26 Data Management

T.Y. LeeandMichael Minor

Pharmaceutical research and development is a
lengthy (8–12 years) and costly process (approxi-
mately $500 millions in 2001). It starts from dis-
covery of the compound, biological screening,
animal toxicological studies, formulation, assay
development/validation, clinical pharmacology, sta-
bility testing, clinical trials, data management, sta-
tistical and clinical evaluation, new drug application
and promotional marketing. At each stage of the
research and development, data are generated, pro-
cessed and validated before being subject to statis-
tical analysis. Data management plays a significant
role in assuring the government agency and consu-
mers that the database represents a pool of informa-
tion that was accurately collected and processed and
logically presented. With the advancement of phar-
maceutical technology in identifying new com-
pounds, and improved efficiency in software
support and information processing, the duration
of exclusivity enjoyed by a new drug has been
drastically reduced before a competitive drug of
the same or a similar class reaches the market. For
example, the duration of exclusivity (PhRMA,1997)
for several major drugs is summarized in Table 26.1.
Becauseof theacceleratedshortening ofthedura-
tion of the exclusivity, the pharmaceutical compa-
nies tend to initiate clinical trials in several countries
simultaneously to obtain worldwide clinical data.

This strategy will give the pharmaceutical compa-

nies a chance to market the drug in many countries

simultaneously and recover as much cost as possible

before the competitors join in. To collect worldwide

data and pool them together presents a special chal-

lenge to data management professionals. It is neces-

sary to consider differences in culture, medical

practice, laboratory standards/units, classifications

of disease and medication, drug reactions, religion,

self-medication, drug interactions and so on. There-

fore, a detailed and coordinated data management

plan, standard operation procedures, quality control

(QC) and quality assurance (QA) are essential to

produce a reliable database.

26.1 Obtaining the project

material

To develop a data management plan pertinent to the

project, a checklist of the project material is neces-

sary to enhance the planning. The items to be

collected include the protocol, annotated case

report forms (CRFs), literature, log-in and tracking

forms, file structures, coding rules, CRF review

conventions, query handling procedure, required

edit checklist, central laboratory address/file

format, laboratory normal ranges, clinically

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9