The Clinical Data Liaison: The Key to Better, Faster Clinical Trials
Date: 05/5/2008
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Length: 00:05:33
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Thought Leader: John Hudak, President and Founder, Criterium Inc.
In this episode, John Hudak, talks about the need for a paradigm shift in work flow to improve the clinical trial process and how the evolving role of a centralized clinical data liaison, or CDL, is integral to streamlining data management. Mr. Hudak also discusses how through real-time feedback, the CDL can reduce the number of field monitoring visits required, a major cost in managing clinical studies, and improve overall site efficiency.
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Transcript:
I’m Taren Grom, editor of PharmaVOICE. Welcome to the PharmaVOICE videocast network and this episode of the industry vision. I’m here today with John Hudak, President and Founder of Criterium, Inc., who is going to talk about a major shift in the area of workflow management of clinical studies.
Welcome, John.
John: Glad to be here, Taren.
Taren: As an industry veteran, you’ve laid the groundwork for many innovative advances in the clinical research field. Tell our audience what's new in terms of improving the clinical trial workflow today.
John: Taren, there are two major areas that have always effected the workflow in clinical studies; how quickly the data comes in as a function of patient enrollment and what one does with the data when it does come in.
Electronic data capture is a catchphrase that people use today, but the application of technology alone to traditional workflow does not solve the problem. To overcome these challenges, the industry needs to change the workflow paradigm by disciplining itself to pay attention to data as they become available.
One way to do this is to go from a distributed system of periodically cleaning data, to a centralized management process that puts value on reviewing data in real time. This can be done today because there are robust cost effective technologies, such as IVR, EDC and fax that give you a mechanism to receive data everyday. But managing this new process requires a new type of role, which I call the clinical data liaison.
Taren: That’s very interesting, John. Can you please give us your definition of a clinical data liaison.
John: Yes. The clinical data liaison (CDL) is a new role that will become a standard in the industry for companies that want to make more efficient use of limited resources, time and money. The CDL position is key in that they conduct real-time data review and facilitate centralized control of clinical studies.
With the assistance of technology that delivers the CRF data to dedicated processing centers, the CDL position combines clinical research training skills of the clinical monitor and the data expertise and discipline of a clinical data manager with the benefit of having cumulative databases at their fingertips.
Taren: That’s innovative. How does a clinical data liaison positively impact the clinical trial process?
John: The clinical data liaison has significant impact in two key areas. First, because they review the CRF data in real time, editing can take place within days of a patient visit so that the correction process goes more efficiently. The CDL team also provides the tools to manage the field monitors visit schedules by profiling the quality of each site and determining which sites require more or fewer visits. Correcting data errors directly with those sites reduces the field monitor’s work at the site during each visit, allowing them to concentrate on source document review and reducing the number of field monitoring visits required, a major cost in managing clinical studies.
Second, because the workflow allows the CDL to integrate the data into the database as it is received, updated information about the study can be incorporated into reports provided to the field staff, the sites, and the sponsor. For example, one of the key benefits is that the CDL team can profile those screened patients who become screen failures and those who are randomized successfully. These profiles can be provided directly to the sites and in some studies, allow you to reduce the number of screened failures, a major cost in time saving.
Taren: That sounds great. I’m sure there is a fair amount of process change involved to achieve these benefits. But in today’s global economy, how does the liaison role flatten the process?
John: The clinical data liaison flattens and definitively improves the workflow in three ways. First, there is no hierarchy or barrier to the flow of the data. Data are reviewed and queried in a continuous process that spreads the burden more evenly among the coordinators, the field monitors and the clinical data management staff.
Second, because the workflow is continuous, at no time does the job become overwhelming or slopping. The ‘clean as you go’ philosophy allows everyone to do their job better.
Third, the data become timely and useful information, which is available to all stakeholders for decision making that can effect the outcome of your study.
Taren: Thank you, John, for an informative look at this changing paradigm and how clinical trial liaisons will impact the workflow process in the future.
John: Thank you, Taren. It was my pleasure.
Taren: If you would like more information about how clinical data liaisons can positively impact your next study, or about Criterium, please visit www.criteriuminc.com.
Thank you for joining us for this episode of the industry vision.
Don’t forget to check out our other videocasts at www.pharmavoice.com/videocasts.
If you have any comments on this episode, or if you’d like to be featured in a feature videocast, send an email to feedback@pharmavoice.com.
Thank you.
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