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

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