Innovative clinical trials performed in an outpatient setting

Highlights

  • This hi-tech, yet remarkably simple approach has transformed the way we conduct outpatient clinical trials.
  • With this approach, much larger patient groups can be studied on an outpatient basis while they go about their normal daily life.
  • Increases both patient compliance and the quality of the data.

Increased patient compliance and improved data quality with Trial@ Home

At CHDR, the Trial@home approach has been extremely successful. It has been combined with another of CHDR innovations – the Monocentre approach – for use in outpatient dermatology studies.

To accurately and consistently measure the effects of a new dermatological treatment, the compound must be applied at regular intervals for several days, and each subject’s compliance with the protocol must be documented. With Trial@Home approach, patients visit CHDR for an initial examination. If the patient meets the study’s inclusion criteria and provides informed consent, he/she then receives the study medication, instructions for its application, and an app customised to meet the specific needs of the study. This app plays a key role in ensuring:

− patient compliance: the app prompts the patient to apply the medication at designated times;

− documentation: the patient uses the app to take a picture of the treatment area, confirming that the medication was applied correctly and at the correct time;

− data collection: using the app, the patient answers questions about daily complaints such as pain, itching, and/or irritation, as well as questions regarding quality of life.

All of the data collected with the app are encrypted and securely transferred to CHDR at regular intervals. If a patient does not send data for several days, he/she can be contacted by the project leader. Trial@Home has been used successfully for several clinical studies conducted in recent years, and we’ve found that it significantly increases both patient compliance and the quality of the data.

Wearable devices

To collect data from subjects while they go about their daily business, both at home and around town, CHDR is developing portable devices that contain biosensors for monitoring and recording electrical currents, movement, body temperature, blood/tissue oxygenation, and other parameters. These so called ‘wearables’ transmit data to a mobile device such as a smartphone or tablet; at regular intervals, the data are then transmitted securely to a central database at CHDR. In addition, subjects can complete brief questionnaires on their mobile device, and they can take pictures of their lesion (for example, in a dermatology study) or their medication (for example, to show compliance with the protocol). If the study calls for biochemical parameters, a courier can be sent to collect saliva, urine, or other biological samples.