Elderly underrepresented in clinical trials despite high disease rate

Older persons are significantly underrepresented in clinical trials even though this population represents the majority of those who receive drugs and treatments for medical conditions, according to a recently released issue brief by the International Longevity Center ? USA. “People aged 65 and over are woefully underrepresented or even excluded from clinical trails, which evaluate the safety and efficacy of drugs and treatments.” Dr. Robert N. Butler, president and CEO of the ILC-USA and co-author notes in the preface. “This can result in adverse reactions, inappropriate dosages or treatments, and the misperception that older people cannot tolerate or benefit from new drugs and procedures.” From the International Longevity Center:Older persons underrepresented in clinical trials despite high occurrence of disease among their age group

NEW YORK (January 17, 2003) – Older persons are significantly underrepresented in clinical trials even though this population represents the majority of those who receive drugs and treatments for medical conditions, according to a recently released issue brief by the International Longevity Center ? USA (ILC-USA).

“People aged 65 and over are woefully underrepresented or even excluded from clinical trails, which evaluate the safety and efficacy of drugs and treatments.” Dr. Robert N. Butler, president and CEO of the ILC-USA and co-author notes in the preface. “This can result in adverse reactions, inappropriate dosages or treatments, and the misperception that older people cannot tolerate or benefit from new drugs and procedures.”

The brief states that although the NIH Revitalization Act requires women and minorities to be better represented in NIH-funded research, there are still no formal requirements or regulations to ensure that older people are represented in drug testing trials. To support its claim, the brief highlights two comprehensive studies focused on cancer and heart disease – each a leading cause of death among older persons. The cancer study, conducted in 1999, looked at the demographics of enrollment in cancer treatment trials.

The study found “only 25 percent of the enrollees were 65 and over, even though the authors note that 63 percent of all cancer patients are in this age group.” –more– Older persons underrepresented in clinical trials 2 The second study cited appeared in the Journal of the American Medical Association and looked at hundreds of clinical trials between 1966 and 2000. The study found that “between 1991 and 2000 only 9 percent of patients enrolled in the trials studying treatments for acute heart conditions were 75 and over, but almost 40 percent of people who suffer from heart attacks are in this age group.” Using the same heart disease study as evidence, the brief goes on to state, “40 percent of the trials between 1991 and 2000 explicitly excluded people over 75 from participating.”

The authors offer solutions to the drastic oversight of older persons’ participation in clinical trials. These recommendations include:
? Creating a national clinical trials and evaluation center
? Enacting legislation to create FDA and NIH regulatory standards for inclusion of older persons in clinical trials ? Urging advocacy groups for older persons to work for inclusion in clinical trials ? Initiating awareness campaigns to increase knowledge of clinical trials and how to participate ? Establishing programs to aid older participants in clinical trials
? Training physicians in the field of geriatrics to dispel myths among medical students about older people

The issue brief was co-authored by Dr. Robert N. Butler and James P. Nyberg, director of government relations, ILC-USA. The International Longevity Center-USA is a not-for-profit, nonpartisan research, policy and education organization whose mission is to help societies address the issues of population aging and longevity in positive and constructive ways and to highlight older people’s productivity and contributions to their families and to society as a whole.


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