Older adults are underrepresented as subjects in drug trial, and this is particularly true for older adults with chronic disease, who represent a rapidly growing population, and who tend to take a greater amount of medication. Consequently, a large proportion of medication use takes place without robust scientific evidence. A review in the Journal of Gerontology draws attention to this evidence gap, suggesting that it results from a combination of strict exclusion criteria in clinical research and a lack of fiscal incentive for the commercial sector to adequately test commonly used drugs in frail older populations. The review suggests specific solutions to this evidence gap.
Exclusion criteria for research participation tend to prevent individuals with chronic health conditions and other health risks from participating in drug trials. While this is presumably done to minimize the risk of causing harm to participants, the findings of these drug studies are used as the basis to administer the very same drugs to patients, including those who are frail. Further, the very risk factors that lead to subjects being excluded from drug trials may influence whether or not the drug works. As noted within the article, “[i]t is somewhat ironic that our success in public health and medical care has led to a large number of older frail people [as such success has enabled the bulk of the population to live longer], yet their current medical care is severely handicapped by the exclusion of the frail from most medical research.”
The author suggests that drug trials be more inclusive of individuals who can be characterized as frail, and that, for analyzing the effects of the drug, researchers quantify the degree of frailty for subjects. This way, doctors will be better informed of the potential risks and benefits of administering a particular drug to a frail patient. The article also suggests a few simple practices that can be incorporated or better emphasized in designing drug trials, such as providing better transportation options for study participants. Further, it’s also argued that drugs that are currently on the market be re-assessed for their benefit to older and frail patients. The author acknowledges that this is a bit of a high-risk, low-reward prospect for the commercial pharmaceutical industry, and suggests that, where they exist, public health services should invest in this type of research. In addition, the article states that an innovative pharmaceutical company could end up developing a new blockbuster drug by involving older and frail populations in their research.
Lindley, RI (2011). “Drug Trials for Older People” J Gerontol A Biol Sci Med Sci (2011: epub ahead of print.) http://biomedgerontology.oxfordjournals.org/content/early/2011/05/05/gerona.glr065.abstract