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The Great Save
A generation of researchers must assure that their data won’t retire with them.

Nancy McCall, Barbara Hawkins and Phoebe Evans Letocha, collections management archivist.

In addition to the old photographs, records and personal papers, there’s a new category of information being meticulously collected and preserved
at the Alan Mason Chesney Medical Archives: clinical trial data.

This summer, ophthalmologist Barbara Hawkins, who retired in June, became the first Hopkins faculty member to entrust the reams of data she had acquired over the last 30 years to the archives.

“Until recently in my group, we just kept data as a trial ended,” says Hawkins. “But now that I’m retiring, it’s time to transfer it. We need to save data so that other researchers can answer questions our database makes feasible.”

The issue Hawkins faced is relatively new—the world’s first randomized clinical trial didn’t take place until 1948, when English epidemiologist Bradford Hill tested streptomycin in treating tuberculosis. By the 1960s, clinical trials were in full swing. Today, as a generation of researchers moves into retirement, many scientists find themselves, like Hawkins, wondering, Now what?

Hawkins’ query to head archivist Nancy McCall, as it turns out, couldn’t have been better timed. The archives had just received a grant to develop a prototype for electronic records management. The goal: to conduct a feasibility study for long-term preservation, access, retrieval and use of critical data and information in digital formats.

Under this broad umbrella, preservation of clinical trial data would be a perfect fit—particularly given that, since 2003, the NIH has required researchers receiving grants of $500,000 or more to have a plan for sharing their data after their trial is complete. Hawkins’ data will be the first clinical trial data at Chesney.

Archiving electronic data has inherent problems because digital files often must be accessed in the same software they were stored in—such as Access or Excel—and software becomes extinct. That’s why Chesney is looking to use an open-source platform, which is not software-dependent. 

On June 30, Hawkins handed over databases on two CDs for two major studies she led (the Macular Photocoagulation Study, 1979-1995; and the Collaborative Ocular Melanoma Study, 1985-2005), as well as paper copies of data collection forms and other documentation. She also had to create detailed documentation for the databases to explain how each was created and organized.

While Hawkins had few qualms about making the hand-off, some researchers do. They worry about their data being taken out of context or being used to criticize the original work. “In the age of meta-analysis, it seems like the data have to be there, and you have to give up control and say someone may do something with my data, but there is that tension there,” concedes Janet Holbrook, an epidemiologist and director at the Hopkins Center for Clinical Trials.

For her part, Hawkins would be delighted to see her wealth of hard-won data generate future interest. “We hope that other researchers who have research questions that can be answered using one of these data-sets or other archives materials will become aware of them and use them,” she says. 

—Kristi Birch



Johns Hopkins Medicine

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