The future of clinical trials mobile technology and its impact:
Traditionally,all the earlier clinical trialshave been recorded using paperdocuments according to the rule 21.CFR.312.62(b). However,by the end of 1997,a new set of regulations, called Part 11, was published which introduced electronic records in lieu of paper records.This made the use of mobile technology feasible in clinical trials and since then this technology has been used toengage with patients and collect their data during clinical trials.
The mobile technology has been evolved to include mobile phones and other devices in the clinical trials. They provided a means for the investigators to communicate with theirsubjects/patients across broad demographics and multiple locations. The mobile technology became an effective system for sending reminders to ensure timely actions such as clinic visit attendance, fasting, correct medication intake etc.Further, the use of smartphones and tablets revolutionized the procedures of data collection, thevery important step of clinical research.
Wearable devices, commonly known as wearables, are other mobile devices which gained popularity in the recent times. They include pedometers, watches, wristbands, chest bands, patches, headsets. All these devices are simple to wear and they generally combine sensors for biometrics. Different wearableshelp to measure a range of patients’ physiological parameters such as steps taken, heart rate, electrocardiograms, glucose levels, and brainwaves etc. The biggest advantage of wearables is that they continuously record the data in real-time and enable the investigators to track clinical trial participant status between site visits. Almost all the mobile technology using devices are now-a-days paired with suitable mobile application, or an App. These applications are used for data logging which can then be accessed remotely by the investigators and thereby reducing/eliminating the number of theirfield visits. Some of the sophisticated wearable devices record very accurate and measure a wider range of biometric and physiologic data which can be effectively used to characterize diseaseseverity and progression.
Thus, the mobile technology became a popular tool in clinical trials by providing potential benefits such asenhanced communication between the patient and investigators, collection of automated and continuous data, reducing the burden of field visits etc.