As a trustee of the Society for Clinical Data Management (SCDM), Paul Clarkson is the archetype of the data manager who understands the largest issues affecting clinical development. As director of data management at Genentech, he’s been thinking about how data managers can help their organizations develop better protocols.
Clarkson attended the March, 2008 SCDM Leadership Forum, and was a frequent and savvy interrogator of the conference speakers from the floor of the meeting. Which is by design: the SCDM meeting is intended to foster discussion within the senior-level attendees. A bit more time is alloted to each speaker to allow for time for that dialogue.
ClinPage got a few minutes of Clarkson’s time to discuss a recurring motif during the meeting: the smart protocol. In brief, the idea is to make sure that the most important data is collected—and that a clinical trial does not become the medical equivalent of a glove compartment, where odds and ends are kept for no particular reason. The percentages of data that may not be essential are surprising, and Genentech has developed ways to identify and review which data elements should remain in the protocol and which can safely be eliminated. The methods Clarkson discusses are technologically simple but operationallly sophisticated in a context of how large biopharma companies and trials tend to be governed.
Clarkson is discussing timely issues that many life sciences companies are struggling with. The industry is wrestling with how the role of data management should change in an era in which many of the traditional aspects of the job (thanks to computers) are less relevant. Many organizations will need to figure out the timeless, eternal aspects of the data manager role—and which can safely be put to rest.
The transcript is 10 pages long, and provides an unfiltered record of the conversation.
September 3, 2010
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As a trustee of the Society for Clinical Data Management (SCDM), Paul Clarkson is the archetype of the data manager who understands the largest issues affecting clinical development. As director of data management at Genentech, he’s been thinking about how data managers can help their organizations develop better protocols.
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Gartner’s Carol Rozwell is one of the industry’s leading authorities on technology adoption and clinical data standards. In this illuminating interview with ClinPage editor Mark Uehling, she discusses why some organizations hesitate to use CDISC standards and how some contract research organizations (CRO) have recently begun to see data standards differently.
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