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Clinical Trials Leave Paper Behind


By Joseph Goedert, News Editor September 2006
For Jerry Miller, M.D., president at 92-physician Holston Medical Group in Kingsport, Tenn., clinical trials are good science and good for patients. "Modern health care and best practices today must be based on clinical research," he says.

Trials also are a good revenue generator, bringing in $2.5 million last year to 26-site Holston. For more than five years, Holston has used the TouchWorks electronic medical records software from Chicago-based Allscripts LLC and the Study Manager clinical trials management application of Seattle-based Advanced Clinical Software to support the trials.

Through the Allscripts EMR, the practice has the clinical data readily available for assessment of the efficacy of a new drug, process or treatment method. The Study Manager software helps organize business and payment processes of trials, and the recruitment and tracking of patients.

Miller is sold on using I.T. to support clinical trials and when Allscripts and Advanced Clinical Software recently agreed to integrate their products, Holston became a pilot site.

When the integration is complete, the practice no longer will have to double-enter demographic data and other information in both TouchWorks and Study Manager. "Every moment I have to spend entering demographics into a computer is time I'm not spending with patients," says Joyce Caldwell, director of clinical research at Holston.

Miller estimates 150,000 physicians in the United States participate in clinical trials, and the majority of them do not have electronic records. "How they do it, I don't know," he adds.

Most clinical trials still use paper documents to collect information from participating organizations and physicians because many providers, especially small practices, do not have the capability to collect, track and transmit digital data.

However, I.T. has been put on the fast track. Trial sponsors-such as pharmaceutical manufacturers and research and advocacy groups-increasingly are offering specialized information technology tools to providers and patients.

These tools include trials management and report writing software, databases and data management tools, electronic diary software loaded onto PDAs, "smart" pillboxes that record patient medication compliance, and "smart" shirts using tiny fibers and sensors to record and transmit physiological data.

In addition, some providers are leveraging their own I.T. investments. The large group practices and academic facilities coordinating clinical trials often are "above the curve" in I.T. adoption, says Steven Tobin, industry analyst for health care information technology at Frost & Sullivan, a San Antonio-based research firm.

"As they continue to implement clinical I.T. systems, they push them into trials," he adds.

Although it plays an important role, information technology remains a tool and not the differentiator between trials that succeed and fail, Tobin believes.

"Some people think I.T. is the end-all data aggregator and will spit out all their reports," he notes. "But clinical trials are all about process management and the human touch."

Yes, but...

Software that spits out reports may not be crucial to conducting a clinical trial, but it sure is nice, experts say, even if a research site is using only a fraction of the software's capability.

Susan Shoaf, assistant director of clinical pharmacology at Otsuka Maryland Research Center in Rockville, uses software from Seattle-based Insightful Corp. to speed creation of her reports.

The S-PLUS statistical data analysis software uses templates and automated pulling of pertinent data from information systems to create a variety of standard reports for researchers, sponsors and regulators. Automatically formatted and with footnotes, the reports can be created as Microsoft Word or PDF documents.

Many studies have standard reports covering such topics as a drug's effect on the liver, whether the drug is equal or better than standard treatment, and how much of a drug is absorbed into the bloodstream and actually fighting the disease, which is important for determining dosage requirements.

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