Handheld Device Improves Toxicity Data Collection

Wireless tablet-sized computers and user-friendly software may soon be helping investigators collect clinical trials toxicity data. A new handheld prototype with all the capabilities of a standard laptop computer was demonstrated at the LENT IV workshop.

"The software guides the user through data entry for patient registration, prestudy, during study treatment, and follow-up," explained Kamal Narang, vice president of software development services for Capital Technology Information Services, Inc., a health informatics company from Rockville, Maryland, that is developing the software.

Dr. Andy Trotti also has contributed to the software design. "The software will help the user find and code any CTC toxicity criteria by using a ‘directed data collection approach,’" Dr. Trotti said.

The software presents to the user a study-specific list of adverse effects recommended for screening based on the type of study being conducted. For example, a patient treated for lung cancer with radiation and chemotherapy will need to be screened for thoracic organ injury as well as the adverse effects expected of the specific drugs in the protocol.

The software will also recognize that adverse effects seen in follow-up are often different than those seen during active treatment, and will adjust the recommended list of adverse events to include late effects.

Mr. Narang commented: "This approach can also be adapted for surgically oriented studies or even for general outcomes data collection in standard clinical practice. We are designing it with maximum flexibility to match the needs of the user."

The system also can perform data analysis or export the data to the NCI or other groups. It will also prompt the user to submit an adverse event report to regulatory authorities based on reporting requirements.