data management and increaseduse ofelectronic
data capture (EDC)
accommodation for record storage
Clinical investigator
The clinical investigator is ultimately responsible
for clinical research conducted at the site. Accord-
ing to FDA and GCP regulations (Sections 312.60
and 312.64, respectively) the investigator has
broad-based responsibilities for protecting the
rights and safety of study volunteers. This is
accomplished through activities such as obtaining
informed consent, administering study drug, main-
taining and storing medical records and reporting
adverse and serious adverse events.
Physicians report that they participate in clinical
research mostly because it is scientifically reward-
ing, but they are also attracted to the financial
rewards and the opportunities to improve patient
care (Lamberti, 2005). With clinical trials number-
ing in the tens of thousands, there is industry-wide
concern that there may be a 15% shortfall in the
number of qualified US investigators in the next
few years (Zisson, 2001). There are several factors
contributing to this dilemma.
First, the number of evaluable subjects per new
drug application (NDA) continues to rise and is
now in the range of 5300, a dramatic increase from
the 3200 needed for NDAs submitted in the mid-
1980s (Lamberti, 2005). To meet this demand,
more investigators per study need to be recruited.
Second, the percentage of US investigators par-
ticipating in clinical trials has always been low, in
the range of 5% of physicians, and this number
seems to be declining. A recent study from the
Tufts Center for the Study of Drug Development
indicates that only 3% of US board certified phy-
sicians are principal investigators (Tufts Univer-
sity, 2005).
To complicate matters further, there is a high rate
of dropout among investigators. Many conduct one
or two trials and choose to never conduct another
one, leading to a dilemma in which 50% of US
principal investigators have opted out of the clin-
ical trials business. The reasons cited are that clin-
ical research interferes too much with other
responsibilities such as private practice medicine
or academic obligations, or they lack the infra-
structure to handle today’s rigorous trials.
There is good news, however. The Tufts Center
study reveals that the number of investigators in
many regions of the world is actually rising. In
addition, there are now certification programs for
investigators, so it is possible that those who invest
in preparing for and receiving certification by
examination may be less likely to drop out. Certi-
fication programs are offered by the Drug Info-
rmation Association (DIA) and through the
Association of Clinical Research Professionals
(ACRP) affiliate, the Academy of Pharmaceutical
Physicians and Investigators (APPI). Certification
offered through DIA is the Certified Clinical
Investigator (CII) (see http://www.diahome.org). The
ACRP-APPI designation is Certified Clinical
Trial Investigator (CCTI) (see http://www.acrpnet.org).100120 125135 1451531992 1994 1996 1998 2000 2002Figure 11.3 Mean number of procedures per patient [Source:Thomson CenterWatch Analysis, 2004; Parexel Source-
book, 2004–2005; Fast Track Systems, 2004]
11.2 BASIC INFRASTRUCTURE 129