Principles and Practice of Pharmaceutical Medicine

contract negotiation, accounting and patient
recruitment services.
With more than one-third of US-based clinical
trials taking place inpart-time sites, they are a
popular option. They are generally defined as
trial locations in which the investigator(s) conducts
a limited amount of clinical trials annually, usually
less than four or five. They offer community-based,
actual use settings, a feature that sponsors find
attractive (Zisson, 2002), and can be profitable
because they tend to require less infrastructure
than their dedicated site counterparts.
Investigators may opt for part-time site status
when they have commitments such as private prac-
tice and academic appointments that restrict their
available time for clinical research. Also, they may
simply prefer to conduct just a few studies each
year to supplement income or to indulge a research
interest.
There is a hot market forphase Isites. Because
pharmaceutical sponsors seek to limit costs and
risk by weeding out weak drug candidates earlier,
they are increasing their investments in phase I
studies. Data suggest that phase I spending is rising
more rapidly than other sectors of the clinical
development market (Korieth, 2004).

Phase I is a collection of small safety studies

using approximately 20–100 subjects to research

the drug’s pharmacokinetics and pharmacolo-

gical effects. Substantial investment in staff and

equipment is required to conduct these studies

as the phase I site often houses inpatients, and

therefore, operates 24 h a day. With the excep-

tion of some trials for cancer and other serious

illnesses such as HIV, the studies use healthy

volunteers.

Phase I sites are found in many countries but

have been prevalent in Europe, particularly the

United Kingdom. Prior to the implementation of

the European Directive on Clinical Trials on May

1, 2004, an investigational new drug application

(IND) for studies on healthy volunteers was not

required in Europe, as it was and continues to be in

the United States. Europe’s then more lenient reg-

ulatory environment attracted business (Neuer,

2000), but with the advent of the European Direc-

tive, regulatory approval by ethics committee is

now required to begin phase I testing.

11.2 Basic infrastructure

Clinical trials cannot take place without an in-

frastructure designed to support the research func-

tion. With research studies becoming more

complex and entailing more procedures per subject

(Figure 11.3), it is critical that the staff at the

investigative site have an appreciation of what

it takes to perform good-quality clinical research

in a timely, ethical and fiscally responsible manner.

The basic infrastructure, particularly for dedi-

cated sites, includes (Miskin and Neuer, 2002)

clinical investigator

study coordinator

Director of clinical operations

quality assurance

writing of standard operating procedures (SOPs)

regulatory affairs

-^ Academic medical center
-^ Dedicated clinical trial site

• Part-time site
  -^ Phase I site

Figure 11.1 Clinical trial venues

Dedicated

sites

(22%)

Part-time

sites

(37%)

AMCs

(35%)

SMOs

(6%)

Figure 11.2 Clinical studies are conducted at various
venues

128 CH11 SITE MANAGEMENT