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Steps Could Get More Seniors Into Clinical Trials
By Joene Hendry, Reuters Health
October 1, 2008
Various strategies could encourage elderly people to participate and stay in clinical trials -- a pressing issue as the population ages -- researchers suggest.
"No one is ever too old to make a meaningful contribution to research," said Dr. Patricia S. Goode, of the University of Alabama at Birmingham.
Nevertheless, "Older participants are often specifically excluded from clinical trials, even those testing therapies that will be prescribed for older persons," Goode told Reuters Health.
She and her colleagues note in the Journal of the American College of Surgeons that trials testing different medical treatments need to recruit participants representing the people for whom the treatment is intended.
To assess potential reasons why the elderly are often excluded from research studies, the team examined the recruitment and retention of older women participating in two trials assessing surgical procedures for pelvic organ
prolapse.
The investigators developed a questionnaire that addressed factors that either facilitated or impeded trial enrollment and completion, then assessed responses from 23 physicians and 11 nurses involved in research studies.
These responses show a third of the doctors and nurses felt it is harder to recruit older study participants and more than half cited difficulties obtaining informed consent.
Other hurdles for elderly participants included caregiver involvement, having several health disorders, fatigue, and cognitive impairment.
However, when Goode and colleagues assessed actual retention rates of the 512 women enrolled in the two surgical trials -- of whom about 221 were 70 years and older -- they found older participants did not have higher drop-out rates than younger participants. The investigators also noted no age-group differences in missed follow-up visits.
"Recruitment and retention of older women for research studies can equal that of younger women if special measures are taken," Goode said.
She and her colleagues list numerous steps that can be taken to overcome barriers faced by elderly participants. These include, for example, allocating time to explain study procedures clearly, ensuring participants have transportation assistance to and from study visits, buying a lightweight amplifying headset for the clinic to help people with hearing impairment, and using large print on questionnaires.
Although these strategies haven't been tested, the researchers say they could help investigators successfully enroll and retain older subject in their clinical trials.
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