The vast majority of people who suffer from heart problems are over the age of 65. Yet many treatments for heart failure are never actually tested in the elderly and without good reason, according to a study published yesterday in the Archives of Internal Medicine.
In a international meta-analysis of 251 clinical trials investigating drugs, devices, and other treatments for heart failure, a team led by Antonio Cherubini of Italy’s University of Perugia Medical School found that almost half of the trials unfairly left out senior citizens due to an arbitrary upper age limit, physical disability or use of other medications.
“Exclusion of older people in clinical trials is still widespread,” Cherubini told Nature Medicine. “We need to change the regulations. We need to put in some sort of requirement to include older subjects in these studies.”
Cherubini acknowledges that including older participants introduces added complexities and costs, but argues that science must “evolve” to meet the needs and realities of ever-ageing populations across the developed world. According to the US Census Bureau, for example, the number of Americans over 65 is predicted to double by 2030.
The project is part of the ongoing EU-funded PaRticipation of the ElDerly In Clinical Trials (PREDICT) research consortium, which aims to promote the inclusion of elderly people in clinical studies. Looking ahead, the PREDICT team plans to develop new clinical trial protocols that accommodate older patients and at the same time, continue to raise awareness about the underrepresentation of the elderly in clinical trials.
Image: NIH