 per cent of those who
found it.
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.
Additional information:
LUTO Research Limited is a pharmaceutical consultancy specialising in the
enhancing, editing and user testing of patient information for pharmaceutical
companies. LUTO is a spin-out company of the University of Leeds. LUTO's
business proposition is to provide a User Testing service by which the
company designs and tests Patient Information Leaflets (PILs), Trial
Participant Information Sheets, Risk Management Plans and other information
on behalf of pharmaceutical clients with the aim of ensuring that they are
appropriate for use by end user patient groups. The clinical trial
participant information sheet research was funded by the University of Leeds
but was undertaken on behalf of the university at Luto.
(http://www.luto.co.uk). Dr Knapp and Professor Raynor are founding directors
of LUTO.
LEEDS, England, October 22 /PRNewswire/ --
Luto Research Ltd