nurses and quality control personnel. SMOs might
also recruit patients on behalf of their doctors,
either from databases built up over the years, or
by press and radio/TV advertising, and even by
direct telemarketing. Nonphysician staff do initial
screening of potential subjects on the telephone
and in face-to-face interviews. Most SMOs exist
in conventional treatment centers; others treat only
patients who are enrolled into clinical studies, and
have no other role than to run clinical trials, rather
in the same way as phase I units.
The advantages for the sponsor are several:
recruitment by sites is rapid, they are used to deal-
ing with IRBs, monitoring is straightforward, the
quality of data is good and the general service is
cost-effective. For the patient, there is free medical
care and medication, together with ‘compensation’
for inconvenience, which can add up to an appreci-
able sum ($500þ).
Some hospital units in Europe have recently
become more commercially minded and have set
themselves up as profit centers within their own
hospitals. As financial pressures increase, with the
increased cost of medical technology and the
unfavorable demographics of an aging population,
we would expect more hospitals to go along this
route.
This leads to one other clinical development
arena that does appear different between the
United States and Europe: clinical pharmacology.
Europe has a long tradition of high-class, highly
scientific clinical pharmacology. This has led to
the setting up of a significant number of indepen-
dent companies, which have been spun-off from,
or were formed in association with, departments
of clinical pharmacology in hospitals. Such
units routinely carry out studies involving first
administration to humans, rising dose tolerance,
pharmacodynamics and sophisticated pharmaco-
kinetics. In the United States, such studies are
more likely to be carried out in the university
hospitals themselves, with the phase I CROs, gen-
erally not associated with hospitals, carrying out
the more routine bioequivalence and bioavailabil-
ity work.
Differences in societal and medical cultures
thus impact significantly on the development of
novel drugs. The ICH process has, to a major
extent, harmonized requirements but cannot and
will not of itself influence how the data to fulfill
these requirements are generated and collected.
For the foreseeable future, the United States
will be seen as the more prescriptive, litigious
society – suspicious of the results, building
conclusions from the evidence. Europe, in so
far as it can be regarded as a unity, even
today, has yet to accept the ever-present lawyer
in all public contexts, so that to the American
observer it will continue to look laissez-
faireand superficial in its regulation of drug
development.References and resources
Kluckhohn F, Strodtbeck F. 1961.Variations in Value
Orientation. Row, Peterson: Evanston, IL.
Payer L. 1990.Medicine and Culture: Notions of Health
and Sickness. Gollancz: London.
Riphagen F. 1992. ‘Different practices and perceptions
from country to country’. InConference Proceed-
ings:How to Cope with Different Medical Cultures
in Europe, IBC, London.
Webster’s. 1984.New Riverside University Dictionary
II. Riverside Publishing Co.: Baltimore, MD/
Philadelphia, PA.REFERENCES AND RESOURCES 651