There need to be more elderly people in clinical trials, says European consortium PREDICT
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. However there is evidence that new treatments are not adequately evaluated in older people, This issue is being tackled by an FP7 project, coordinated by the Medical Economics and Research Centre, Sheffield, (MERCS) UK called PREDICT increasing the PaRticipation of the ElDerly In Clinical Trials. This support action, HEALTH-F4-2008-201917, which started in February 2008, is being carried out in nine countries: UK, Spain, Netherlands, Italy, Poland, Lithuania, Romania, Israel and the Czech Republic. As part of this project a team from the Medical Research Council (MRC) UK, led by Prof Paul Dieppe, reviewed the work published in scientific journals on this topic. The aim was to find whether older people are included in clinical trials of new treatments. They also looked into the concerns that older people and their doctors have about taking part in clinical trials. Their review of published work, presented at Charles University, Prague in November 2008, suggests that potentially beneficial treatments are less likely to be tested in older people. The consequence of this is that older people may be receiving treatment that has not been tested in appropriate clinical trials. Alternatively they may not be receiving treatment because no trial has been conducted in older people. In the conditions studied, which included heart failure, Alzheimer's disease and colorectal cancer, people taking part in clinical trials were generally younger than the people typically seen by doctors in hospitals or general practice. For example, people first diagnosed with heart failure are on average in their mid seventies whereas those in trials were in their early sixties. Younger people were studied, as they are less likely to have additional health problems and be taking medicines that may interfere with the new treatment. Trial participation may be influenced by the family practitioner’s knowledge and opinions on the suitability of a clinical trial to the patient and their practice. They may be helped in forming opinions on the treatment by the involvement of a specialist in the condition under investigation. Older people who are eligible to take part in a clinical trial may be concerned about the risks involved in a new treatment and how it will affect their care. The idea of giving different treatments by random assignment and the need for signed consent may cause concern. There may be practical problems that make participating in a trial difficult such as timing of appointments, other responsibilities, transport and additional costs. People may feel that their health is too poor to take on obligations of a clinical trial. They may simply not be interested. However patients may see personal benefits from taking part in a clinical trial with possible improvements to health and care. They may wish to participate for the future benefit of others. The MRC team found studies that tried to address some of the concerns of older people. A first contact by the general practitioner helped to explain the need for a clinical trial, and a brief educational and counselling session helped explain the process of consent. Making assessments and measurements at the person’s home rather than at an outpatient clinic seemed to help people to stay in a trial once they had joined. They were surprised not to find any investigations of simple methods such as provision of transport for eligible people. Listening to views of patients and clinicians may help improve future clinical trials. And for the next stage of PREDICT health professionals and older patients, in all the participating countries, will be asked for their views. The findings will be used to draft a Charter for older people in clinical trials, due to be launched in February 2010. The Charter will be translated into a dozen languages. PREDICT hopes to facilitate the improvement of the rights of older people and the quality of health care for the ageing European population.
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Austria, Belgium, Bulgaria, Cyprus, Czechia, Germany, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, United Kingdom