New iPhone App Lets Users Record, Share Clinical Trial Data

A new app for the iPhone and iPod touch provides physicians and nurses with mobile access to the reference information contained in the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Developed by the Center for Biomedical Informatics (CBMi) at The Children’s Hospital of Philadelphia, the app enables users to locate and search through possible adverse events that may occur to patients in a clinical trial, and record any side effects that they encounter.

From an alphabetized list of symptoms, users can tap in “ear pain” or “tremor,” and the touch screen will display a definition, and then list grades of the problem—mild, moderate or severe. Using these categories, a care provider or clinical trial researcher can log data into the trial’s records, so it can be shared with other hospitals and physicians who have patients participating in the same trial. A user can bookmark adverse events and categories that require more frequent access.

“Researchers can use this app to quickly access information at the point of care, and improve the efficiency of our research,” said Peter C. Adamson, MD, director of the Office of Clinical Translational Research at Children’s Hospital, and chair-elect of the Children’s Oncology Group.

Although the classifications used in CTCAE originated in oncology research, they have broader application in clinical trials for other conditions, according to Peter White, PhD, director of CBMi at Children’s Hospital, and a leader of the team that created the app. “When researchers write the protocol for a clinical trial, they know that one element of patient protection is standardized record-keeping, so they may incorporate the CTCAE rubric in their protocol.”

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