Harnessing new technologies to better evaluate the efficacy of new drugs, regulators in China are beginning to incorporate data, videos, and photos drawn from monitors worn by patients who agree to the use of the information.
The country’s Center for Drug Evaluation (CDE) laid out the need for gathering so-called Patient-Reported Outcome (PRO) data in a draft guidance issued in September. The data, obtained from patients in real-time through the use of smartphones, tablets, and a range of wearable devices, can supplement the results of clinical studies, and traditional patient records.
Still in the pipeline is establishing regulatory guide rails on the use of such technologies, to deal with questions such as the accuracy of different devices, the quality and usability of the data they generate, and the potential for human error in their use.