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Why Typical Drug Trials Might Not Tell The Whole Story

February 3, 2010
In the US and other countries around the world, there is great concern over the fact that older people are not well represent in drug trials—despite the fact that they take a high percentage of prescribed medications—because results from trials involving younger populations may not automatically correlate to older age groups. A European-Union funded project called PREDICT, dedicated to getting older people access to drugs which have been shown to be safe and effective for their age group, has researched the extent to which the elderly are excluded from clinical trials and to come up with solutions. Researchers surveyed the medical literature on treatments for conditions common among elderly people and found evidence that the elderly were underrepresented. For example, the average age of patients in clinical trials of treatments for high blood pressure is 63, although 44 percent of patients are over 70 when they are first diagnosed. The researchers interviewed health professionals in nine countries and conducted more than 50 focus groups with elderly people and their caregivers. They concluded that both doctors and patients felt that more elderly people should be included in trials. "If treatments are not evaluated for elderly people it is difficult for doctors to balance the risks and benefits," said Dr. Gary Mills, Director of Medical Economics and Research Centre in Sheffield, England, one of the coordinators of the project. Dr. Mills said people conducting trials may need to take practical steps to help the elderly participate, such as going to their house rather than expecting them to travel. The British Geriatrics Society spokesman Professor David Oliver said the under-representation of elderly people in clinical trials was a "serious problem." He said it was easier for drug companies to carry out testing on younger people, but this means the trial group is "not representative" of the majority of people taking medicines. He added that drugs might be more or less effective on the elderly than younger older people and might have different side effects: "Doctors try to practice evidence-based medicine, but this is not possible if there are not enough elderly people in the trials." Stephen Jackson, Professor of Clinical Gerontology from King's College in London, said the reasons why not enough elderly people are included in trails go beyond practical difficulties. "The elderly are underrepresented in clinical trials because of ageism," he said, pointing out that elderly people often have more than one condition and that makes it more complicated for those conducting trials to include them—those conducting trials think it is "too much trouble" to include older people, he said, adding this would not change without regulation.