Apple’s ResearchKit has made significant inroads into medical research studies that are open to a broad audience. They don’t require medical intervention, and participants can self-select and sign up.
The main reason that Apple ResearchKit has been so successful is the fact that research study participation can be increased through mobile apps. This is because study participants can participate at their convenience and on their terms.
There are no paper forms to fill out and no phone surveys. The mobile app makes providing data easy and, in many cases, prepopulates the study responses from device data collected by their smartphone.
Universities and hospitals have released research apps in a variety of ways to collect responses in both standard and innovative non-standard ways.
The untapped area in the research space is with the use of mobile apps in the pharmaceutical industry for clinical trials. These trials are usually highly controlled and require data to be entered by the study investigator or by qualified medical personnel.
There’s not much data provided directly by the patient, especially in early phase trials. However, there’s still a strong case for using ResearchKit apps in these situations. The only difference here is that the app would be used by the investigator instead of the patient to provide data for the study.
It’s the mobile app version of the CRF form where ResearchKit fits in here. It streamlines the process of data gathering through a customized framework according to the steps involved in the research study.
With sophisticated verifiable digital signature technologies, data validation and correction at the source, as well as the implementation of robust security, the use of mobile apps in clinical trials could be the next big thing for the Pharma Industry.
ResearchKit is also particularly useful in Phase 4 trials where the amount of self-reported data provided by the patient is higher.
There’s also a good use case to be made to tie Apple’s CareKit into the research process. CareKit can be used to build mobile apps targeted towards patients to serve up medication reminders, appointment notifications, and more to help them participate in the study, keep track of their activities, and ensure that they stay motivated to continue participation.
Apple ResearchKit is flexible enough to work in different situations. And, it’s the responsibility of the mobile app developer to ensure that the app is compliant with research guidelines.
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