Tackling the Exclusion of Older People from Clinical Trials

UNDER EMBARGO UNTIL 00H01 1 FEBRUARY 2010 EUROPEAN CHARTER LAUNCHED TO COMBAT EXCLUSION OF OLDER PEOPLE FROM CLINICAL TRIALS London UK, 28.1.2010 According to the European study PREDICT there is evidence that potentially beneficial treatments are less likely to be tested in older people. To combat this issue a Charter (Attached) for Older People in Clinical Trials will be launched at BMA House, London, on Monday 1st February 2010. Press briefing at 9:15 a.m. There is evidence of exclusion of older people from clinical trials for conditions that occur commonly in old age, such as heart failure, hypertension, Alzheimer's disease, depression and colorectal cancer. For example, 44% of patients with a first diagnosis of hypertension are aged over 70, yet the average age of patients in clinical trials for hypertension is 63.5 years. And even though more that 90% of geriatricians, GPs, nurses, ethicists, pharmacists and trialists surveyed agreed that under-representation causes difficulties for both prescribers and patients, this appears to be a common phenomenon. This issue is being tackled by a European study, coordinated by the Medical Economics and Research Centre, Sheffield, (MERCS) UK called PREDICT: increasing the PaRticipation of the ElDerly In Clinical Trials. It is important that doctors know whether treatments for clinical conditions common in older people are safe and effective. This is usually established by conducting a clinical trial in which eligible people are given different treatments or in some cases a placebo. It is problematic that new treatments are not adequately evaluated in older people as results from clinical trials on younger adults cannot readily be extrapolated to older people. This is because they do not take into account relevant issues such as changed metabolism, multiple chronic conditions and polypharmacy. This Charter has been developed as part of PREDICT (www.predicteu.org) a project supported by the EU to investigate in/ exclusion of older people from clinical trials in UK, Spain, Netherlands, Italy, Poland, Lithuania, Romania, Israel and the Czech Republic. The Charter is available in English, Spanish, Catalan, Dutch, Italian, Polish, Lithuanian, Romanian, Hebrew and Czech. Supported by the European Union, FP7 health research, grant number HEALTH-F4-2008-201917 Please see English version of Charter attached. For more information contact: Dr Gary Mills Director, Medical Economics & Research Centre, Sheffield (MERCS,UK). Mobile: 0781075417 Email: g.h.mills@sheffield.ac.uk; judithsinclaircohen@gmail.com

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