Introduction

Traditionally, clinical trials have involved patients going to the trial site to submit results or partake in the pre-defined trial activities and these locations can include hospitals, universities, medical centres, community clinics etc. However, as technology has become increasingly innovative and our global reliance has manifested, we’re beginning to see the methods of clinical trial data collection swing to the use of wearable devices. One such example is the use of ingestibles to monitor stomach acid levels1 being researched by Researchers at MIT and Brigham and Women’s Hospital. These types of technology have also been tested to “sense physiological conditions such as temperature, heart rate, and breathing rate, or to deliver drugs to treat diseases such as malaria.” Yet, whilst these efforts may be more patient-centric, questions are beginning to be raised concerning that data, such as:

• What exactly is happening to the data collected?
• How can patients be certain of its collection purposes?
• How secure is its collection and storage?
• Is its integrity remaining intact?

We delve into these issues and more throughout this guide and hope to address concerns you may have – or hadn’t even thought about.