Navigating Regulatory Requirements for Mobile Devices in Clinical Trials

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Applied Clinical Trials

I've notice of late quite of lot of confusion over the approval requirements that apply when using mobile devices in clinical trials.

I’ve notice of late quite of lot of confusion over the approval requirements that apply when using mobile devices in clinical trials. It’s understandable, as for many the use of mobile technology in clinical trials is a new step.

The advances in technology, not just mobile phones but also medical devices and the advent of lifestyle devices and wearable technologies, have created enormous opportunity for clinical studies to collect data from patients. But with this has come an aura of complexity as the clinical community try to apply the appropriate regulatory guidance. Combine that with recent regulations, such as the guidance for Mobile Medical Applications released last year by the FDA and it can be easy to misinterpret the focus for each piece of guidance. 

The important consideration for those wishing to use mobile devices in clinical trials is to clarify the scope for each piece of guidance. For example both the Mobile Medical Applications guidance and 510(k) clearance for medical devices have commercial focus and only apply for marketed products.

Use of mobile devices within clinical trials should be included as part of the submission to the Ethical Review Board (ERB) or Institutional Review Board (IRB). The level of approval required is dependent on the role of the device within the trial, but can broadly be segmented into 2 categories

1) Conduit to transmit data to the eCRF 

This could include a medical device transmitting results to an app, or an app transmitting data (collected manually or via Bluetooth) to the eCRF (electronic Case Report Form). The key is the app simply transmits data without manipulating it in any way.

In this case the provider must simply comply with the FDA eSource Data Directive by conducting validation to show the data is not transformed, i.e. prove that nothing has changed from device to database.

2) More complex device, transforming data, or making decisions


In our experience developing mobile platforms for use in clinical trials there are cases where the mobile device transforms data in some way. For example in adaptive trials an app might recommend a change in dosing following entry of data that meets pre-defined criteria.

In such cases a greater level of validation is required and it is advisable to conduct a regulatory review prior to commencing the study, though this can be achieved as part of the overall ERB/IRB review. 

We’ve been incorporating mobile phones into clinical research for almost a decade. Over this time the advances in capabilities have provided a raft of possibilities for enhancing clinical research. The key to unlocking these possibilities is the ability to apply the right technology, and the right level of interaction to each trial. 

Through this approach we see pharmaceutical industry beginning to extend the support mobile offers during clinical research into the post marketing, real-world healthcare arena, going ‘beyond the pill’. Of course the regulations like Mobile Medical Apps and 510(k) are applicable for such commercial applications, and as such a forward thinking approach using the appropriate processes and associated documentation can ease burden of market submissions, using the data gathered through the clinical research to support the commercial application.

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Originally posted