Nearly 450 000 patients were screened (SHEP
Cooperative Research Group, 1991).
Hall (1993) reported on 15 cardiovascular stu-
dies funded by the National Heart and Lung Blood
Institute (NHLBI) over 10 years. All overran their
projected recruitment times by an average of 27%.
Overoptimistic projections are the norm, and this
norm has been called ‘Lasagna’s Law’ (Spilker and
Cramer, 1972). For pharmaceutical clinical physi-
cians and their staff, similar overruns are not
excused by management, and raise the temptation
to ‘move the target’ by closing recruitment at a
lower level. This solution compromises the statis-
tical robustness of the study; both the problem and
this solution are career busters. Better to project
realistically and plan recruitment and fallback stra-
tegies. Hall (1993) also varied the recruitment
strategies used; the most successful was commu-
nity screening. This can be done through appeals
to senior centers, churches, shopping centers and
major industrial sites (Melish, 1982). Medical
chart review is also productive if the condition
has a International Classification of Disease
(ICD) code and charts are available to the
investigators.
For large studies, mass-mailing to registered
voters, members of organized groups such as
AARP, or members of a disease association can be
helpful, with 7–12% response rate (McDermon and
Bradford, 1982). Use of media campaigns can result
in up to 11% of first protocol visits (Levenkrow and
Farquhar, 1982). These need at least 3–6 months of
planning for resources to respond to the initial wave
of inquiries. The approach can be a newspaper
article and advertisements in regional papers, TV
and radio. Appeals to community physicians for
referrals are usually disappointing, possibly caused
by the physician believing that he/she will lose a
paying patient to a research clinic.
15.10 Conclusion
The growth of the aging population, regulatory
overview and increased business opportunities
will ensure the growth of clinical research in the
elderly. Recent reports of the high level of seniors’
adverse events, many leading to deaths, both in and
outside hospitals, will force more monitoring sys-
tems for medications. Soon, plastic medicine card
chips with imprinted medication recorded by the
pharmacist will be required by third-party insurers.
This would ensure that all current concurrent med-
ications are captured.
There is a shortage of geriatric specialists, which
will take time to be corrected if the 600 drugs under
development are to be adequately researched. The
rapid growth of sheltered self-care communal
housing for active seniors, which guarantee health-
care up to terminal status, illustrates that seniors
wish to stay out of nursing homes. Their expecta-
tion of the pharmaceutical industry is that it should
provide them with medications which allow for an
active old age. The industry has heard.References
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