Guest: Roy Vagelos, Merck
Merck’s Finest Hour
Roy Vagelos may be retired, but he remains a legend all the same. The former Merck leader spoke at this year’s Clinical Trials Congress.
The burden of day-to-day responsibilities does not always allow for appropriate reflection on the future. The Society for Clinical Data Management is trying to address that next month in its annual Leadership Forum. Held in Durham this year, it’s for senior-level executives. Space is limited. It’s an intimate, forward-looking gathering intended to allow peers to discuss what they’re grappling with in depth.
This year’s event has been reformatted to have more access to industry thought leaders and FDA officials who will be charting the future of clinical data for the next ten years. All of the presentations at the Forum will be conducted in an intimate, free-form manner to faciitate in-depth discussions between peers.
In this podcast, Anthony Costello, a past chair of the SCDM and a co-founder of Nextrials, discusses some of the highlights for this year’s meeting, including a peek at CDISC’s CDASH forms and an update on a promising integration of electronic health records and 21 CFR Part 11-compliant systems for clinical trials.
the agenda for the meeting.
In talking with Costello, it’s clear the SCDM wants to have this be a meeting that helps attendees be ready for the long-term future that awaits them. Here’s how Costello put it: “We don’t just mean next year. We mean the next several years. Where will data management go? Where will clinical trials go? Where especially is technology going, because it’s changing so quickly? And how can we get the best and the brightest people in the room and really think about how our industry is going to change over the next five or 10 years?”
There are several high level FDA speakers on the agenda of the meeting, including Rachel Behrman. We asked Costello about that. “Obviously, FDA created the Critical Path initiative to be a leader in this space. So it just makes sense to have the leaders from the regulatory body participating in an open forum like this with the leaders from the industry.”
July 4, 2009
Roy Vagelos may be retired, but he remains a legend all the same. The former Merck leader spoke at this year’s Clinical Trials Congress.
In 2009, it is easier and more feasible to connect two vast data cosmos that have long existed separately. The electronic data capture (EDC) systems for clinical research are slowly being connected to larger, more general-purpose electronic health record (EHR) systems for physicians.
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.
The burden of day-to-day responsibilities does not always allow for appropriate reflection on the future. The Society for Clinical Data Management is trying to address that next month in its annual Leadership Forum.
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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