iPhone app makes trial adverse event grading more efficient, easy

Toss the laminated information cards

Researchers and informatics specialists at The Children's Hospital of Philadelphia (CHOP) of Philadelphia, PA, have found a novel way to connect a research tool to popular telephone or hand-held computer technology, making the grading of adverse events (AEs) more efficient and faster.

Although it was developed for use in oncology clinical trials, the tool could be adapted for other types of studies, as well, says Peter White, PhD, director of the Center for Biomedical Informatics (CBMI) at The Children's Hospital. White also is a research associate professor in the division of oncology at the University of Pennsylvania in Philadelphia.

The new tool was developed as an application for iPhones, iPods, and iPads, and it's available for a free download on iTunes online.

The standard classification system for adverse events in oncology research is the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), a 200-page handbook.

The CTCAE standards help investigators quantify the severity of toxicities from anticancer drugs used in clinical trials, says Frank M. Balis, MD, director of the Clinical Cancer Research Center for Childhood Cancer Research and director of the division of oncology at The Children's Hospital.

"The iPhone app developed at The Children's Hospital displays these standardized toxicity grading criteria in an easily searchable and very portable format," Balis says. "We have loaded the app on iPod touches for our clinical research associates, who collect data for our clinical trials."

Research associates then can take their iPods to rounds and ask clinicians to grade their patients' toxicities based on descriptions of the various grades, he adds.

"This allows us to collect these data in near real time while the information still is fresh in the clinician's mind," Balis says.

This type of tool lends itself well to new mobile technology, White notes.

"The reason we were interested in doing this is because some time ago we figured mobile applications would play a significant role in the hospital here," White says.

The informatics center staff had discussions with oncologists about how to create a clinical trials database and registry. One oncologist was trying to figure out a way to standardize how the adverse event reporting occurred.

The oncologist wanted to find a simple and fast way to make the CTCAE information available to clinical trial investigators and coordinators as they observed AEs in study participants, White explains.

"One suggestion was to create a series of laminated cards and make these available to individuals," White says. "While the oncologist was having this discussion with our informatics developers, Mike Italia and Lauren Frazier, he was idly playing with his iPhone on the desk."

Eureka!

The informatics developers suddenly realized that researchers commonly used this technology, and that the CTCAE could be turned into an application on iPhones.

They decided to develop it for Apple's telephone technology because these were homogenous in terms of hardware platform, and only one version would be necessary.

"It's a little more of a controlled environment than the android environment with several different manufacturers and different versions of phones," White explains.

Plus Apple's iPod Touch is relatively low cost, he adds.

The portability of the app also makes the tool convenient. Although it was developed as a research tool, it has crept into use in patient care as clinicians use toxicity grades to determine drug dose reductions in patients receiving anticancer drugs, Balis says.

"The iPhone app is very intuitive so essentially no training has been required," Balis says. "Most people can pick it up and use it because it follows the same conventions as other iPhone apps and the iPhone OS."

The tool is efficient, taking a few seconds and several taps on the keypad to find a CTCAE answer to any adverse event inquiry, White says.

"Especially if you rely on a mobile device for several aspects of the clinical trial then it becomes almost second nature that you're using it, so it saves time," he adds.

Programs like the CTCAE app that bring research tools to the clinical space increasingly will be important to the future of clinical trials.

"Unlike the CTCAE book, you always have it with you if it's on your phone, and you can use it when unexpected problems arise," Balis says.

The next step would be to make adverse event reporting as simple and easy.

"It would be exciting to enter data directly into this system wirelessly using the PDA functions of an iPhone or iPod touch," Balis says.

"Most centers are moving towards paperless systems for patient care and management of clinical trials and the data that they generate," he explains. "Here, we are working to ensure our electronic medical record and clinical trial management system can communicate with each other directly."

An iPhone app that permits data input for clinical trials would help reduce the potential for data input errors, but the transition has many system barriers.

For instance, a device that records AEs from study subjects who also are patients in a hospital's clinical care could be viewed as a medical device by regulatory authorities, White says.

"We haven't explored that option yet," he says. "There's a whole business process you go through to create medical devices, and this would have to be regulated by the Food and Drug Administration (FDA) if we reported it."

Ideally, research sites would have access to a clinical trial management system that is associated with mobile applications, White says.

"There could be an interface between the CTCAE applications we've developed that integrates with a clinical trial management system," he explains.

The key step to take before a clinical trial sites installs new technology is to sit down with investigators, study coordinators, and other users to determine how the change will impact their workflow, White suggests.

"Otherwise you'll build a tool and they won't use it," he adds. "That's happened to us, as well."