Carol A. Miller

Ethical issues concerning clinical trials

Relat ively few gerontologic nurses are directly involved with clinical drug trials, but most gerontologic nurses have opportunities to help older adults and their families make decisions about participating in such trials. For example, although people with Alzheimers disease cannot be offered any drug that will reverse the disease process, they might be given an opportunity to participate in a clinical drug trial for: • A new drug being investigated for dementia (eg, physostigmine) • A drug that has been approved for another condition and is under investigation for treatment of dementia (eg, estrogen or ibuprofen) • A drug that has been approved for one type of dementia and is being investigated for another (eg, donepezi l for vascular dementia) • A drug being evaluated for treatment of dementia-related problems (eg, melatonin for sleep disturbances) In a previous column 1 I described the drug approval process in the United States. This column will focus on phase 2 and phase 3 trials because they involve people who have been diagnosed with the condition under investigation for drug t reatment . Specifically this column will address ethical and practical issues regarding clinical trials for drugs being developed for dementia because this condition is one of the most rapidly evolving areas of drug research and is particularly relevant to gerontologic nurses. Nurses can discuss benefits and drawbacks of participating in clinical drug trials with older adults and their families and can encourage them to contact the Alzheimers Association (800-272-3900) for upto-date information on clinical drug trials for dementia. Nurses should keep in mind, however, that clinical drug trials are in progress for many conditions, and information can be obtained from such organizations as the American Cancer Society, the American Heart Association, and the Arthritis Foundation. Phase 2 trials evaluate the safety and efficacy of a drug in a control led study involving several hundred volunteers who have the targeted condition. During phase 2 studies, an investigational drug that has been found to be relatively safe in healthy volunteers is tested for the first time on people who have the condition. After phase 2 studies have been completed, volunteers are recrui ted for phase 3 studies, the purposes of which are to further evaluate the drugs safety and efficacy, including longterm results, and determine the optimal dosing regimen. These clinical trials usually last several years, involve several thousand volunteer patients, have strict criteria for part icipat ion and monitoring, and often exclude people who have medical conditions other than the targeted condition. Phase 2 and 3 studies typically are blinded, randomized, placebo-controlled, or dose comparison studies. Ideally, these studies are double blind, meaning neither the participants nor the investigators know which participants are receiving the drug being tested and which are receiving a placebo or another therapy. The assignment code is broken only after the study is completed to reveal

Update on Warfarin: special considerations for the elderly.

R ecent research indicates that we have cause for hope, as well as for caution, in using warfarin for elderly patients. Evidence for hope comes from studies concluding that warfarin is beneficial for the prevention of stroke in patients with atrial fibrillation. 1-4 Reason for caution is based on indications that the anticoagulant response of warfarin is exaggerated in older patients on the basis of age itself, independent of other factors:

Keeping an eye on the hidden effects of eye drops

Nurses are responsible for assessing both the therapeutic effectiveness and the actual or potential adverse effects of medications. As emphasized in the last column, 1 this responSibility is particularly important and challenging when nurses are working with frail elders. Even when nurses work with relatively healthy older adults, this responsibility is very challenging because of the variety of medications and medicinal products available today. Nurses often must assume the role of a detective in identifying all the medicinal products that are ingested, injected, inhaled, applied, sprayed, and used in other ways. One important but inconspicuous source of adverse medication effects is eye drops prescribed for glaucoma. Many people with glaucoma are treated with more than one type of eye drops, several of which differ in modes of action. Common types of glaucoma eye drops that have been used for several decades include sympathomimetics, beta-blockers, and miotics (subclassified as direct-acting and cholinesterase inhibitors). The risk of systemic adverse effects, including some deaths, from topical beta-adrenergic agents has been recognized since shortly after these drugs were introduced in the late 1970s. 2 Systemic effects of antiglaucoma