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Welcome back. We hope the first edition of the Clinical Research Connection was of value to you; and that each subsequent issue includes information you can use; as well as an opportunity to increase communication and interaction.
Providing a vehicle for our affiliate members to share news, ideas and suggestions, reports on ECOG meetings and programs, and call attention to high-priority trials, are some of the goals for this newsletter. What else would you like to see? What kind of articles would facilitate our joint efforts? Please send Vera Jackson your feedback and suggestions at affiliates@northwestern.edu.
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There have been plenty of changes since the Clinical Research Office's Regulatory Operations Manager, Jeff Atkinson, joined the Lurie Cancer Center in 1996. In the early days, he was the one and only Regulatory Coordinator. He remembers when, with the help of one department assistant, all official communications were done on paper and hand-delivered—with original signatures. "Looking at how far we've come since then," he says, "I feel like someone relating stories about trudging five miles to school in the snow!"
In the years that followed, the CRO's regulatory team has grown to six full-time staff members, and they directly manage regulatory for close to 600 studies. In addition, the work required for each study has grown exponentially; due in part to the growing affiliate network. "We are the Northwestern IRB's biggest user. Thankfully we are increasingly (and immeasurably) aided by the ability to communicate - and even submit - the majority of our work electronically," says Atkinson.
Regulatory isn't necessarily work that everyone immediately appreciates, Atkinson concedes, " but one of the aspects of regulatory I find gratifying is our unique responsibility to facilitate critical interactions between those doing the research (sponsors, investigators and affiliates) and oversight agencies (primarily the IRB). Our goal is really to take over as much of this day-to-day regulatory work from investigators as reasonably possible while remaining in compliance. The ultimate source of gratification, of course, is the ability to contribute to the greater good and help others."
Contact Jeff Atkinson at j-atkinson@northwestern.edu or 312.695.1397.
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