Applied Clinical Trials
The European intiative of involving elderly in clinical trials picks up the pace as challenges are addressed.
A European initiative designed to increase the participation of the elderly in clinical trials is starting to gather momentum.
The PREDICT project began in February 2008. Funded by the European Union and coordinated by the Medical Economics and Research Centre in Sheffield, UK, its members consist mainly of European geriatricians who are concerned that they are often unable to prescribe the best course of treatment due to insufficient scientific evidence from clinical trials.
Clinicians are left to extrapolate from studies of younger, healthier subjects—a practice fraught with difficulty, they warn.
At the 19th World Congress of Gerontology and Geriatrics in Paris in July, the group is organizing a symposium about older people in clinical trials. Its initial data will be presented, and discussion will focus on four key questions: What evidence is there that the elderly have been excluded? Are current trials including the elderly? What are the opinions of clinicians, other professionals, patients, and caregivers? Is a charter needed for the elderly?
"The elderly consume about 40% of total medication, but they are under-represented in clinical trials," said project manager Judith Sinclair-Cohen, BDS, MSc. "With an increasingly ageing European population, it is essential to demonstrate the efficacy and safety of drugs and treatments in older people, who have different pharmacokinetics to their younger peers."
Clinical trials must take into account the relevant issues of this population, including changed metabolism, multiple chronic conditions, and polypharmacy, she noted.
The group is also investigating the perceptions of trials among the elderly. It fears that some older people may not be "health literate," particularly in newer EU member states, and many of them may be unaware of what clinical research involves and why and how it is conducted.
PREDICT (www.predicteu.org) is planning to unveil its charter at a launch meeting to be held in London next February. It will be published in 15 different languages.
Considerable challenges are associated with conducting randomized, controlled trials successfully in the elderly, wrote Lillian L. Siu, MD, in a 2007 study from the New England Journal of Medicine (Vol. 356, No. 15, p. 1575-1576). She found that barriers related to trial design, physician, patient, and logistical and financial factors are potential deterrents to the recruitment of older subjects.
Some physicians are reluctant to enroll older people in trials for cancer, citing concerns about coexisting conditions, the toxic effects of treatment, ineligibility, poor compliance, and lack of social support, Dr. Siu stated.
"The paucity of data from primary research to validate or quell these concerns leads to a vicious cycle of care that is not evidence-based," argued Siu. "Ageism is probably the greatest impediment to the enrollment of older patients in trials for cancer therapy. Many physicians and patients have an innate bias that associates older age with inferior outcomes."
The reasons behind these exclusions are usually well intentioned, but that does not make them excusable, according to Leonard Zwelling, MD, professor of medicine and pharmacology at The University of Texas M. D. Anderson Cancer Center.
"People who are elderly...can be put in a trial and be successfully treated with chemotherapy and can benefit from it as much as young people," Zwelling told OncoLog, his institution's newsletter.
"Particularly when people get above age 60 or 70, their physiologic age is probably more important than their chronologic age. Certain people are frail enough that they shouldn't go into [a] trial even if they're 50. Other people have a performance status that is fantastic when they're 80, and denying them access to a clinical trial is a bad idea."—Philip Ward