Pharmaceutical Executive Europe - March 2007 - (Page 24)
The Right Equipment With the multitude of customizable and configurable
randomization tools available, how do you know which one is right for the
trial you’re conducting? Ann Seidel discusses the pros and cons of
different methods. T he process used by a clinical project team to collect
screening, enrolment and randomization information for a clinical trial can
have significant impact on the successful completion of the trial. There
are many factors that should be evaluated so that the most appropriate
methodology is selected; one that optimizes patient participation, ease of
patient entry, and integrity of the data in the most efficient and
costeffective manner. Many diversified tools are available to support
centralized randomization, ranging from low-cost, fast start-up, web-based
solutions that allow limited trial specific configuration, through to fully
customizable web- and phone-based systems such as interactive voice
response systems IVRS . The aim of this article is to highlight the
factors that must be considered when selecting the tool that best fits the
needs of a specific trial. Web-based patient screening To select the
optimal collection process it is first important to evaluate the type of
information that needs to be collected by the system selected. The
clinical protocol should be used as the starting point in the
decision-making process. While the protocol may specify that screening is
to be performed at the site to determine eligibility, the protocol will
not likely specify 24 in detail how the information is to be recorded. The
length of the screening period, the complexity of the data collected, the
format of the case report form, as well as other considerations, should be
taken into account as decisions are made regarding the data collection tool
used for screening Table 1 . Commonly, systems used to collect screening
data are paper-based and are frequently part of the case report form used
for patients who are ultimately enrolled or randomized. Paper-based
systems are easily deployed and require comparatively few resources to
design. Paper-based systems become more costly to maintain since, in terms
of their ongoing utility, the information recorded must subsequently be
transferred or entered into a data collection tool in order for
summarization or analysis to occur. The subsequent data entry, any
necessary reconciliation, as well as quality or verification measures
should be considered as part of the true overall cost of using a
paper-based system. Paperbased systems also tend to entail the added
disadvantage of delaying sponsor access to study information, which can
impact decision making. An automated screening system has advantages when
screening medication is assigned, especially when supply is limited. There
may be advantages to automation when the screening period is lengthy and
MARCH 2007 CLINICAL TRIALS MANAGEMENT
Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007
Content
Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna
Pharmaceutical Executive Europe - March 2007
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