Trials of treating the elderly: Determining drug safety and effectiveness

Older participants are not usually recruited for clinical trials, leaving the path to proven treatments littered with uncertainty.

By Susan J. Landers, AMNews staff. Sept. 17, 2007.

It's no surprise that a huge group of baby boomers is advancing toward old age. But what may surprise physicians as they begin to see more and more elderly patients is how shaky the research base is for treatments in this age group.

Elderly people are not generally included in clinical trials that test the safety and efficacy of medications and treatments, even though they are the prime recipients of these regimens. Physicians can find themselves wrestling with the dilemma of doing the right thing for patients without solid evidence of what works.

"The bottom line is that we have very little information on older people," said Lodovico Balducci, MD, professor of medicine and oncology and program leader of the Senior Adult Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida. "The reason is partly because clinical trials are not offered to older people."

The need for information spans the diseases from cancer to diabetes and heart disease. "Cancer is the ideal model to study because it is a chronic disease, and cancer increases with age," said Dr. Balducci. "But you could apply that to any other disease."

Consider these other areas of inquiry: What is the optimal blood sugar level for people in their 80s and 90s? Is it the same as it is for those in their 40s and 50s? How about blood pressure or cholesterol?

"These are all questions that have not been properly asked," said Dr. Balducci. "And, unfortunately, people are not always interested in asking them."