Principles and Practice of Pharmaceutical Medicine

Clinical Trials’ and ‘Multinational Investigational
Drug Companies’ by Bert Spilker. Many regula-
tory authorities also provide useful literature and
guidelines on registration expectations. New staff
should carefully review and discuss with experi-
enced sponsor management and have internal doc-
umentation explaining the company’s systems and
processes. Senior-level staff can also attend the
noted and advanced course on international inves-
tigational product development and regulatory
issues sponsored by Tufts University at the Tufts
Center for the Study of Drug Development.

Understanding good clinical practices

Understanding the responsibilities and obligations
of sponsors in terms of good clinical practices is
fundamental knowledge essential to conduct clin-
ical research. Currently, most pharmaceutical firms
reference the ICH GCP Guideline as the minimum
standard for conducting clinical trials. There are
excellent PERI or DIA overview courses covering
good clinical practices.
The responsibilities and obligations include
knowledge of the elements of informed consent,
the role and responsibilities of Institutional Review
Boards/Independent Ethics Committees (IRB/
IEC) and the importance of Clinical Study Quality
Assurance.

Understanding the regulations
of the countries in which drug development
will occur

Although the US Food and Drug Administration
(FDA) historically has been the dominant regula-
toryauthorityintheworld,inrecentyears,theother
regions (e.g. EU and Japan) have emerged to chal-
lenge that dominance. As multinational companies
consider conducting a larger proportion of trials
outside the United States, knowledge of global
regulations has become increasingly important.
An understanding of the regulatory structure,
operations and functions is very important to indi-
viduals new to the pharmaceutical industry or new
to clinical development.

Knowledge and skills are required for com-

munication with the regulatory agencies; covering,

for example, End-of-phase II Meetings, IND/CTA

Annual Report, Advisory Committee Meet-

ings, Pre-NDA/BLA/MAA Meetings, Clinical

Hold, IND/CTA Termination and regulatory ins-

pections.

Competencies associated with planning

clinical development

Conceptualization and development

of clinical development plans (CDPs)

Developing an international CDP to answer ques-

tions defined by the investigational product target

profile is a key activity of senior-level industry

personnel. This competency requires an under-

standing of toxicology and clinical pharmacology

to identify clinical target profile criteria. The CDP

defines the critical path for the clinical program and

the clinical budget. The CDP also defines investi-

gational drug development assessment and deci-

sion points, and the project resource (personnel and

budget) estimates.

CDPs will cover

preparing the clinical section of IND/CTA sub-

mission;

preparing clinical reports needed to support

IND/CTA submissions;

clinical research and scientific methodology;

exploratory INDs (in the United States)/pilot

efficacy studies;

phase I studies;

phase II studies;

phase III studies;

phase IV studies;

pharmacokinetic and bioavailability studies;

3.3 COMPETENCY-BASED TRAINING PROGRAM FOR STAFF ASSOCIATED WITH CONDUCTING CLINICAL TRIALS 27