Theelderlyaremorelikelytohavecognitiveimpair-
ment or mild dementia, and to be living alone, in
poverty or under institutional care. They are also
vulnerable to caregiver abuse, often because of
indifference, anger or physical abuse triggered by
the patients’ behavior and difficulties derived from
their disease.
Hearing or vision problems must be expected;
bright light and large print, together with honest
and simple language, much used for eliciting the
informed consent. Research subjects, whether
elderly or not, should be able to understand the
informed consent process, feel free to refuse or to
withdraw from the study without reprisal and
understand the uncertain outcomes of the new
drug, the use of placebo and the random allocation
of treatment.
The most vulnerable elderly population is found
in nursing homes or mental institutions and
frequently comprises persons of diminished or
fluctuating mental ability. Ironically, regulations
governing research in these patients were proposed
but never voted upon. The NIH established a policy
which allowed a patient, when he/she was still in
good cognitive condition, to appoint a ‘Health Care
Agent’.
For industry, prior written agreement of a family
member with the potential subject to act as ‘guar-
dian’ is preferred but not always attainable. It is
best for the researcher him/herself to meet with
relatives, nursing staff and residents, and fully
explain to them the study purpose, benefit and
risks, as well as to the patient. Not infrequently,
any of these persons may feel protective of the
patient and undermine the research objective. It is
wise that all family members who are not involved
be sent a letter explaining the research, including a
form to be completed if they wish to prevent the
patient being involved in research.
Compliance
Compliance in the elderly in general is similar to
that of the general population. If more than six
drugs are prescribed long term, or more than
three doses per day are required, then compliance
will suffer (Gately, 1968; Blackwell, 1979). These
factors are more common in the elderly. Recom-
mendations for improving compliance in older
patients are similar to any other studies, except
for one – that the physician should set priorities
for which medications are critical to patients’
health in a polypharmacy setting. The medication
regimens should be as simple as possible; the care-
giver and patient should be educated about the
name, dose and reason for all medications. Patients
should be given simple instructions on cards,
together with suggestions on how to remind
themselves – ‘tick-off cards on fridge’, ‘diary
notes’ on bathroom mirror for morning dose, or
on pantry door ‘with food’ and so on. Patients and
their caregivers should be given educational
pamphlets about their diseases. They should be
encouraged to ask questions or report possible
adverse events or strange feelings. Patients should
be asked to repeat back instructions. Lastly, there
are telephone call services which will call and
remind patients to take the medicine, or help orga-
nize cabs or transport for follow-up visits, either to
the laboratories for blood work and so on, or to the
investigator appointments.Screening and recruitment
The Chaponis (1998) survey of 19 US-based com-
panies reported also that 32% reported difficulty in
finding suitable investigative sites for geriatric
patients. In addition, those respondents involved
in phase IVoutcomes, quality-of-life and pharma-
coeconomics studies and so on, said that the lack of
‘in-company’ geriatric expertise and resources was
a barrier. Locating suitable investigative centers for
geriatric studies is only part of the solution and
works well for the smaller elderly experience stu-
dies. Nonetheless, in clinical studies undertaken
for specific diseases in aging, much larger numbers
of patients must be enrolled.
Even the large resources of the NIH can be
strained. The Systolic Hypertension in the Elderly
Person (SHEP) investigation recruited 4736
patients aged 60–96 years (average 72). The
patient screening and selection was organized
from 16 sites but took 31 months to complete,
which had initially been projected to be 24 months.15.9 ISSUES IN THE CONDUCT OF CLINICAL STUDIES IN THE ELDERLY 199