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Feature Drug Trials

Why the exclusion of older people from clinical research must stop

BMJ 2012; 344 doi: (Published 21 May 2012) Cite this as: BMJ 2012;344:e3445
  1. Geoff Watts, freelance journalist
  1. 1 London, UK
  1. geoff{at}

Age bias in clinical research leads to uncertainty about risks and benefits in new treatments for older people. Geoff Watts looks at the barriers to recruitment

Exclusion of older people from clinical research, and of under-recruitment to clinical trials, is widespread.1 This problem has stark consequences, according to an expert committee of the European Medicines Agency (EMA). “The drugs we are using in older people have not been properly evaluated.”

While the paucity of clinical trials on young children is well documented and frequently discussed, the same cannot be said of a similar shortfall at the upper end of the age spectrum. In fact older people are proportionately under-represented or even absent from most drug trials. This matters because just as children are not physiologically identical to adults, neither are very elderly people equivalent to those decades their junior.

Recognising this, and mindful that the older generation (those over 80) are the fastest growing sector of the population, the EMA recently held a workshop at its headquarters in London to consider what might be done.

One group active in this field is PREDICT (Increasing the Participation of the Elderly in Clinical Trials), a consortium funded by the European Union to study the participation of elderly people in clinical trials and propose ways of boosting recruitment. The group began by checking that the under-representation is real. It reviewed trials completed during the past 10 years in six conditions: heart failure, hypertension, coronary heart disease, depression, Alzheimer’s disease, and colorectal cancer.2

Antonoio Cherubini is a professor of geriatrics at Perugia University and a member of the EMA’s geriatric expert group. “The PREDICT study confirmed that in every condition there was a wide gap between the real clinical practice population and the patients who were included in clinical trials,” he said. …

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